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Trial registered on ANZCTR
Registration number
ACTRN12615000177550
Ethics application status
Approved
Date submitted
2/02/2015
Date registered
23/02/2015
Date last updated
11/01/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A study for participants with cancer who experience ongoing nausea, not related to their treatment, despite taking standard and usual medications, that studies the effectiveness of oral methotrimeprazine versus oral haloperidol.
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Scientific title
A randomised, controlled, double blind study of oral methotrimeprazine versus oral haloperidol in patients with cancer and nausea not related to anticancer therapy (Nausea study 3), to compare the effectiveness of oral methotrimeprazine versus oral haloperidol in improving the management of nausea in patients with cancer and nausea not related to anticancer therapy.
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Secondary ID [1]
286085
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NIL
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Universal Trial Number (UTN)
N/A
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Trial acronym
Nausea study 3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patients with cancer and nausea not related to anticancer treatment.
294084
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Condition category
Condition code
Cancer
294392
294392
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0
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Any cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomized to receive either blinded encapsulated oral methotrimeprazine (6.25mg ) or oral haloperidol (1.5mg ) both given once daily (od), for three intervention days. All other regular antiemetics will be discontinued. Metoclopramide 10mg every 6 hours subcutaneous or oral (max dose 30mg/24hrs taken at any time during the intervention as long as it is 4 hours apart) will be available as a rescue antiemetic as well as Domperidone 10-20mg up to four times per day, per oral as an alternative to metoclopramide (taken when needed during intervention period). In the absence of response at 24 hours or 48 hours, the dose of the study drug can be increased to twice daily (total daily dose 12.5mg methotrimeprazine or 3mg haloperidol). All study drug/bottles to be returned at completion of study or study withdrawal/exit.
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Intervention code [1]
291078
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Treatment: Drugs
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Comparator / control treatment
Haloperidol is the standard treatment by which the methotrimeprazine will be compared to.
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Control group
Active
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Outcomes
Primary outcome [1]
294184
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Response to treatment, at 72 hours from time of first study drug administration, defined as more than or equal to a 2 point improvement from baseline for average nausea over the preceding 24 hours on an 11 point nausea NRS
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Assessment method [1]
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Timepoint [1]
294184
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Response to treatment at 72 hours
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Secondary outcome [1]
312718
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Complete response defined as at least a two-point improvement from baseline and a score less than 3 for average nausea over the preceding 24 hours, using an 11-point (0-10) Numerical Rating Scale.
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Assessment method [1]
312718
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Timepoint [1]
312718
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measured at 72 hours from time of first study drug administration
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Secondary outcome [2]
312719
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Response defined as equal too or more than 2 point improvement from the baseline average nausea score over the preceeding 24hours on an 11 point (0-10) Numerical Rating Scale.
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Assessment method [2]
312719
0
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Timepoint [2]
312719
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Assessed at 24 hours, 48 hours post first study drug administration.
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Secondary outcome [3]
312720
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Best nausea score over the preceding 24 hours, using an 11-point (0-10) numeric rating scale
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Assessment method [3]
312720
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Timepoint [3]
312720
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measured at 72 hours from time of first study drug administration
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Secondary outcome [4]
312721
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The number of rescue antiemetic doses delivered as per the inpatient medication chart or the participants diary of medications as an outpatient.
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Assessment method [4]
312721
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Timepoint [4]
312721
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+24hr, +48hrs, +72hrs from first study drug administration.
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Secondary outcome [5]
312722
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Toxicity, assessed by adverse event list.
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Assessment method [5]
312722
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Timepoint [5]
312722
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+24hrs, +48hrs, +72hrs since first study drug and then weekly for 4 weeks post intervention.
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Secondary outcome [6]
312724
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The number of episodes of vomiting experienced (episode of vomiting considered a 20 minute period - dry retching not included) documented on the Case Report forms for the 24 hour period after study drug as per the participant or nursing staff if an inpatient.
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Assessment method [6]
312724
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Timepoint [6]
312724
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Assessed at 24 hours, 48 hours, and 72 hours post first study drug administration and then weekly for four weeks.
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Secondary outcome [7]
312887
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complete response defined as at least a two-point improvement from baseline and a score less than 3 for average nausea over the preceding 24 hours, using an 11-point (0-10) Numerical Rating Scale.
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Assessment method [7]
312887
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Timepoint [7]
312887
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Assessed at 24 hours, 48 hours post first study drug administration.
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Eligibility
Key inclusion criteria
1. are 18 years or over
2. have a clinical diagnosis of cancer
3. have nausea with an average score over the last 24 hours of greater than or equal to 3 on an 11 point numerical rating scale (NRS) anchored at 0 (no nausea) and 10 (worst possible nausea)
4. are able to tolerate oral medications
5. are able to comply with all trial requirements
6. are able to provide fully informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. have nausea related to the treatment of cancer (i.e. surgery, chemotherapy, radiotherapy) within 5 days of anticancer therapy
2. have nausea for which a specific antiemetic is indicated and randomisation to study medications alone would not be appropriate (dexamethasone for acutely raised ICP, 5HT3 antagonists for chemotherapy induced nausea/vomiting)
3. are to undergo a procedure or intervention with the potential to affect nausea during the 3 day study period (eg chemotherapy or radiotherapy to a site likely to cause nausea)
4. have received methotrimeprazine or haloperidol at doses equivalent to dose level 1 per day within the previous 48 hours
5. have had uncontrolled nausea despite treatment with methotrimeprazine or haloperidol at study doses within the previous 2 weeks
6. if on corticosteroids, the dose has changed within 48 hours prior to study or is likely to change during the 3 day study period
7. have a definite contraindication to methotrimeprazine (severe hepatic impairment (LFTs above 5 x upper limit of normal, symptomatic postural hypotension, phenothiazine hypersensitivity, concurrent treatment with MAOIs, severe renal disease (eGFR less than 30), severe myocardial disease (clinician assessment))
8. have a definite contraindication to haloperidol (Parkinson’s disease, movement disorders, severe hepatic impairment)
9. documented congenital or acquired (drug induced#) QTc prolongation (QTc greater than 440sec in men and greater than 0.46sec in women, calculated manually as per Bazett’s formula) or factors that exacerbate QT prolongation ie untreated hypokalaemia, hypothyroidism or bradyarrythmias
10. uncontrolled epilepsy or glaucoma
11. concurrent treatment with monoamine oxidase inhibitors
12. have had a previous adverse reaction to the study medications
13. are pregnant or breastfeeding
14. have participated in a trial of a new clinical entity within the last 28 days
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The clinical trials pharmacy is responsible for the allocation of treatment arms.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedules will be developed for each site using random number tables, generated at an independent centre (central registry). Treatment for each patient will be allocated according to a block randomisation schedule held by the central registry in a 1:1 ratio. Block randomisation within centre will ensure even allocation to each code in each site.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Our assumptions for sample size are based on others’ research and some of our own work. Allowing 20% for attrition, and with response rates of 85% for methotrimeprazine compared to 60% for haloperidol, it is anticipated that 126 participants (63 per treatment arm) should be randomized to achieve a sample size of 50 participants per arm, assuming 80 % power, a simple random sampling scheme and a Type 1 error of 5% (two-tailed).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/03/2015
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Actual
26/03/2015
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Date of last participant enrolment
Anticipated
5/03/2018
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Actual
6/02/2017
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Date of last data collection
Anticipated
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Actual
9/02/2017
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Sample size
Target
126
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Accrual to date
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Final
121
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
3381
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [2]
3382
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Mater Private Hospital - South Brisbane
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Recruitment hospital [3]
3383
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Noarlunga Private Hospital - Noarlunga Centre
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Recruitment hospital [4]
3384
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Repatriation Hospital - Daw Park
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Recruitment hospital [5]
3385
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [6]
3386
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Barwon Health - McKellar Centre campus - North Geelong
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Recruitment hospital [7]
3387
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [8]
3388
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [9]
3389
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St Vincent's Hospital Brisbane - Kangaroo Point
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Recruitment hospital [10]
3390
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [11]
4331
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Flinders Private Hospital - Bedford Park
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Recruitment hospital [12]
5324
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Greenwich Hospital - Greenwich
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Recruitment hospital [13]
5995
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Caritas Christi Hospice - Kew
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Recruitment postcode(s) [1]
9166
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4101 - South Brisbane
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Recruitment postcode(s) [2]
9168
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4169 - Kangaroo Point
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Recruitment postcode(s) [3]
9169
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5168 - Noarlunga Centre
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Recruitment postcode(s) [4]
9170
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5041 - Daw Park
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Recruitment postcode(s) [5]
9171
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5042 - Bedford Park
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Recruitment postcode(s) [6]
9173
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3220 - Geelong
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Recruitment postcode(s) [7]
9174
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3215 - North Geelong
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Recruitment postcode(s) [8]
9175
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3065 - Fitzroy
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Recruitment postcode(s) [9]
9176
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2010 - Darlinghurst
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Recruitment postcode(s) [10]
12786
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2065 - Greenwich
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Recruitment postcode(s) [11]
13420
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3101 - Kew
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Funding & Sponsors
Funding source category [1]
290673
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Government body
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Name [1]
290673
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NHMRC Research Grant
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Address [1]
290673
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
290673
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Palliative Care Clinical Studies Collaborative (PaCCSC)
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Address
Flinders University
School of Medicine
Department of Palliative and Supportive Services
C/- Daw House Hospice
700 Goodwood Road
Daw Park SA 5041
AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
289366
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University
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Name [1]
289366
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The Queensland University of Technology
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Address [1]
289366
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GPO Box 2434
Brisbane, QLD 4001
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Country [1]
289366
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
292303
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The Royal Brisbane and Women's Hospital HREC
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Ethics committee address [1]
292303
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Royal Brisbane and Women's Hospital Level 7 Block 7 Butterfield Street, Herston, QLD Australia, 4029
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Ethics committee country [1]
292303
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Australia
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Date submitted for ethics approval [1]
292303
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10/11/2014
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Approval date [1]
292303
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01/12/2014
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Ethics approval number [1]
292303
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HREC/14/QRBW/466
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Summary
Brief summary
This study aims to find out if a drug called Nozinan (methotrimeprazine) works better in treating nausea that is cancer related than the standard drug Haloperidol. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have cancer related nausea to a certain level of nausea that is not from cancer treatment. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive Nozinan tablets once daily (up to twice daily if necessary) for 3 days, whilst participants in the other group will receive Haloperidol tablets once daily (up to twice daily if necessary) for 3 days. Neither you nor the research team or Doctor will know which drug you will get. You will also have access to two other 'rescue' nausea medications as a back-up for your nausea. You will be required to fill out questionnaires related to your nausea/symptoms before the study drug starts, every 24 hrs after the drug is taken, when the study drug finishes, and for four weekly follow-ups. You can be an in-patient or an outpatient to complete this study.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
54550
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Prof Janet R Hardy
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Address
54550
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Director of Palliative Care Mater Misericordiae Ltd Raymond Terrace South Brisbane QLD 4101
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Country
54550
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Australia
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Phone
54550
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+617 3163 2775
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Fax
54550
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+617 3163 2701
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Email
54550
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[email protected]
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Contact person for public queries
Name
54551
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Georgie Cupples
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Address
54551
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Mater Misericordiae Ltd Raymond Terrace South Brisbane QLD 4101
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Country
54551
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Australia
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Phone
54551
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+617 3163 3884
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Fax
54551
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+617 3163 1588
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Email
54551
0
[email protected]
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Contact person for scientific queries
Name
54552
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Janet R Hardy
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Address
54552
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Director of Palliative Care Mater Misericordiae Ltd Raymond Terrace South Brisbane QLD 4101
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Country
54552
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Australia
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Phone
54552
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+617 3163 2775
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Fax
54552
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+617 3163 2701
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Email
54552
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
504O Effects of steroid ointment application on chemotherapy-induced phlebitis: A randomized, double-blind, placebo-controlled clinical trial
2017
https://doi.org/10.1093/annonc/mdx676.003
Dimensions AI
505P A randomised, controlled, double blind study of oral methotrimeprazine versus oral haloperidol in patients with cancer and nausea not related to anticancer therapy
2017
https://doi.org/10.1093/annonc/mdx676.004
Dimensions AI
506P A framework for education and advocacy for optimal cancer pain management in resource-limited settings
2017
https://doi.org/10.1093/annonc/mdx676.005
Embase
Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: A randomised, double-blind controlled trial.
2019
https://dx.doi.org/10.1136/bmjopen-2019-029942
N.B. These documents automatically identified may not have been verified by the study sponsor.
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