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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03252353




Registration number
NCT03252353
Ethics application status
Date submitted
10/08/2017
Date registered
17/08/2017

Titles & IDs
Public title
Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands (SRL) Treatment
Secondary ID [1] 0 0
OOC-ACM-303
Universal Trial Number (UTN)
Trial acronym
OPTIMAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - octreotide capsules
Treatment: Drugs - Matching placebo

Active comparator: Octreotide capsules - Octreotide capsules

Placebo comparator: Matching Placebo - Matching placebo capsules


Treatment: Drugs: octreotide capsules
octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)

Treatment: Drugs: Matching placebo
Matching placebo capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.
Timepoint [1] 0 0
Week 36
Secondary outcome [1] 0 0
Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period
Timepoint [1] 0 0
Week 36
Secondary outcome [2] 0 0
Number of Patients Who Begin Rescue Treatment
Timepoint [2] 0 0
Week 36

Eligibility
Key inclusion criteria
* Documented evidence of active acromegaly
* Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy
* Biochemically controlled
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label
* Pituitary surgery within six months
* Conventional or stereotactic pituitary radiotherapy any time in the past
* Patients who previously participated in CH-ACM-01 or OOC-ACM-302
* Any clinically significant uncontrolled concomitant disease
* Symptomatic cholelithiasis
* Pegvisomant, within 24 weeks
* Dopamine agonists, within 12 weeks
* Pasireotide, within 24 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Private Hospital-NSW - Darlinghurst
Recruitment hospital [2] 0 0
Royal North Shore Public Hospital - St Leonards
Recruitment hospital [3] 0 0
St Vincent's Hospital-VIC - Fitzroy
Recruitment hospital [4] 0 0
The Alfred - Melbourne
Recruitment hospital [5] 0 0
Melbourne Health - Parkville
Recruitment hospital [6] 0 0
Keogh Institute (Sir Charles Gardner) - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
State/province [5] 0 0
Maryland
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United States of America
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Massachusetts
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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Bulgaria
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Sofia
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Germany
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Aachen
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Germany
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Munich
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Hungary
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Budapest
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Hungary
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Szeged
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Italy
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Monserrato
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Italy
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Pisa
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Latvia
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Riga
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Netherlands
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Leiden
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Netherlands
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Rotterdam
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New Zealand
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Dunedin
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New Zealand
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Wellington
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Warszawa
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Poland
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Wroclaw
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Slovenia
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Ljubljana
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Sweden
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Göteborg
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Turkey
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Ankara
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Turkey
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Izmir
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Turkey
State/province [43] 0 0
Kayseri
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United Kingdom
State/province [44] 0 0
Birmingham
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United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chiasma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Susan L Samson, MD PhD
Address 0 0
Pituitary Center at Baylor St. Luke's Medical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03252353