Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00387309




Registration number
NCT00387309
Ethics application status
Date submitted
11/10/2006
Date registered
13/10/2006
Date last updated
25/11/2019

Titles & IDs
Public title
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.
Secondary ID [1] 0 0
3200L2-300
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Operative Bowel Dysfunction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the MOA-728 regimen than with a placebo regimen.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion:

* Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia
* Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met
* Subjects must meet the American Society of Anesthesiologists physical status I, II or III
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

* Subjects who are scheduled for laparoscopic surgery for the segmental colectomy
* Subjects with a recent history (<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)
* Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Elizabeth Vale
Recruitment hospital [3] 0 0
- Woodville South
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 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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District of Columbia
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United States of America
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Florida
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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
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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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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Minnesota
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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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North Carolina
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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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Oklahoma
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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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Rhode Island
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United States of America
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Tennessee
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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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Virginia
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Former Serbia and Montenegro
State/province [25] 0 0
Beograd
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Germany
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Berlin
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Munchen
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Hungary
State/province [30] 0 0
Budapest
Country [31] 0 0
Hungary
State/province [31] 0 0
Gyor
Country [32] 0 0
Hungary
State/province [32] 0 0
Pecs
Country [33] 0 0
Hungary
State/province [33] 0 0
Szekesfehervar
Country [34] 0 0
Italy
State/province [34] 0 0
Zingonia
Country [35] 0 0
Italy
State/province [35] 0 0
Bologna
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Italy
State/province [36] 0 0
Ferrara
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Italy
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Genova
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Italy
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Monza
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Italy
State/province [39] 0 0
Padova
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Italy
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Roma
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Korea, Republic of
State/province [41] 0 0
Seoul
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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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Lodz
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Poland
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Poznan
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Romania
State/province [46] 0 0
Bucharest
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South Africa
State/province [47] 0 0
Gauteng
Country [48] 0 0
South Africa
State/province [48] 0 0
Kwa-Zulu Natal
Country [49] 0 0
South Africa
State/province [49] 0 0
Western Cape

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bausch Health Americas, 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
Jeff Cohn
Address 0 0
Bausch Health Americas, Inc.
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00387309