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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00528970




Registration number
NCT00528970
Ethics application status
Date submitted
11/09/2007
Date registered
14/09/2007
Date last updated
28/07/2011

Titles & IDs
Public title
A Study Evaluating IV MOA-728 for the Treatment of POI In Subjects After Ventral Hernia Repair
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus After Ventral Hernia Repair
Secondary ID [1] 0 0
3200L2-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ileus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MOA-728
Other interventions - placebo

Placebo Comparator: 1 -

Experimental: 2 -

Experimental: 3 -


Treatment: Drugs: MOA-728


Other interventions: placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary: The effect of the interventional treatment will be measured by the time to bowel movement.
Timepoint [1] 0 0
2 weeks

Eligibility
Key inclusion criteria
- Males and females, ages 18 and older.

- Scheduled for ventral wall hernia repair with general anesthesia.

- Meets the American Society of Anesthesiologists physical status I, II, or III.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received investigational drug or procedure within 30 days of randomization.

- Women who are pregnant or lactating.

- Calculated creatinine clearance (Cockcroft-Gault GRF) </= 50 mL/min.

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
Factorial
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide SA
Recruitment hospital [2] 0 0
- Elizabeth Vale SA
Recruitment postcode(s) [1] 0 0
5006 - Adelaide SA
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale SA
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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Florida
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Illinois
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Iowa
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Kansas
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Dakota
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Tennessee
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Texas
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Virginia
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Washington
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West Virginia
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United States of America
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Wisconsin
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Belgium
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Edegem
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Belgium
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Gent Belgium
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Quebec
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Germany
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Berlin
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Germany
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Muenchen
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Germany
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Heidelberg
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Hungary
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Nyiregyhaza
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Hungary
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Pecs
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Hungary
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Szekesfehervar
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Hungary
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Veszprem
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Italy
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Ferrara
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Italy
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Rome
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Italy
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Via Giustiniani 2
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Italy
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Bergamo
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Netherlands
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Roosendaal
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Poland
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Lodz
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Poland
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Szczecin
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Poland
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Bydgoszcz
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South Africa
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Natal
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South Africa
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Western Cape
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South Africa
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Moreletapark Pretoria
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South Africa
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Pretoria Gauteng
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South Africa
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Pretoria

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bausch Health Americas, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Progenics Pharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To assess, in subjects who have ventral wall hernia repair, the time between the end of
surgery and first bowel movement with the investigational MOA-728 regimen as compared with a
placebo regimen.
Trial website
https://clinicaltrials.gov/show/NCT00528970
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

Summary results
Other publications