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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
4/09/2019

Titles & IDs
Public title
A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants 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
Treatment: Drugs - Placebo

Experimental: MOA-728 12 mg - Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.

Experimental: MOA-728 24 mg - Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.

Placebo Comparator: Placebo - Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.


Treatment: Drugs: MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.

Treatment: Drugs: Placebo
Placebo matching to MOA-728 will be administered per the schedule specified in the arm.

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

Outcomes
Primary outcome [1] 0 0
Time to First Bowel Movement - Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
Timepoint [1] 0 0
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary outcome [1] 0 0
Time to Discharge Eligibility - Time to discharge eligibility was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Discharge eligibility was defined as tolerance of oral intake of liquids greater than (>) 500 milliliters (mL) per 8 hours without nausea or retching/vomiting. Analysis was performed by Kaplan-Meier estimate.
Timepoint [1] 0 0
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary outcome [2] 0 0
Time to Discharge Order Written From the End of Surgery - The investigator or designee recorded the time of the order. Participants re-admitted to the hospital with a diagnosis of POI within 7 days after discharge was considered treatment failures. Analysis was performed by Kaplan-Meier estimate.
Timepoint [2] 0 0
Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Secondary outcome [3] 0 0
Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at Day 2 (24 Hours) as Evaluated by the Opioid-Related Symptom Distress Scale (SDS) - CMEs were defined using opioid-related SDS (assessed participant-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe (3) or very severe (4), with the exception of confusion. A total CME score was calculated by summing the number of CMEs across symptoms and ranged from 0 to 9. CME was counted for either nausea or vomiting/retching, or both and reported in this outcome measure.
Timepoint [3] 0 0
Day 2

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 glomerular filtration rate [GFR]
formula) less than or equal to (</=) 50 milliliters/minute (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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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
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
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United States of America
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Arkansas
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California
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Massachusetts
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Wisconsin
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Belgium
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Edegem
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Gent Belgium
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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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Heidelberg
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Pecs
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Ferrara
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Rome
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Via Giustiniani 2
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Bergamo
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Pretoria Gauteng
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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
This study will evaluate the safety and efficacy of two different dose regimens (12
milligrams [mg] and 24 mg) of IV MOA-728 versus placebo in shortening the time to return of
bowel function in participants receiving opioid analgesia administered via patient-controlled
anesthesia (PCA), and who had undergone repair of large (greater than or equal to [=]10
centimeters) ventral hernias with or without a mesh prosthesis via laparotomy or laparoscopy.
Trial website
https://clinicaltrials.gov/show/NCT00528970
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lindsey Mathew
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