A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Ileus

Treatments: Drug: Placebo; Drug: MOA-728

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528970

3200L2-301

Details and patient eligibility

About

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.

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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374 participants in 3 patient groups, including a placebo group

MOA-728 12 mg

Experimental group

Description:

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.

Treatment:

Drug: MOA-728

MOA-728 24 mg

Experimental group

Description:

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.

Treatment:

Drug: MOA-728

Placebo

Placebo Comparator group

Description:

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:

Drug: Placebo