Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Post-Operative Ileus (POI)

Treatments: Drug: Methylnaltrexone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401375

MNTX 3301

Details and patient eligibility

About

To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.

Enrollment: 524 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants at least 18 years of age.
• All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
• Participants must sign an informed consent form (ICF).
• Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
• Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
• Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.

Exclusion criteria

• Participants who received any investigational new drug in the 30 days prior to screening visit.
• Females who are pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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524 participants in 3 patient groups, including a placebo group

MNTX 12 mg

Experimental group

Description:

Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).

Treatment:

Drug: Methylnaltrexone

MNTX 24 mg

Experimental group

Description:

Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).

Treatment:

Drug: Methylnaltrexone

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).

Treatment:

Drug: Placebo