A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

NCT01186770 | Completed Phase 3 Results DMC

• 1 other identifier: MNTX 3201
• Study Type: interventional
• Target: 804
• Locations: 1 country
• Sites: 2

Brief Summary

MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

Conditions

Opioid-Induced Constipation

Keywords

Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain

Outcome Measures

Primary Outcomes (1)

• Average Percentage of Dosing Days That Resulted in Rescue-Free Bowel Movements (RFBMs) Within 4 Hours of Dosing During Weeks 1 to 4

  RFBM was defined as a bowel movement without laxative use within 24 hours prior to bowel movement.

  Weeks 1 to 4

Secondary Outcomes (2)

• Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4

  Weeks 1 to 4

• Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing

  Baseline, Weeks 1 to 4

Study Arms (4)

MNTX 150 mg

EXPERIMENTAL

Participants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks).

Drug: Methylnaltrexone; Drug: Placebo

MNTX 300 mg

EXPERIMENTAL

Participants will receive MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).

Drug: Methylnaltrexone; Drug: Placebo

MNTX 450 mg

EXPERIMENTAL

Participants will receive MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks).

Drug: Methylnaltrexone

Placebo

PLACEBO COMPARATOR

Participants will receive 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).

Drug: Placebo

Interventions

Methylnaltrexone DRUG

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.

Also known as: Relistor

MNTX 150 mg; MNTX 300 mg; MNTX 450 mg

Placebo DRUG

Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.

MNTX 150 mg; MNTX 300 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of chronic non-malignant pain (originating from a non-malignant source) with condition(s) underlying the chronic pain of greater than or equal to (≥) 2 months' duration before the screening visit.
• Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for ≥1 month.
• No known history of chronic constipation prior to the initiation of opioid therapy.
• Currently taking laxative therapy for ≥30 days and willing to discontinue all laxative therapy at the start of screening period and use only study-permitted rescue laxatives throughout the screening and double-blind treatment periods..

You may not qualify if:

• Prior treatment with oral MNTX.
• Prior treatment with SC MNTX within 30 days of screening.
• Women who are pregnant, breastfeeding, or plan to become pregnant during the study.
• Fecal incontinence, rectal prolapse, fecal ostomy or other clinically significant gastrointestinal disorders such as inflammatory bowel disease or clinically significant irritable bowel syndrome that would have made bowel movement assessment inaccurate.
• Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (2)

PRA International

Raleigh, North Carolina, 27612, United States

Location

PRA, Intl.

Raleigh, North Carolina, 27612, United States

Location

Related Publications (1)

• Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.

  PMID: 33788162 DERIVED

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

methylnaltrexone

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc

Lindsey.Mathew@bauschhealth.com

Study Officials

• Lindsey Mathew

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: September 1, 2010
• Primary Completion: September 8, 2011
• Study Completion: September 8, 2011
• Last Updated: September 6, 2019
• Results First Posted: September 6, 2019

Record last verified: 2019-09

Locations

US (2)