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

Opioid-Induced Constipation Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186770
• Other study ID #: MNTX 3201
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2010
• Est. completion date: September 8, 2011

Study information

• Verified date: September 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: September 8, 2011
• Est. primary completion date: September 8, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. 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.

2. Taking oral, transdermal, intravenous (IV), or subcutaneous (SC) opioids for chronic non-malignant pain for =1 month.

3. No known history of chronic constipation prior to the initiation of opioid therapy.

4. 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..

Key Exclusion Criteria:

1. Prior treatment with oral MNTX.

2. Prior treatment with SC MNTX within 30 days of screening.

3. Women who are pregnant, breastfeeding, or plan to become pregnant during the study.

4. 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.

5. Current treatment with partial opioid agonists (for example; buprenorphine) or combination agonists/antagonists.

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• Methylnaltrexone
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
• Placebo
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.

Locations

Country	Name	City	State
United States	PRA International	Raleigh	North Carolina
United States	PRA, Intl.	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Who Responded (Responder) to Study Drug During Weeks 1 to 4	A responder was defined as at least 3 RFBMs/week, with an increase of at least 1 RFBM/week over baseline, for at least 3 out of the first 4 weeks of the treatment period. Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.	Weeks 1 to 4
Secondary	Change in Weekly Number of RFBMs From Baseline Over the Entire First 4 Weeks (28 Days) of Dosing	Weekly number of RFBMs were calculated as follows: 7 * total number of RFBMs in a week/all non-missing assessment days in the given week. Weekly number of RFBMs was set to missing for any week when a participant completed less than (<) 4 diary days in a week. A RFBM was a bowel movement without laxative use within 24 hrs prior to the bowel movement.	Baseline, Weeks 1 to 4