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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01186770
Other study ID # MNTX 3201
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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