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
Verified date | September 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | PRA International | Raleigh | North Carolina |
United States | PRA, Intl. | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. | Progenics Pharmaceuticals, Inc. |
United States,
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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