A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain
This study is ongoing, but not recruiting participants.
Sponsor:
Salix Pharmaceuticals
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01186770
First received: August 19, 2010
Last updated: July 15, 2011
Last verified: July 2011
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Purpose
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in order to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in subjects with chronic, non-malignant pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid-Induced Constipation |
Drug: Methylnaltrexone bromide Drug: Oral Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone (OM) for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic, Non-Malignant Pain |
Resource links provided by NLM:
Further study details as provided by Salix Pharmaceuticals:
Primary Outcome Measures:
- Proportion of subjects with rescue-free laxation [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ](1) rescue-free laxation after first dose of study drug, and (2) rescue-free laxation per subject after all doses during the first four weeks of dosing.
| Estimated Enrollment: | 700 |
| Study Start Date: | September 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Active Treatment
|
Drug: Methylnaltrexone bromide
oral tablets
|
|
Experimental: Arm 2
Active Treatment
|
Drug: Methylnaltrexone bromide
oral tablets
|
|
Experimental: Arm 3
Active Treatment
|
Drug: Methylnaltrexone bromide
oral tablets
|
|
Placebo Comparator: Arm 4
Oral Placebo
|
Drug: Oral Placebo
oral tablets
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- History of chronic non-malignant pain (originating from a non-malignant source).
- Taking oral, transdermal, intravenous, or subcutaneous opioids for chronic non-malignant pain.
- No known history of chronic constipation prior to the initiation of opioid therapy.
- Currently taking laxative therapy and willing to discontinue all laxative therapy pre-study and use only study-permitted rescue laxatives.
Key Exclusion Criteria:
- Prior treatment with oral methylnaltrexone.
- Prior treatment with SC methylnaltrexone within 30 days pre-study.
- Women who are pregnant, breastfeeding, or plan to become pregnant.
- Gastrointestinal disorders known to affect bowel transit.
- Current treatment with partial opioid agonists (e.g., buprenorphine) or combination agonists/antagonists.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186770
Locations
| United States, North Carolina | |
| PRA International | |
| Raleigh, North Carolina, United States, 27612 | |
| PRA, Intl. | |
| Raleigh, North Carolina, United States, 27612 | |
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
| Study Director: | Tage Ramakrishna, M.D. | Progenics Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Tage Ramakrishna, M.D., Vice President Clinical Research, Progenics Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01186770 History of Changes |
| Other Study ID Numbers: | MNTX 3201 |
| Study First Received: | August 19, 2010 |
| Last Updated: | July 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Salix Pharmaceuticals:
|
Treatment of Opioid-Induced Constipation in Subjects with Chronic, Non-Malignant Pain |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms Bromides Methylnaltrexone Naltrexone Analgesics, Opioid Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 22, 2013