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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2011-09-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid-Induced Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MNTX 150 mg

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).

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

MNTX 300 mg

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).

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

MNTX 450 mg

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).

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Methylnaltrexone

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Relistor

Eligibility Criteria

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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..

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No