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

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Opioid-Induced Constipation

Treatments: Drug: Placebo; Drug: Methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01186770

MNTX 3201

Details and patient eligibility

About

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.

Enrollment: 804 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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804 participants in 4 patient groups, including a placebo group

MNTX 150 mg

Experimental group

Description:

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).

Treatment:

Drug: Methylnaltrexone

Drug: Placebo

MNTX 300 mg

Experimental group

Description:

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).

Treatment:

Drug: Methylnaltrexone

Drug: Placebo

MNTX 450 mg

Experimental group

Description:

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).

Treatment:

Drug: Methylnaltrexone

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo