Study of Methylnaltrexone (MNTX) for the Relief of Constipation

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Advance Illness Patients With OIC

Treatments: Drug: SC Placebo; Drug: SC Methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402038

MNTX 302

Details and patient eligibility

About

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

Full description

This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and older
• Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
• Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
• patient must sign ICF

Exclusion criteria

• Women who are pregnant and/or nursing
• Previous treatment with MNTX
• Participation in any other studies involving investigational products within 30 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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134 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: SC Methylnaltrexone

Arm 2

Placebo Comparator group

Treatment:

Drug: SC Placebo