A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

Bausch Health

Status and phase: Completed; Phase 3

Conditions: Advanced Illness Patients With Opioid Induced Constipation

Treatments: Drug: SC Placebo; Drug: SC Methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401362

MNTX 301

Details and patient eligibility

About

To test the effectiveness of MNTX in advanced illness subjects.

Full description

To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Advanced medical illness with a life expectancy of 1 to 6 months
2. No clinically significant laxation within 48 hours prior to the first dose of study drug
3. On stable opioid and laxative regimen for a least 3 days prior to treatment
4. Age greater than 18years
5. Females of child-bearing age must have a negative pregnancy test.

Exclusion criteria

1. Females who are pregnant or nursing.
2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
3. Any disease process suggestive of gastrointestinal obstruction
4. Fecal ostomy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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154 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: SC Methylnaltrexone

Drug: SC Methylnaltrexone

Arm 3

Placebo Comparator group

Treatment:

Drug: SC Placebo

Arm 2

Experimental group

Treatment:

Drug: SC Methylnaltrexone

Drug: SC Methylnaltrexone