Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

Bausch Health

Status and phase: Completed; Phase 4

Conditions: Opioid-Induced Constipation

Treatments: Drug: Placebo; Drug: Methylnaltrexone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672477

B2541005

3200K1-4000

Details and patient eligibility

About

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is an adult 18 years of age or older
• Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
• Has a life expectancy of at least 1 month.
• Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
• Has constipation that is caused by opioid medications.

Exclusion criteria

• Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
• Has a known or suspected mechanical gastrointestinal obstruction.
• Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
• Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
• Receiving opioid antagonist or partial antagonist products.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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237 participants in 2 patient groups, including a placebo group

Methylnaltrexone

Experimental group

Description:

Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and \<62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.

Treatment:

Drug: Methylnaltrexone

Placebo

Placebo Comparator group

Description:

Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and \< 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.

Treatment:

Drug: Placebo