Conditions: Opioid-Induced Constipation
Keywords: opioid-induced constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 237
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Methylnaltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: