Conditions: Opioid-Induced Constipation
Keywords: Opioid-Induced Constipation
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 156
Healthy volunteers: no

Brief summary:
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

Detailed description:

Arms:
arm 1: Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.

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.

Interventions: intervention 1: Methylnaltrexone bromide
Intervention descriptions: intervention 1: None

Protocol document: