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A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation

2014-08-27 03:14:44 | BioPortfolio

Summary

The purpose of this study is to assess the safety and tolerability of RDC-1036 (ALKS 37) in adults with opioid-induced constipation following repeat dose administration

Description

Approximately 60 subjects will be enrolled in 1 of 2 cohorts. Following a review of Cohort 1 safety and tolerability data, subjects will then be enrolled into Cohort 2, to explore additional doses. Dose escalation will occur in both cohorts. There will be 18 visits over a 6-week period.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Opioid-induced Constipation

Intervention

RDC-1036 (ALKS 37), Placebo

Location

Alkermes Investigational Site
Pasadena
California
United States
91105

Status

Recruiting

Source

Alkermes

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:44-0400

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