A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theravance Biopharma; Theravance Biopharma R & D, Inc.
• Treatments: Analgesics, Opioid

Criteria

Inclusion Criteria:

• Males and females between 18 and 65 years of age, inclusive

• Subjects with documented OIC on stable opioid regimen

• Willingness to stop all laxatives throughout run-in and treatment period

Exclusion Criteria:

• Any clinically significant findings in subjects with OIC

• Have participated in another clinical trial of an investigational drug 30 days prior to screening

• History of chronic constipation prior to opioid therapy in OIC subjects

• Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects