A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects 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:

• stable dose of opioids for at least 12 weeks before screening visit

• less than or equal to 5 spontaneous bowel movements for a 2 week period and experiencing at least one other symptom of constipation

• willing to stop laxatives and other bowel treatments; rescue laxative allowed

Exclusion Criteria:

• Clinically significant condition or illness (other than the condition for which the pain medication was prescribed)

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

• History of cancer treatment except adequately treated localized skin cancer within 5 years of screening

• History of chronic constipation prior to opioid therapy

• Females who are pregnant or breast feeding

• Have any condition that may affect drug absorption (e.g. previous GI surgery)