Overview

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)