Status:
COMPLETED
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Lead Sponsor:
Theravance Biopharma
Conditions:
Opioid Induced Constipation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01401985
Start Date
October 1 2011
End Date
August 1 2012
Last Update
May 25 2021
Active Locations (1)
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1
Theravance Biopharma Investigational Site
Pasadena, California, United States, 91105