A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and
Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation
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Full eligibility criteria for NCT01459926
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
- History of constipation with onset after initiation of opioid therapy
- Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or
less for each week over at least the previous two week period
- Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units
(MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have
used a stable daily regimen of opioids for at least the 2 weeks preceding the
- Willing to stop all laxatives and other bowel regimens with the exception of
bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation,
treatment, and follow-up periods
- Have participated in a clinical trial of an investigational drug or medical device
within 30 days prior to Screening
- Have any condition that may affect drug absorption, (e.g., previous GI surgery)
- Any other condition which, in the opinion of the investigator, could confound or
interfere with evaluation of safety or tolerability of the investigational drug, or
prevent compliance with the study protocol
All locations for NCT01459926
United States (1)
G and L Research, LLC
Foley, Alabama, United States, 36535
View full eligibility
Tris trial is registered with FDA with number: NCT01459926. The sponsor of the trial is Theravance Biopharma and it is looking for 217 volunteers for the current phase.
Official trial title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
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