A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Eff… (NCT01459926) | Clinical Trial Compass
CompletedPhase 2
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
United States217 participantsStarted 2011-11
Plain-language summary
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Screening Visit
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment