A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation

Study Overview
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Brief Summary
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A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation

Conditions
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Opioid Induced Constipation

Intervention / Treatment
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* Drug: TD-1211
* Drug: TD-1211
* Drug: TD-1211
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br> | Drug: TD-1211<br>* once daily<br>|
| Experimental: Dose 2<br> | Drug: TD-1211<br>* Once daily<br>|
| Experimental: Dose 3<br> | Drug: TD-1211<br>* Once daily<br>|
| Experimental: Placebo<br> | Drug: Placebo<br>* Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment |  | Between weeks 2 and 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the weekly SBM frequency in the last week of treatment |  | baseline and 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Morphine induced constipation, Opioid therapy, Opioid induced constipation, OIC, Opioid side effects