A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

Study Overview
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Brief Summary
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A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation

Official Title
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A Single-Blind, Pilot Study to Determine the Tolerability and Safety 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: Placebo


Participation Criteria
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Eligibility Criteria
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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)

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days | Drug: TD-1211<br>* Capsules<br>|
| Experimental: Cohort 2<br>5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days | Drug: TD-1211<br>* Capsules<br>|
| Experimental: Cohort 3<br>5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days | Drug: TD-1211<br>* Capsules<br>|
| Experimental: Cohort 4<br>5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days | Drug: TD-1211<br>* Capsules<br>|
| Experimental: Cohort 5<br>2 mg TD-1211 once daily for 14 days | Drug: TD-1211<br>* Capsules<br>Drug: Placebo<br>* Capsules<br>|
| Experimental: Cohort 6<br>2.5 mg TD-1211 every 6 hours for 14 days | Drug: TD-1211<br>* Capsules<br>Drug: Placebo<br>* Capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of TD-1211 |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM) | Change from baseline in the weekly SBM and CSBM frequency | Weekly assessments throughout Treatment Period | 

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