A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
Primary Purpose
Opioid Induced Constipation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TD-1211
TD-1211
TD-1211
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Induced Constipation focused on measuring Opioid induced constipation, OIC, Constipation, Opioid side effects, Morphine induced constipation, Opioid therapy
Eligibility Criteria
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
Sites / Locations
- G and L Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose 1
Dose 2
Dose 3
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
Secondary Outcome Measures
Change from baseline in the weekly SBM frequency in the last week of treatment
Full Information
NCT ID
NCT01459926
First Posted
October 24, 2011
Last Updated
January 19, 2021
Sponsor
Theravance Biopharma
1. Study Identification
Unique Protocol Identification Number
NCT01459926
Brief 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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Induced Constipation
Keywords
Opioid induced constipation, OIC, Constipation, Opioid side effects, Morphine induced constipation, Opioid therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1
Arm Type
Experimental
Arm Title
Dose 2
Arm Type
Experimental
Arm Title
Dose 3
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
Time Frame
Between weeks 2 and 5
Secondary Outcome Measure Information:
Title
Change from baseline in the weekly SBM frequency in the last week of treatment
Time Frame
baseline and 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
G and L Research, LLC
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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