Back to resultsA Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Primary Purpose
Opioid Induced Constipation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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
Eligibility Criteria
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)
Sites / Locations
- Theravance Biopharma Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Cohort 6
Arm Description
5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
2 mg TD-1211 once daily for 14 days
2.5 mg TD-1211 every 6 hours for 14 days
Outcomes
Primary Outcome Measures
Safety and tolerability of TD-1211
Secondary Outcome Measures
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
Change from baseline in the weekly SBM and CSBM frequency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01401985
Brief Title
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
Official Title
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 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 Single-Blind, Pilot Study to Determine the Tolerability and Safety 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
2 mg TD-1211 once daily for 14 days
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
2.5 mg TD-1211 every 6 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
Safety and tolerability of TD-1211
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
Description
Change from baseline in the weekly SBM and CSBM frequency
Time Frame
Weekly assessments throughout Treatment Period
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:
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)
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
Theravance Biopharma Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Learn more about this trial
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
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