Back to resultsA Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
Primary Purpose
Opioid-induced Constipation (OIC)
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 (OIC) focused on measuring constipation, opioid induced
Eligibility Criteria
Inclusion Criteria:
- Males and females between 18 and 65 years of age, inclusive
- Subjects with documented OIC on stable opioid regimen
- Willingness to stop all laxatives throughout run-in and treatment period
Exclusion Criteria:
- Any clinically significant findings in subjects with OIC
- Have participated in another clinical trial of an investigational drug 30 days prior to screening
- History of chronic constipation prior to opioid therapy in OIC subjects
- Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
Sites / Locations
- Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Escalating Doses of TD-1211
Outcomes
Primary Outcome Measures
Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211
Secondary Outcome Measures
Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01333540
Brief Title
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Clinical Activity 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
May 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 dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients 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 (OIC)
Keywords
constipation, opioid induced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Escalating Doses of TD-1211
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TD-1211
Intervention Description
Escalating doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Frequency and Severity of Treatment Emergent Adverse Events in Subjects with Opioid-Induced Constipation Treated with TD-1211
Time Frame
Daily doses, safety assessments and activity of TD-1211 as compared to placebo for up to six weeks
Secondary Outcome Measure Information:
Title
Evaluation of clinical activity measured as frequency of bowel-movements at different dose levels
Time Frame
Continuous assessments for up to six 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:
Males and females between 18 and 65 years of age, inclusive
Subjects with documented OIC on stable opioid regimen
Willingness to stop all laxatives throughout run-in and treatment period
Exclusion Criteria:
Any clinically significant findings in subjects with OIC
Have participated in another clinical trial of an investigational drug 30 days prior to screening
History of chronic constipation prior to opioid therapy in OIC subjects
Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
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
Clinical Research Unit
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
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