A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects With Opioid-Induced Constipation
1 other identifier
interventional
95
1 country
1
Brief Summary
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2011
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedMay 25, 2021
May 1, 2021
7 months
July 19, 2011
May 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of TD-1211
14 days
Secondary Outcomes (1)
Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM)
Weekly assessments throughout Treatment Period
Study Arms (6)
Cohort 1
EXPERIMENTAL5 mg TD-1211 once daily for 4 days followed by 10 mg for 14 days
Cohort 2
EXPERIMENTAL5 mg TD-1211 once daily for 4 days followed by 15 mg for 14 days
Cohort 3
EXPERIMENTAL5 mg TD-1211 once daily for 2 days followed by 10 mg for 14 days
Cohort 4
EXPERIMENTAL5 mg TD-1211 once daily for 2 days followed by 15 mg for 14 days
Cohort 5
EXPERIMENTAL2 mg TD-1211 once daily for 14 days
Cohort 6
EXPERIMENTAL2.5 mg TD-1211 every 6 hours for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Theravance Biopharma Investigational Site
Pasadena, California, 91105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Theravance Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2011
First Posted
July 26, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2012
Study Completion
August 1, 2012
Last Updated
May 25, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.