A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation

Phase 2

Completed

• Conditions: Opioid Induced Constipation
• Interventions: Drug: TD-1211; Drug: Placebo

• Registration Number: NCT01459926
• Lead Sponsor: Theravance Biopharma

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Study Start: 2011-11
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Disposition First Submitted: 2013-06-05
• Disposition First Submitted QC: 2013-06-05
• Disposition First Posted: 2013-06-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 1	TD-1211	-
Dose 2	TD-1211	-
Dose 3	TD-1211	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment	Between weeks 2 and 5

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the weekly SBM frequency in the last week of treatment	baseline and 5 weeks

Trial Locations

Locations (1)

G and L Research, LLC; 🇺🇸 Foley, Alabama, United States