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

Opioid Induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459926
• Other study ID #: 0084
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid Induced Constipation

Intervention

Drug:
• TD-1211
once daily
• TD-1211
Once daily
• TD-1211
Once daily
• Placebo
Once daily

Locations

Country	Name	City	State
United States	G and L Research, LLC	Foley	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment		Between weeks 2 and 5
Secondary	Change from baseline in the weekly SBM frequency in the last week of treatment		baseline and 5 weeks