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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT01459926
First received: October 24, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Opioid Induced Constipation
Drug: TD-1211
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment [ Time Frame: Between weeks 2 and 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the weekly SBM frequency in the last week of treatment [ Time Frame: baseline and 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 Drug: TD-1211
once daily
Experimental: Dose 2 Drug: TD-1211
Once daily
Experimental: Dose 3 Drug: TD-1211
Once daily
Experimental: Placebo Drug: Placebo
Once daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459926

Locations
United States, Alabama
G and L Research, LLC
Foley, Alabama, United States, 36535
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Daniel M. Canafax, Pharm.D., FCCP Theravance Biopharma Antibiotics, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier: NCT01459926     History of Changes
Other Study ID Numbers: 0084
Study First Received: October 24, 2011
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Opioid induced constipation
OIC
Constipation
Opioid side effects
Morphine induced constipation
Opioid therapy

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014