A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT01401985
First received: July 19, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-Blind, Pilot Study to Determine the Tolerability and Safety 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:
  • Safety and tolerability of TD-1211 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Safety and tolerability of TD-1211


Secondary Outcome Measures:
  • Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM) [ Time Frame: Weekly assessments throughout Treatment Period ] [ Designated as safety issue: No ]
    Change from baseline in the weekly SBM and CSBM frequency


Enrollment: 95
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TD-1211
TD-1211
Drug: TD-1211
Capsules once daily

  Eligibility

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  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: NCT01401985

Locations
United States, California
Pasadena, California, United States
Sponsors and Collaborators
Theravance Biopharma Antibiotics, 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.
ClinicalTrials.gov Identifier: NCT01401985     History of Changes
Other Study ID Numbers: TD-1211-0076
Study First Received: July 19, 2011
Last Updated: June 5, 2013
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

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014