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

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ClinicalTrials.gov Identifier: NCT01401985
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )

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

Condition or disease Intervention/treatment Phase
Opioid Induced Constipation Drug: TD-1211 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : October 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: TD-1211
TD-1211
Drug: TD-1211
Capsules once daily



Primary Outcome Measures :
  1. Safety and tolerability of TD-1211 [ Time Frame: 14 days ]
    Safety and tolerability of TD-1211


Secondary Outcome Measures :
  1. Complete spontaneous bowel movements (CSBM); Spontaneous bowel movements (SBM) [ Time Frame: Weekly assessments throughout Treatment Period ]
    Change from baseline in the weekly SBM and CSBM frequency



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401985


Locations
United States, California
Pasadena, California, United States
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
Investigators
Study Director: Daniel M Canafax, Pharm.D., FCCP Theravance Biopharma Antibiotics, Inc.

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT01401985     History of Changes
Other Study ID Numbers: TD-1211-0076
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents