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Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00391820
First Posted: October 24, 2006
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
  Purpose
Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.

Condition Intervention Phase
Chronic Constipation Drug: TD-5108 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma R & D, Inc.:

Primary Outcome Measures:
  • - Clinical response

Estimated Enrollment: 360
Study Start Date: October 2006
Study Completion Date: May 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet ROME III Criteria

Exclusion Criteria:

  • Constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function
  • Chronic treatment with anticholinergics, narcotic analgesics
  • Irritable Bowel Syndrome
  Contacts and Locations
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): NCT00391820


Locations
United States, Texas
Breco Research
Houston, Texas, United States, 77024
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT00391820     History of Changes
Other Study ID Numbers: 0038
First Submitted: October 20, 2006
First Posted: October 24, 2006
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Theravance Biopharma R & D, Inc.:
constipation
chronic
bowel function

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