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

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ClinicalTrials.gov Identifier: NCT00391820
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Constipation Drug: TD-5108 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
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
Study Start Date : October 2006
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Primary Outcome Measures :
  1. - Clinical response

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

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

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

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

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 Posted: October 24, 2006    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

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

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