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

This study has been completed.
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier:
First received: October 20, 2006
Last updated: December 1, 2014
Last verified: December 2014
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00391820

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 
Study First Received: October 20, 2006
Last Updated: December 1, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 26, 2016