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

This study has been completed.

Sponsored by:	Theravance
Information provided by:	Theravance
ClinicalTrials.gov Identifier:	NCT00391820

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 II

MedlinePlus related topics: Constipation

Drug Information available for: Serotonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation

Further study details as provided by Theravance:

Primary Outcome Measures:

- Clinical response

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

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391820

Locations

United States, Texas
Breco Research
Houston, Texas, United States, 77024

Sponsors and Collaborators

Theravance

More Information

Study ID Numbers:	0038
Study First Received:	October 20, 2006
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00391820
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theravance:

constipation
chronic
bowel function

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Serotonin

ClinicalTrials.gov processed this record on January 15, 2009