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NCT00391820 Clinical Trial

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

Chronic Constipation Clinical Trial

Official title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of TD-5108 for the Treatment of Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00391820
Other study ID # 0038
Secondary ID
Status Completed
Phase Phase 2
First received October 20, 2006
Last updated December 1, 2014
Start date October 2006
Est. completion date May 2007

Study information
Verified date December 2014
Source Theravance Biopharma R & D, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 360
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• TD-5108

Locations
Country Name City State
United States Breco Research Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Theravance Biopharma R & D, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary - Clinical response
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