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

This study has been completed.
Sponsor:
Information provided by:
Theravance Biopharma Antibiotics, Inc.
ClinicalTrials.gov Identifier:
NCT00391820
First received: October 20, 2006
Last updated: August 17, 2010
Last verified: August 2010
  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
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 Antibiotics, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Biopharma Antibiotics, Inc.
  More Information

No publications provided by Theravance Biopharma Antibiotics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00391820     History of Changes
Other Study ID Numbers: 0038
Study First Received: October 20, 2006
Last Updated: August 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
constipation
chronic
bowel function

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014