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

Phase 2

Completed

• Conditions: Chronic Constipation

• Registration Number: NCT00391820
• Lead Sponsor: Alfasigma S.p.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-01
• Study First Submitted: 2006-10-20
• Study First Submitted QC: 2006-10-20
• Study First Posted: 2006-10-24
• Study Completion: 2007-05-01
• Status Verified: 2014-12
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
- Clinical response

Trial Locations

Locations (1)

Breco Research; 🇺🇸 Houston, Texas, United States