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

Alfasigma

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation

Treatments: Drug: TD-5108

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391820

0038

Details and patient eligibility

About

Study 0038 compares the safety and effectiveness of an investigational drug, TD-5108 with placebo (a sugar pill) for the treatment of chronic constipation.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind