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

Timeline

Start

2006-10

Primary completion

—

Completion

2007-05

Outcome

Met primary endpoint

paper Patients receiving velusetrag (15, 30 and 50 mg) achieved statistically and clinically significant increases in weekly SBM frequency relative to those receiving placebo. PMID 21039672 ↗

paper Mean increases were 3.6, 3.3 and 3.5 SBM/week respectively, compared with 1.4 SBM/week for placebo (P < 0.0001). PMID 21039672 ↗

Publications

• Goldberg M, Li YP, Johanson JF, Mangel AW, Kitt M, Beattie DT, Kersey K, Daniels O. Clinical trial: the efficacy and tolerability of velusetrag, a selective 5-HT4 agonist with high intrinsic activity, in chronic idiopathic constipation - a 4-week, randomized, double-blind, placebo-controlled, dose-response study. Aliment Pharmacol Ther. 2010 Nov;32(9):1102-12. doi: 10.1111/j.1365-2036.2010.04456.x. Epub 2010 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Velusetrag	Small molecule	15 mg	Oral
Subject	Velusetrag	Small molecule	30 mg	Oral
Subject	Velusetrag	Small molecule	50 mg	Oral

Indications