An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

Phase 2 Terminated 67 enrolled Shire

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this trial is to investigate the pharmacodynamic effect on reflux parameters of SPD557 tablets (0.5 mg t.i.d., on top of PPI treatment) in patients with Gastroesophageal Reflux Disease (GERD) with persistent symptoms despite taking a stable dose of proton pump inhibitors. Additionally the effect on symptoms will be explored and safety and tolerability will be evaluated.

Timeline

Start: 2010-12-02
Primary completion: 2012-05-29
Completion: 2012-05-29

Outcome

Missed primary endpoint

Stopped (Enrollment): “This study was terminated early due to recruitment difficulties. There were no safety concerns.”

registry analysis (unspecified test); SPD557 vs Placebo; p = 0.869; Difference in LS Mean -1.452 (95% CI -19.054 to 16.149); ANCOVA NCT01370863 ↗

Publications

Tack J, Zerbib F, Blondeau K, des Varannes SB, Piessevaux H, Borovicka J, Mion F, Fox M, Bredenoord AJ, Louis H, Dedrie S, Hoppenbrouwers M, Meulemans A, Rykx A, Thielemans L, Ruth M. Randomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment. Neurogastroenterol Motil. 2015 Feb;27(2):258-68. doi: 10.1111/nmo.12484. Epub 2014 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	revexepride	Unknown	0.5 mg	—