ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)

NCT00820079 ↗

Phase 2 Completed 120 enrolled Addex Pharma S.A.

RandomizedParallel-groupDouble-blindTreatment

Summary

Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.

Timeline

Start: 2008-12
Primary completion: 2009-10
Completion: —

Outcome

Met primary endpoint

paper In treatment week 2, ADX10059 significantly increased GERD symptom-free days (P=0.045) PMID 21320138 ↗

release “statistically significant efficacy on the primary endpoint, increasing the number of symptom free days in the Phase IIb trial of ADX10059 as a monotherapy” addextherapeutics.com ↗

Publications

Zerbib F, Bruley des Varannes S, Roman S, Tutuian R, Galmiche JP, Mion F, Tack J, Malfertheiner P, Keywood C. Randomised clinical trial: effects of monotherapy with ADX10059, a mGluR5 inhibitor, on symptoms and reflux events in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2011 Apr;33(8):911-21. doi: 10.1111/j.1365-2036.2011.04596.x. Epub 2011 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RASEGLURANT	Small molecule	120 mg	Oral