Overview

An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD

Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
0
Participant gender:
All
Summary
To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indivior Inc.
XenoPort, Inc.
Treatments:
Arbaclofen placarbil
Baclofen
Criteria
Inclusion Criteria:

- History and documentation of GERD diagnosed by a gastroenterologist, with symptoms
(heartburn and/or regurgitation) on ≥ 3 days during the week prior to screening and
prior to randomization

Exclusion Criteria:

- Current or historical endoscopic evidence of erosive esophagitis LA Classification
Grade B, C, or D