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

XenoPort, Inc.156 enrolled

Overview

To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

156

Conditions

Gastroesophageal Reflux

Interventions

XP19986 SR3, 20 mg QDDRUG

XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.

XP19986 SR3, 40 mg QDDRUG

XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.

XP19986 SR3, 60 mg QDDRUG

XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

MDS Pharma Services

Irvine, California, United States

Outcomes

Primary Outcomes

Number of heartburn events over the treatment period

Time frame: 4-weeks

Secondary Outcomes

Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms

Time frame: 4-weeks

Data from ClinicalTrials.gov

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