An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
Phase 2
Completed
- Conditions
- Gastroesophageal Reflux
- Interventions
- Registration Number
- NCT00557401
- Lead Sponsor
- XenoPort, Inc.
- Brief Summary
To evaluate efficacy and safety of treatment with XP19986 Sustained Release (SR) Tablet compared to placebo in subjects with symptomatic GERD
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description XP19986 SR3, 40 mg QD XP19986 SR3, 40 mg QD XP19986, 40 mg QD for approximately 32 days XP19986 SR3, 60 mg QD XP19986 SR3, 60 mg QD XP19986, 60 mg QD for approximately 32 days XP19986 SR3, 30 mg BID XP19986 SR3, 30 mg BID XP19986, 30 mg BID for approximately 32 days Placebo Placebo Placebo for approximately 32 days XP19986 SR3, 20 mg QD XP19986 SR3, 20 mg QD XP19986, 20 mg QD for approximately 32 days
- Primary Outcome Measures
Name Time Method Number of heartburn events over the treatment period 4-weeks
- Secondary Outcome Measures
Name Time Method Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms 4-weeks
Trial Locations
- Locations (1)
MDS Pharma Services
🇺🇸Irvine, California, United States