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NCT00557401 Clinical Trial

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

Gastroesophageal Reflux Clinical Trial

Official title:
A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00557401
Other study ID # XP-B-057
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2007
Est. completion date September 2008

Study information
Verified date February 2021
Source XenoPort, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• XP19986 SR3, 20 mg QD
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 QD
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 QD
XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.
• XP19986 SR3, 30 mg BID
XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.
• Placebo
Placebo tablet taken orally for approximately 32 days with titration and taper periods.

Locations
Country Name City State
United States MDS Pharma Services Irvine California

Sponsors (1)
Lead Sponsor Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of heartburn events over the treatment period 4-weeks
Secondary Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms 4-weeks
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