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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557401

Enrollment

156

Registered

2007-11-14

Start date

2007-11-30

Completion date

2008-09-30

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Brief summary

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

Interventions

DRUGXP19986 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.

DRUGXP19986 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.

DRUGXP19986 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.

DRUGXP19986 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.

DRUGPlacebo

Placebo tablet taken orally for approximately 32 days with titration and taper periods.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of heartburn events over the treatment period	4-weeks

Secondary

Measure	Time frame
Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms	4-weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026