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

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

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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: XP19986 SR3, 20 mg QD
* Drug: XP19986 SR3, 40 mg QD
* Drug: XP19986 SR3, 60 mg QD
* Drug: XP19986 SR3, 30 mg BID
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XP19986 SR3, 20 mg QD<br>XP19986, 20 mg QD for approximately 32 days | Drug: XP19986 SR3, 20 mg QD<br>* XP19986 Sustained Release (SR) 20 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.<br>* Other names: arbaclofen placarbil;|
| Experimental: XP19986 SR3, 40 mg QD<br>XP19986, 40 mg QD for approximately 32 days | Drug: XP19986 SR3, 40 mg QD<br>* XP19986 Sustained Release (SR) 40 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.<br>* Other names: arbaclofen placarbil;|
| Experimental: XP19986 SR3, 60 mg QD<br>XP19986, 60 mg QD for approximately 32 days | Drug: XP19986 SR3, 60 mg QD<br>* XP19986 Sustained Release (SR) 60 mg tablet taken orally, once daily (QD) for approximately 32 days with titration and taper periods.<br>* Other names: arbaclofen placarbil;|
| Experimental: XP19986 SR3, 30 mg BID<br>XP19986, 30 mg BID for approximately 32 days | Drug: XP19986 SR3, 30 mg BID<br>* XP19986 Sustained Release (SR) 30 mg tablet taken orally, twice daily (BID) for approximately 32 days with titration and taper periods.<br>* Other names: arbaclofen placarbil;|
| Placebo Comparator: Placebo<br>Placebo for approximately 32 days | Drug: Placebo<br>* Placebo tablet taken orally for approximately 32 days with titration and taper periods.<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of heartburn events over the treatment period |  | 4-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms |  | 4-weeks |