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

February 17, 2021 updated by: XenoPort, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • MDS Pharma Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XP19986 SR3, 20 mg QD
XP19986, 20 mg QD for approximately 32 days
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.
Other Names:
  • arbaclofen placarbil
Experimental: XP19986 SR3, 40 mg QD
XP19986, 40 mg QD for approximately 32 days
Drug: 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.
Other Names:
  • arbaclofen placarbil
Experimental: XP19986 SR3, 60 mg QD
XP19986, 60 mg QD for approximately 32 days
Drug: 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.
Other Names:
  • arbaclofen placarbil
Experimental: XP19986 SR3, 30 mg BID
XP19986, 30 mg BID for approximately 32 days
Drug: 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.
Other Names:
  • arbaclofen placarbil
Placebo Comparator: Placebo
Placebo for approximately 32 days
Drug: Placebo
Placebo tablet taken orally for approximately 32 days with titration and taper periods.
Other Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XenoPort, Inc.

Investigators

  • Study Director: Jay Huff, M.D., XenoPort, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 12, 2007

First Submitted That Met QC Criteria

November 12, 2007

First Posted (Estimate)

November 14, 2007

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XP-B-057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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