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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00557401
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

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

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Study of XP19986 in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Study Start Date : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Sugar Pill




Primary Outcome Measures :
  1. Number of heartburn events over the treatment period [ Time Frame: 4-weeks ]

Secondary Outcome Measures :
  1. Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms [ Time Frame: 4-weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557401


Locations
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United States, California
MDS Pharma Services
Irvine, California, United States, 92618
Sponsors and Collaborators
Indivior Inc.
Investigators
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Study Director: Jay Huff, M.D. XenoPort, Inc.
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Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00557401    
Other Study ID Numbers: XP-B-057
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Arbaclofen placarbil
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action