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

This study has been completed.
Sponsor:
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00557401
First received: November 12, 2007
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux
Drug: XP19986, 20 mg QD
Drug: XP19986, 40 mg QD
Drug: XP19986, 60 mg QD
Drug: XP19986, 30 mg BID
Drug: XP19986 Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by XenoPort, Inc.:

Primary Outcome Measures:
  • Number of heartburn events over the treatment period [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms [ Time Frame: 4-weeks ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: December 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: XP19986, 20 mg QD
After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
Experimental: 2 Drug: XP19986, 40 mg QD
After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
Experimental: 3 Drug: XP19986, 60 mg QD
After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
Experimental: 4 Drug: XP19986, 30 mg BID
After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods
Experimental: 5 Drug: XP19986 Placebo
After the washout period, subjects will be randomized to receive placebo or XP19986 SR study treatments. XP19986 Sustained Release (SR) Tablet will be dosed orally, QD or BID, for approximately 32 days with titration and taper periods

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557401

Locations
United States, California
MDS Pharma Services
Irvine, California, United States, 92618
Sponsors and Collaborators
XenoPort, Inc.
Investigators
Study Director: Jay Huff, M.D. XenoPort, Inc.
  More Information

No publications provided

Responsible Party: Jay Huff, VP Clinical Development, XenoPort Inc
ClinicalTrials.gov Identifier: NCT00557401     History of Changes
Other Study ID Numbers: XP-B-057
Study First Received: November 12, 2007
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 26, 2014