An Efficacy and Safety Study of XP19986 in Subjects With Symptomatic GERD
This study has been completed.
Sponsor:
XenoPort, Inc.
Information provided by:
XenoPort, Inc.
ClinicalTrials.gov Identifier:
NCT00557401
First received: November 12, 2007
Last updated: September 10, 2010
Last verified: September 2010
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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 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 May 19, 2013