Clinical Trials Logo
  1. Home
  2. Gastroesophageal Reflux
  3. NCT00557401
  4. Details
NCT00557401 Clinical Trial

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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00557401
Other study ID # XP-B-057
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2007
Est. completion date September 2008

Study information
Verified date February 2021
Source XenoPort, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 156
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.
• 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.
• Placebo
Placebo tablet taken orally for approximately 32 days with titration and taper periods.

Locations
Country Name City State
United States MDS Pharma Services Irvine California

Sponsors (1)
Lead Sponsor Collaborator
XenoPort, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of heartburn events over the treatment period 4-weeks
Secondary Frequency of regurgitation; severity of heartburn and regurgitation; sleep symptoms 4-weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05561179 - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01946971 - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER) Phase 1/Phase 2
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00614536 - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period Phase 4
Completed NCT00373997 - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Phase 4
Completed NCT00365300 - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD) Phase 3
Completed NCT00284908 - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers Phase 1
Completed NCT01167543 - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease N/A
Completed NCT00226044 - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants. Phase 3
Completed NCT00291746 - Validation of RDQ Questionnaire Phase 4
Completed NCT00141960 - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease Phase 2/Phase 3
Completed NCT00215787 - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease N/A
Completed NCT00567021 - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms N/A
Completed NCT01048840 - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Completed NCT00181805 - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Terminated NCT01281553 - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease Phase 4
Completed NCT05486169 - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT04034017 - Gastroesophageal Reflux Disease Among College Students
Terminated NCT03226054 - Determining Risk Factors for Successful PPI Weaning N/A