CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 288 enrolled
Drug / intervention
E3810 +2 moredrug
Likely dose
E3810 5 mg once daily orally for 4 weeks OR E3810 10 mg once daily orally for 4 weeksAI-extracted
Key inclusion· 7
  • ✓Heartburn ≥2 days/week for consecutive weeks during 3 weeks prior to pre-observation screening, with continuous presence if screening and registration dates differ
  • ✓Symptom is burning sensation from stomach or lower chest, appearing frequently or aggravated after eating, bending forward, or abdominal pressure
  • ✓Grade M (minimal change/discoloring type) esophagitis per Los Angeles System (2nd Modification)
  • ✓Age ≥20 years at consent
Key exclusion· 18
  • ✕Unable to maintain adequate heartburn diary entries
  • ✕Significant complaints of heavy stomach sensation or abdominal bloating
  • ✕History or current psychiatric/psychosomatic disease (e.g., manic-depressive psychosis, obsessive-compulsive neurosis), or use of antidepressant/anti-anxiety agents (except hypnotics)
  • ✕H. pylori eradication therapy <6 months prior to observation period start

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00165646
NCT00165646Phase 3Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled, Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease

Eisai Co., Ltd.·interventional·Posted Sep 14, 2005·Updated Jul 18, 2011

In Brief

A Phase 3 clinical trial evaluating E3810 and Placebo for Non-erosive Gastroesophageal Reflux Disease. Completed, enrolled 288 participants across 35 sites.

Detailed Summary

To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-erosive Gastroesophageal Reflux Disease
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartSep 1, 2004
Primary CompletionOct 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

E3810drug

E3810 5mg: once daily orally for 4 weeks

E3810drug

E3810 10mg: once daily orally for 4 weeks

Placebodrug

Placebo: once daily orally for 4 weeks