CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
RABEPRAZOLE SODIUM +1 moredrug
Likely dose
Rabeprazole sodium 5 mg or 10 mg orally once daily for 4 weeksAI-extracted
Key inclusion· 8
  • ✓Heartburn (burning sensation from stomach/lower chest, frequent or worsened by eating, bending, or abdominal pressure) ≥2 days per week for ≥3 consecutive weeks prior to pre-observation screening
  • ✓Los Angeles Classification grade M (minimal change/discoloring type) on esophagoscopy
  • ✓Continued heartburn ≥2 days per week during final 7 days of observation period
  • ✓≥80% complete heartburn diary entries during observation period (or ≥80% if observation >8 days)
Key exclusion· 18
  • ✕Unable to maintain heartburn diary independently
  • ✕Significant complaints of "feeling of heavy stomach" and/or "abdominal bloating"
  • ✕History or active psychiatric/psychosomatic disease (manic-depressive psychosis, obsessive-compulsive neurosis, etc.) or current antidepressant/anti-anxiety agent use (except hypnotics)
  • ✕H. pylori eradication therapy within 6 months prior to observation period start

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

Search/NCT00165672
NCT00165672Phase 3Completed
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A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease

Eisai Inc.·interventional·Posted Sep 14, 2005·Updated Oct 5, 2011

In Brief

A Phase 3 clinical trial evaluating RABEPRAZOLE SODIUM for Non-erosive Gastroesophageal Reflux Disease. Completed, enrolled 26 participants across 13 sites.

Detailed Summary

To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartMay 1, 2005
Primary CompletionOct 1, 2005
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 20.8 years ago

Interventions

RABEPRAZOLE SODIUMdrug

rabeprazole sodium 5 mg: once daily orally for 4 weeks

RABEPRAZOLE SODIUMdrug

rabeprazole sodium 10 mg: once daily orally for 4 weeks