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OpenTrials
Completed

NCT Number: NCT02463643

To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis

The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.

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Key information

Conditions

Esophagitis, Reflux Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In observation period, the participant must have endoscopically confirmed erosive esophagitis of Grade A to D, as defined by the LA classification grading system, and the target number of participants who are clearly Grade C or D is 20% (96 participants) or more of the total participants.
  • Outpatient (including inpatient for examination)

Exclusion criteria

  • Participants with a previous or current history of eosinophilic esophagitis,scleroderma, esophageal stenosis, esophageal varices, Barrett's esophagus ( columnar epithelium metaplasia>=3 cm ) or high-grade dysplasia.However, participants with Schatzki's ring ( >=20mm ) are allowed to be included.
  • Participants who have acute upper gastrointestinal bleeding, gastric or duodenal ulcer (mucosal defect with white coating>=3mm) within 28 days prior to observation period . Participants with above disease at endoscopy during the observation period.
  • Participants with Zollinger-Ellison syndrome.Participants with suspected gastric acid hypersecretion disorders attributable to hyperparathyroidism and others.
  • Participants with a previous history of surgery of esophagus,stomach or duodenum (excluding removal of benign polyp by endoscopic polypectomy) .

Treatment and study plan

Z-215 10mg

Drug

Z-215 10mg, capsules

Z-215 20mg

Drug

Z-215 20mg, capsules

Z-215 Placebo

Drug

Z-215 placebo-matching capsules

RABEPRAZOLE SODIUM

Drug

Rabeprazole Sodium 10mg tablets

Rabeprazole Sodium Placebo

Drug

Rabeprazole Sodium Placebo placebo-matching tablets

Primary outcomes

  1. Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis

    Time frame: 8 weeks

Secondary outcomes

  1. Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Zeria Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Z-215 Compared With Rabeprazole Sodium in the Treatment of Erosive Esophagitis

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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