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

NCT02463643 | Completed Phase 2

• 1 other identifier: Z215-01
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophagitis, Reflux

Outcome Measures

Primary Outcomes (1)

• Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis

  8 weeks

Secondary Outcomes (1)

• Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis

  4 weeks

Study Arms (4)

Z-215 10 mg/day

EXPERIMENTAL

Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo

Drug: Z-215 10mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo

Z-215 20 mg/day

EXPERIMENTAL

Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo

Drug: Z-215 20mg; Drug: Z-215 Placebo; Drug: Rabeprazole Sodium Placebo

Z-215 40 mg/day

EXPERIMENTAL

Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo

Drug: Z-215 20mg; Drug: Rabeprazole Sodium Placebo

Rabeprazole Sodium 10 mg/day

ACTIVE COMPARATOR

Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium

Drug: Z-215 Placebo; Drug: Rabeprazole Sodium

Interventions

Z-215 10mg DRUG

Z-215 10mg, capsules

Z-215 10 mg/day

Z-215 20mg DRUG

Z-215 20mg, capsules

Z-215 20 mg/day; Z-215 40 mg/day

Z-215 Placebo DRUG

Z-215 placebo-matching capsules

Rabeprazole Sodium 10 mg/day; Z-215 10 mg/day; Z-215 20 mg/day

Rabeprazole Sodium DRUG

Rabeprazole Sodium 10mg tablets

Rabeprazole Sodium 10 mg/day

Rabeprazole Sodium Placebo DRUG

Rabeprazole Sodium Placebo placebo-matching tablets

Z-215 10 mg/day; Z-215 20 mg/day; Z-215 40 mg/day

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

JP (1)