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A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

NCT05055128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2023-11-01

Study results available
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Summary

This study will be conducted in patients with erosive esophagitis due to gastro-esophageal reflux disease (GERD) Los Angeles (LA) grades C or D, and in patients with at least partial symptom response but still endoscopically unhealed (LA grades A or B) after 8 weeks history of standard treatment healing course with PPI, designed to support dose selection for Phase 3 and to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or Lansoprazole, and symptom pattern during subsequent 4 weeks treatment with Lansoprazole.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

X842

Patients will receive X842 tablets.

DRUG

X842 Dummy

Patients will receive matching placebo tablets for X842.

DRUG

Lansoprazole

Patients will receive Lansoprazole capsule.

DRUG

Lansoprazole Dummy

Patients will receive matching placebo capsules for Lansoprazole.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Cinclus Pharma AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2022-09-01
Completion
2022-09-01
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Georgia
  • Hungary
  • Poland
  • Serbia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05055128 on ClinicalTrials.gov