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Proton Pump Inhibitor

Lansoprazole for Erosive Esophagitis

Phase 2
Waitlist Available
Research Sponsored by Cinclus Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (day -7 to day 0) until week 8
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug (X842) against an existing one (Lansoprazole) for treating severe acid reflux. It focuses on patients who haven't fully healed after standard treatment. Both drugs work by reducing stomach acid to help heal the esophagus. Lansoprazole has been shown to be effective in treating reflux esophagitis.

Eligible Conditions
  • Erosive Esophagitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -7 to day 0) until week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -7 to day 0) until week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With Esophageal Mucosa Healing
Secondary study objectives
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Investigator Assessment of Symptoms by Frequency and Severity
Number of Patients With Adverse Events (AEs)
+2 more

Side effects data

From 2020 Phase 3 trial • 234 Patients • NCT03050307
25%
Pepsinogen test positive
21%
Blood gastrin increased
20%
Pepsinogen I increased
5%
Alanine aminotransferase increased
2%
Dysgeusia
1%
Gastric cancer
1%
Appendicitis
1%
Meningitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-438 20 mg
Lansoprazole 30 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: X842 75 mg BIDExperimental Treatment3 Interventions
Patients will receive 2 tablets (X842 50 mg + X842 25 mg) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 25 mg) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Group II: X842 50 mg BIDExperimental Treatment4 Interventions
Patients will receive 2 tablets (X842 50 mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Group III: X842 25 mg BIDExperimental Treatment4 Interventions
Patients will receive 2 tablets (X842 25mg + X842 dummy) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 25 mg + X842 dummy) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Group IV: X842 100 mg BIDExperimental Treatment3 Interventions
Patients will receive 2 tablets (X842 50 mg×2) and 1 capsule (Lansoprazole dummy) in the morning, and 2 tablets (X842 50 mg×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Group V: LansoprazoleActive Control2 Interventions
Patients will receive 2 tablets (X842 dummy×2) and 1 capsule (Lansoprazole 30 mg) in the morning, and 2 tablets (X842 dummy×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
X842
2021
Completed Phase 2
~250
Lansoprazole
2017
Completed Phase 4
~15270
Lansoprazole Dummy
2021
Completed Phase 2
~250
X842 Dummy
2021
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Cinclus Pharma AGLead Sponsor
3 Previous Clinical Trials
206 Total Patients Enrolled
ParexelIndustry Sponsor
309 Previous Clinical Trials
100,680 Total Patients Enrolled
~60 spots leftby Oct 2025
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