← Back to Search

Proton Pump Inhibitor

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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (day -7 to day 0) until week 8

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

Alanine aminotransferase increased

Dysgeusia

Gastric cancer

Appendicitis

Meningitis

100%

80%

60%

40%

20%

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