Your session is about to expire
← Back to Search
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
Study Summary
This study is evaluating whether a new drug can heal esophageal ulcers in people with GERD.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients With Esophageal Mucosa Healing
Secondary outcome measures
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 moreSide effects data
From 2020 Phase 3 trial • 234 Patients • NCT0305030725%
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
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
303 Previous Clinical Trials
100,578 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger