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NCT05055128 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Erosive Esophagitis, sponsored by Cinclus Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 248
- Enrollment target
- 20
- Study locations
NCT05055128: Completed Phase 2 study of Erosive Esophagitis, sponsored by Cinclus Pharma.
NCT05055128 is a Phase 2 study of Erosive Esophagitis that has completed, run by Cinclus Pharma. The registered enrollment target is 248 participants, above the 169-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05055128, a Phase 2 study of Erosive Esophagitis, has completed, sponsored by Cinclus Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 248 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repe
Conditions Studied
Interventions
- DRUG Lansoprazole
- DRUG X842
- DRUG X842 Dummy
- DRUG Lansoprazole Dummy
Study Locations (20)
Other
- Medical Centre Asklepii - Dupnitsa
- Medical Center Medconsult Pleven - Pleven
- DCC-1 Sliven - Plovdiv
- MHAT "Kaspela" - Plovdiv
- Medical Center Prolet EOOD - Rousse
- Diagnostive Consultative Center-1 Sliven - Sliven
- Medical Center Hera - Gastroenterology office - Sliven
- 2-nd MHAT - Sofia
- Medical Center Excelsior - Sofia
- MHAT "Sveti Ivan Rilski" - Sofia - Sofia
- Medical Center Hera - Gastroenterology office - Sofia
- Medical Center New Rehabilitation Center EOOD - Stara Zagora
- Medical Center "Biomed 99" Ltd - Vidin
- Mhat "Hristo Botev" - Vratsa
- ResTrial GastroEndo s.r.o. - Prague
Sofia-Grad
- Medical Center Excelsior - Sofia
- DCC XIV Sofia - Sofia
- DCC XIV Sofia - Sofia
Florida
- Genesis Clinical Research - Tampa - Tampa
Adjara
- LTD"Brothers" - Batumi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2021-08-11 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 2 |
What the finished NCT05055128 record still lists
NCT05055128 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, above the 169-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (47% higher).
The record links to 1 condition, with Erosive Esophagitis appearing as the primary indexed condition, and to 4 interventions - of which Lansoprazole is the first listed.
NCT05055128 names 20 study sites across 4 states, led by Other, Sofia-Grad, Florida.
Frequently Asked Questions
What is clinical trial NCT05055128 about?
NCT05055128 is a clinical study titled "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". 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 hea...
What is the current status of trial NCT05055128?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2021-08-11. Estimated completion is 2022-09-01.
What conditions does trial NCT05055128 study?
This clinical trial studies the following conditions: Erosive Esophagitis.
What interventions are being tested in trial NCT05055128?
The interventions under investigation include: Lansoprazole (DRUG), X842 (DRUG), X842 Dummy (DRUG), Lansoprazole Dummy (DRUG).
Who is sponsoring clinical trial NCT05055128?
This trial is sponsored by Cinclus Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05055128 being conducted?
This trial has 20 study locations across Florida, Sofia-Grad, Adjara. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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