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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 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05055128
The ClinicalTrials.gov registry entry for NCT05055128 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cinclus Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05055128 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Sofia-Grad, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05055128?
The interventions under investigation include: Lansoprazole (DRUG), X842 (DRUG), X842 Dummy (DRUG), Lansoprazole Dummy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05055128?
This trial is sponsored by Cinclus Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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