Erosive EsophagitisPhase 2NCT05055128
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 testing X842, X842 Dummy and Lansoprazole in people with Erosive Esophagitis, run by Cinclus Pharma Holding AB at 42 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- X842, X842 Dummy and Lansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 42 sitesin 8 countries
- Study dates
- 11 Aug 2021to 1 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥ 18 and ≤ 40 kg/m^2 at screening.
- Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:
- LA grade C or D ≤7 days before randomization (with or without historical PPI treatment) or
- LA grade A or B ≤7 days before randomization and history of treatment with the standard healing course of PPI for minimum of 8 weeks prior to screening and ≤7 days of non-treatment during this period and at least partial symptom response during the minimum of 8 weeks of PPI treatment.
- Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).
- Capable of signing informed consent form.
Who cannot join
- History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.
- Patients with so-called "alarm features" in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract.
- Present clinically significant psychiatric diagnosis.
- History of malignancy of any organ system.
- Presence of esophageal ulcer, stricture, Barrett´s esophagus or suspected esophagitis secondary to infection, inflammatory disease, ingestion of erosive chemicals or history of any surgical or medical condition which might significantly alter the Gastro-oesophageal reflux disease (GERD) status or the absorption, distribution, metabolism or excretion of drugs.
- Known severe atrophic gastritis.
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- Any planned major surgery within the duration of the study.
- History of a positive result for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), antibody to Hepatitis B core antigen (anti-HBcAg), or antibody to Hepatitis C virus (anti-HCV) or presence of these findings on screening.
- History of long QTc syndrome (e.g. QTc ≥450 ms for males and ≥470 ms for females).
- Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of screening, as judged by the Investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
- Current or history of alcohol, drug abuse and/or use of anabolic steroids within 2 years prior to screening.
- Women who are pregnant or breastfeeding.
- Patients who have previously participated (completed or withdrawn) in this study CX842A2201.
Trial locations and contacts
42 sites in 8 countries.
42 sites in 8 countries
Bulgaria17 sites
Medical Centre Asklepii
Dupnitsa, Dupnitsa, 2600
Medical Center Medconsult Pleven
Pleven, Pleven, 5800
DCC-1 Sliven
Plovdiv, Plovdiv, 4002
MHAT "Kaspela"
Plovdiv, Plovdiv, 4002
Medical Center Prolet EOOD
Rousse, Ruse, 7000
Diagnostive Consultative Center-1 Sliven
Sliven, Sliven, 8800
Medical Center Hera - Gastroenterology office
Sliven, Sliven, 8800
2-nd MHAT
Sofia, Sofia, 1202
Medical Center Excelsior
Sofia, Sofia, 1407
MHAT "Sveti Ivan Rilski" - Sofia
Sofia, Sofia, 1431
Medical Center Hera - Gastroenterology office
Sofia, Sofia, 1510
Medical Center Excelsior
Sofia, Sofia-Grad, 1233
DCC XIV Sofia
Sofia, Sofia-Grad, 1404
DCC XIV Sofia
Sofia, Sofia-Grad, 1408
Medical Center New Rehabilitation Center EOOD
Stara Zagora, Stara Zagora, 6003
Medical Center "Biomed 99" Ltd
Vidin, 3700
Mhat "Hristo Botev"
Vratsa, Vratsa, 3000
Poland9 sites
NZOZ "Centrum Medyczne KERMED"
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
Lodz, Lódzkie, 90-302
Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
Oświęcim, 32-600
ETG Skierniewice
Skierniewice, 96-100
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-270
Centrum Medyczne Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449
EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, 50-449
EuroMediCare Szpital Specjalistyczny z Przychodnia
Wroclaw, 54-144
ETG Zamosc
Zamość, 22-400
Georgia5 sites
LTD"Brothers"
Batumi, Adjara, 6010
A. Aladashvili clinic LLC
Tbilisi, K'alak'i T'bilisi, 0102
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
Tbilisi, K'alak'i T'bilisi, 0112
LTD TSMU and Ingorokva High Medical Technology University Clinic
Tbilisi, K'alak'i T'bilisi, 0141
Emergency Cardiology Center named by acad. G. Chapidze
Tbilisi, K'alak'i T'bilisi
Hungary4 sites
Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz
Békéscsaba, Bekes County, 5600
Pannonia Maganorvosi Centrum Kft
Budapest, Budapest, H-1136
ClinExpert Kft.
Budapest, Pest County, 1032
Szegedi Tudomanyegyetem Általános Orvostudományi Kar
Szeged, Csongrád megye, H-6725
Ukraine4 sites
Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"
Chernivtsi, Chernivtsi Oblast, 58001
KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"
Odesa, Odesa Oblast, 65025
Medychnyi Tsentr TOV "KHELS KLINIK" - viddil Gasrtroenterology, Hepatology and Endocrinology
Vinnytsia, Vinnytsia Oblast, 21009
KU "6-A miska klinichna likarnia"
Zaporizhzhya, Zaporizhzhia Oblast, 69035
United States1 site
Genesis Clinical Research - Tampa
Tampa, Florida, 33614
About this study
Official title: A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), 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 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.
Read the detailed description
This is a randomized, double-blind, active comparator-controlled study with a parallel-group design including four arms with X842 and one arm with Lansoprazole.
Randomization to one of the treatments with X842 twice daily (BID) 25 mg, 50 mg, 75 mg, 100 mg, or Lansoprazole 30 mg once daily (QD) will be based on a 1:1:1:1:1 scheme.
The duration of each patient's participation in the study, including screening, blind treatment period, and open-label treatment period will be approximately 60 days. The patients will be randomized for 4 weeks of double-blind treatment and will be provided with investigational medicinal product for 35 days.
All patients will have an endoscopic evaluation after 4 weeks of treatment. Following the endoscopic evaluation, all patients will receive subsequent 4 weeks of open-label treatment with Lansoprazole. Repeated symptom evaluation to detect symptom patterns will be assessed during this period.
- Conditions
- Erosive Esophagitis
- Being tested
- X842, X842 Dummy, Lansoprazole, Lansoprazole Dummy
- Keywords
- Lansoprazole, Los Angeles Grade, Double-blind, Active comparator-controlled, Proton-pump inhibitor, Dose selection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X842Drug
Patients will receive X842 tablets.
X842 DummyDrug
Patients will receive matching placebo tablets for X842.
LansoprazoleDrug
Patients will receive Lansoprazole capsule.
Lansoprazole DummyDrug
Patients will receive matching placebo capsules for Lansoprazole.
| Study group | Role | What they receive |
|---|---|---|
| X842 25 mg BID | Experimental | 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. Receives: Drug: X842; Drug: X842 Dummy; Drug: Lansoprazole; Drug: Lansoprazole Dummy |
| X842 50 mg BID | Experimental | 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. Receives: Drug: X842; Drug: X842 Dummy; Drug: Lansoprazole; Drug: Lansoprazole Dummy |
| X842 75 mg BID | Experimental | 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. Receives: Drug: X842; Drug: Lansoprazole; Drug: Lansoprazole Dummy |
| X842 100 mg BID | Experimental | 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. Receives: Drug: X842; Drug: Lansoprazole; Drug: Lansoprazole Dummy |
| Lansoprazole | Active comparator | 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. Receives: Drug: X842 Dummy; Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Esophageal Mucosa Healing
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. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).
Measured: Week 4
Secondary outcomes (5)
Number of Patients With Adverse Events (AEs)
The safety and tolerability of the four dose levels of X842 and Lansoprazole were evaluated, where Lansoprazole served as the active comparator. Here TEAE- Treatment-emergent adverse event, ADR- Adverse drug reaction, SAE- Serious adverse event, and AESI- Adverse events of special interest.
Measured: From Screening (Day -7 to Day 0) until Week 8
Percentage of Heartburn-Free 24-hour Days
Heartburn-free in a 24-hour day was a day where patient reported having no burning feeling or pain behind breast or in center of upper stomach for both morning and evening. Percentage of heartburn-free 24-hour days based on eDiary(Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary) was evaluated. Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with four dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks Lansoprazole treatment in open-label. Modified RESQ-eDiary was validated self-reported questionnaire electronic symptom diary. mRESQ-eD has 3 domains [i.e. Heartburn (min-max: 0-10), Other GERD signs/symptoms (min-max:0-15) and Regurgitations/Reflux (min-max: 0-8)]. Endoscopy followed by lansoprazole administration and symptom evaluation using PRO QOLRAD (Heartburn version) and patient diaries assessed acid control achieved with X842 at 4 weeks.
Measured: Weeks 1 and 8
Percentage at Most-mild Heartburn 24-hour Days
Heartburn with at most mild symptoms in a 24-hour day was defined as a day where the patient reported having either no symptoms, very mild symptoms, or mild burning feeling or pain behind the breast or in the center of the upper stomach (score between 0-2) for both morning and evening. Heartburn assessed the severity as per the following scores (0=Did not have, 1=Very mild, 2=Mild, 3=Moderate, 4=Moderately severe, 5=Severe). Here higher scores represent the worst outcome, whereas lower scores represent the better outcome. After endoscopic evaluation, patients received lansoprazole, and symptom evaluation was conducted to detect patterns. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation involved the use of validated PRO QOLRAD (Heartburn version) and patient diaries.
Measured: Weeks 1 and 8
Investigator Assessment of Symptoms by Frequency and Severity
Investigator assessed severity and frequency of patients' heartburn, regurgitation, and dysphagia in 7 days. Assessment included both severity grade (for severity, items were coded: none, mild, moderate, severe where none represented no complaints, severe represented incapacitating symptoms) and frequency (for frequency, a 7-graded Likert scale was used, ranging from none to all of time) of symptoms. Symptoms were scored as follows: none (no complaints), mild (aware of symptom, but easily tolerated), moderate (discomforting symptom, sufficient to cause interference with normal daily activities and/or sleep), severe (incapacitating symptom, with inability to perform normal daily activities and/or sleep). Following endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD (Heartburn version) and patient diaries.Here, for frequency- All of the time and None of the time, and for symptoms- none and severe data has been presented.
Measured: Weeks 1 and 8
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with 4 dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks of open-label treatment with Lansoprazole. Heartburn version of QOLRAD is a disease-specific instrument containing 25 questions addressing concerns associated with gastrointestinal symptoms. Questions were rated on a seven-grade (1-7) Likert scale, where a score of 1 represented low quality of life, and as score increased, the patient's condition was considered better. Questions were categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning. The score in each domain was calculated as the mean of all items in that domain. The score ranges from 1 to 175, higher scores mean a better outcome. After endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD and patient diaries.
Measured: Baseline, Weeks 1, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start11 Aug 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinclus Pharma Holding AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055128
- Sponsor's protocol ID
- CX842A2201
- Other IDs
- 2020-003319-91
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2021
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Paper Alert. Eur J Gastroenterol Hepatol. 2025 Jul 1;37(7):887-890. doi: 10.1097/MEG.0000000000003011. Epub 2025 May 28.
PubMed 40470733Sharma P, Vaezi M, Unge P, Andersson K, Larsson K, Popadiyn I, Rosenholm M, Rosztoczy A, Yektaei E, Armstrong D. Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis. Aliment Pharmacol Ther. 2025 May;61(10):1590-1602. doi: 10.1111/apt.70109. Epub 2025 Apr 4.
PubMed 40183130
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), 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
- ClinicalTrials.gov ID
- NCT05055128
- Acronym / sponsor ID
- CX842A2201
- Conditions
- Erosive Esophagitis
- Keywords
- Lansoprazole, Los Angeles Grade, Double-blind, Active comparator-controlled, Proton-pump inhibitor, Dose selection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Cinclus Pharma Holding ABIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 1 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, active comparator-controlled study with a parallel-group design including four arms with X842 and one arm with Lansoprazole.
Randomization to one of the treatments with X842 twice daily (BID) 25 mg, 50 mg, 75 mg, 100 mg, or Lansoprazole 30 mg once daily (QD) will be based on a 1:1:1:1:1 scheme.
The duration of each patient's participation in the study, including screening, blind treatment period, and open-label treatment period will be approximately 60 days. The patients will be randomized for 4 weeks of double-blind treatment and will be provided with investigational medicinal product for 35 days.
All patients will have an endoscopic evaluation after 4 weeks of treatment. Following the endoscopic evaluation, all patients will receive subsequent 4 weeks of open-label treatment with Lansoprazole. Repeated symptom evaluation to detect symptom patterns will be assessed during this period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| X842 25 mg BID | Experimental | Drug: X842, Drug: X842 Dummy, Drug: Lansoprazole, Drug: Lansoprazole DummyPatients 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. |
| X842 50 mg BID | Experimental | Drug: X842, Drug: X842 Dummy, Drug: Lansoprazole, Drug: Lansoprazole DummyPatients 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. |
| X842 75 mg BID | Experimental | Drug: X842, Drug: Lansoprazole, Drug: Lansoprazole DummyPatients 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. |
| X842 100 mg BID | Experimental | Drug: X842, Drug: Lansoprazole, Drug: Lansoprazole DummyPatients 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. |
| Lansoprazole | Active comparator | Drug: X842 Dummy, Drug: LansoprazolePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index (BMI) ≥ 18 and ≤ 40 kg/m^2 at screening.
- Gastro-esophageal reflux disease with endoscopically confirmed esophagitis:
- Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).
- Capable of signing informed consent form.
Key exclusion criteria (14 listed)
- History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.
- Patients with so-called "alarm features" in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract.
- Present clinically significant psychiatric diagnosis.
- History of malignancy of any organ system.
- Presence of esophageal ulcer, stricture, Barrett´s esophagus or suspected esophagitis secondary to infection, inflammatory disease, ingestion of erosive chemicals or history of any surgical or medical condition which might significantly alter the Gastro-oesophageal reflux disease (GERD) status or the absorption, distribution, metabolism or excretion of drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X842Patients will receive X842 tablets. | Drug | X842 100 mg BID, X842 25 mg BID, X842 50 mg BID, X842 75 mg BID |
| X842 DummyPatients will receive matching placebo tablets for X842. | Drug | Lansoprazole, X842 25 mg BID, X842 50 mg BID |
| LansoprazolePatients will receive Lansoprazole capsule. | Drug | Lansoprazole, X842 100 mg BID, X842 25 mg BID, X842 50 mg BID, X842 75 mg BID |
| Lansoprazole DummyPatients will receive matching placebo capsules for Lansoprazole. | Drug | X842 100 mg BID, X842 25 mg BID, X842 50 mg BID, X842 75 mg BID |
Primary outcome
Number of Patients With Esophageal Mucosa Healing
Time frame: Week 4
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. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary).
5 secondary outcomes
Number of Patients With Adverse Events (AEs)
Time frame: From Screening (Day -7 to Day 0) until Week 8
Percentage of Heartburn-Free 24-hour Days
Time frame: Weeks 1 and 8
Percentage at Most-mild Heartburn 24-hour Days
Time frame: Weeks 1 and 8
Investigator Assessment of Symptoms by Frequency and Severity
Time frame: Weeks 1 and 8
Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
Time frame: Baseline, Weeks 1, and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40470733Paper Alert. Eur J Gastroenterol Hepatol. 2025 Jul 1;37(7):887-890. doi: 10.1097/MEG.0000000000003011. Epub 2025 May 28.
- Derived from this study: PubMed 40183130Sharma P, Vaezi M, Unge P, Andersson K, Larsson K, Popadiyn I, Rosenholm M, Rosztoczy A, Yektaei E, Armstrong D. Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis. Aliment Pharmacol Ther. 2025 May;61(10):1590-1602. doi: 10.1111/apt.70109. Epub 2025 Apr 4.
- Individual participant dataSharing planned: Undecided
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Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
Gastroesophageal Reflux Disease, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing X842, X842 Dummy and Lansoprazole in people with Erosive Esophagitis, run by Cinclus Pharma Holding AB at 42 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Bulgaria, Poland, Georgia, Hungary, Ukraine and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Esophageal Mucosa Healing (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055128, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.