Trial · NCT05055128
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, Phase 2, Completed, Cinclus Pharma Holding AB; results first posted 2023-11-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. 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. Trials, record NCT05055128. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05055128
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT05055128
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 248 participants, actual
- Lead sponsor
- Cinclus Pharma Holding AB
- Conditions
- Erosive Esophagitis
- Interventions
- X842, X842 Dummy, Lansoprazole, Lansoprazole Dummy
- First posted
- 2021-09-24
- Last updated
- 2026-07-01
- Other registries' IDs
- eudract:2020-003319-91
- Results first posted
- 2023-11-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Esophageal Mucosa Healing | 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). |
| Secondary | Number of Patients With Adverse Events (AEs) | From Screening (Day -7 to Day 0) until Week 8 | 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. |
| Secondary | Percentage of Heartburn-Free 24-hour Days | Weeks 1 and 8 | 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. |
| Secondary | Percentage at Most-mild Heartburn 24-hour Days | Weeks 1 and 8 | 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. |
| Secondary | Investigator Assessment of Symptoms by Frequency and Severity | Weeks 1 and 8 | 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. |
| Secondary | Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score | Baseline, Weeks 1, and 8 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Esophageal Mucosa Healing | Week 4 | The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug. FAS erosive is a subset of FAS consisted of patients who had been classified as erosive (Grade A, B, C or D) as screening according to the central reading or imputed by local reading if missing. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Adverse Events (AEs) | From Screening (Day -7 to Day 0) until Week 8 | The safety analysis set consisted of all patients who had been randomized and received at least 1 dose of study drug. Patients were analyzed according to the treatment actually received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Heartburn-Free 24-hour Days | Weeks 1 and 8 | The FAS consisted of all patients who had been randomized and received at least 1 dose of the study drug. Here, the Number Analyzed in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week. | Percentage of days | MEAN |
| SECONDARY | Percentage at Most-mild Heartburn 24-hour Days | Weeks 1 and 8 | The FAS consisted of all patients who had been randomized and received at least 1 dose of the study drug. Here, the Number Analyzed in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week. | Percentage of days | MEAN |
| SECONDARY | Investigator Assessment of Symptoms by Frequency and Severity | Weeks 1 and 8 | The FAS consisted of all patients who had been randomized and received at least 1 dose of the study drug. Here, the Number Analyzed in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score | Baseline, Weeks 1, and 8 | The FAS consisted of all patients who had been randomized and received at least 1 dose of study drug. Here, the Number Analyzed in the table represents the count of patients who were measured and analyzed for the specific Outcome Measure during the given week. | Scores on scale | MEAN |
Source ClinicalTrials.gov
Results by group235
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Esophageal Mucosa Healing | X842 25 mg BID | 28 | Participants | ||
| Number of Patients With Esophageal Mucosa Healing | X842 50 mg BID | 28 | Participants | ||
| Number of Patients With Esophageal Mucosa Healing | X842 75 mg BID | 32 | Participants | ||
| Number of Patients With Esophageal Mucosa Healing | X842 100 mg BID | 18 | Participants | ||
| Number of Patients With Esophageal Mucosa Healing | Lansoprazole | 20 | Participants | ||
| Number of Patients With Adverse Events (AEs) | X842 25 mg BID | Any AE | 15 | Participants | |
| Number of Patients With Adverse Events (AEs) | X842 50 mg BID | Any AE | 10 | Participants | |
| Number of Patients With Adverse Events (AEs) | X842 75 mg BID | Any AE | 12 | Participants | |
| Number of Patients With Adverse Events (AEs) | X842 100 mg BID | Any AE | 11 | Participants | |
| Number of Patients With Adverse Events (AEs) | Lansoprazole | Any AE | 10 | Participants |
1 to 10 of 235Source ClinicalTrials.gov
See all 235 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | X842 25 mg BID | 51 | |
| Overall Study | STARTED | X842 50 mg BID | 48 | |
| Overall Study | STARTED | X842 75 mg BID | 52 | |
| Overall Study | STARTED | X842 100 mg BID | 47 | |
| Overall Study | STARTED | Lansoprazole | 50 | |
| Overall Study | COMPLETED | X842 25 mg BID | 45 | |
| Overall Study | COMPLETED | X842 50 mg BID | 45 | |
| Overall Study | COMPLETED | X842 75 mg BID | 50 | |
| Overall Study | COMPLETED | X842 100 mg BID | 41 | |
| Overall Study | COMPLETED | Lansoprazole | 47 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events260
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | X842 25 mg BID | 1 | 51 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | X842 50 mg BID | 0 | 48 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | X842 75 mg BID | 1 | 52 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | X842 100 mg BID | 0 | 47 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Lansoprazole | 0 | 50 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | X842 25 mg BID | 0 | 51 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | X842 50 mg BID | 0 | 48 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | X842 75 mg BID | 0 | 52 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | X842 100 mg BID | 0 | 47 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Lansoprazole | 1 | 50 | 1 |
1 to 10 of 260Source ClinicalTrials.gov
See all 260 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | X842 25 mg BID | 0 | 51 |
| Total, all-cause mortality | X842 50 mg BID | 0 | 48 |
| Total, all-cause mortality | X842 75 mg BID | 0 | 52 |
| Total, all-cause mortality | X842 100 mg BID | 0 | 47 |
| Total, all-cause mortality | Lansoprazole | 0 | 50 |
| Total, other adverse events | X842 25 mg BID | 14 | 51 |
| Total, other adverse events | X842 50 mg BID | 10 | 48 |
| Total, other adverse events | X842 75 mg BID | 12 | 52 |
| Total, other adverse events | X842 100 mg BID | 11 | 47 |
| Total, other adverse events | Lansoprazole | 10 | 50 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05055128
GET https://conductscience.org/api/trials/v1/NCT05055128/results?page=2