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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003319-91 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X842 | Drug | Patients will receive X842 tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Screening (Day -7 to Day 0) until Week 8 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Clinical Research - Tampa | Tampa | Florida | 33614 | United States | ||
| Medical Centre Asklepii |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40470733 | Derived | Paper Alert. Eur J Gastroenterol Hepatol. 2025 Jul 1;37(7):887-890. doi: 10.1097/MEG.0000000000003011. Epub 2025 May 28. | |
| 40183130 | Derived | Sharma 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. |
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The pre-treatment assessments were performed during the screening period (Day -7 to Day 0) prior to the first dose preferably. All the study assessments were performed as per the schedule of assessments.
This study was conducted at 36 centers which included 248 patients across 08 countries. The trial began on 11 Aug 2021 (first patient enrolled) and was completed on 01 Sep 2022 (Last patient completed).
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| ID | Title | Description |
|---|---|---|
| FG000 | X842 25 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2022 | Aug 24, 2023 |
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|
| 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. |
|
| X842 Dummy | Drug | Patients will receive matching placebo tablets for X842. |
|
| Lansoprazole | Drug | Patients will receive Lansoprazole capsule. |
|
| Lansoprazole Dummy | Drug | Patients will receive matching placebo capsules for Lansoprazole. |
|
| 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. | 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. | 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. | 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. | Baseline, Weeks 1, and 8 |
| Dupnitsa |
| Dupnitsa |
| 2600 |
| Bulgaria |
| Medical Center Medconsult Pleven | Pleven | Pleven | 5800 | Bulgaria |
| DCC-1 Sliven | Plovdiv | Plovdiv | 4002 | Bulgaria |
| MHAT "Kaspela" | Plovdiv | Plovdiv | 4002 | Bulgaria |
| Medical Center Prolet EOOD | Rousse | Ruse | 7000 | Bulgaria |
| Diagnostive Consultative Center-1 Sliven | Sliven | Sliven | 8800 | Bulgaria |
| Medical Center Hera - Gastroenterology office | Sliven | Sliven | 8800 | Bulgaria |
| 2-nd MHAT | Sofia | Sofia | 1202 | Bulgaria |
| Medical Center Excelsior | Sofia | Sofia | 1407 | Bulgaria |
| MHAT "Sveti Ivan Rilski" - Sofia | Sofia | Sofia | 1431 | Bulgaria |
| Medical Center Hera - Gastroenterology office | Sofia | Sofia | 1510 | Bulgaria |
| Medical Center Excelsior | Sofia | Sofia-Grad | 1233 | Bulgaria |
| DCC XIV Sofia | Sofia | Sofia-Grad | 1404 | Bulgaria |
| DCC XIV Sofia | Sofia | Sofia-Grad | 1408 | Bulgaria |
| Medical Center New Rehabilitation Center EOOD | Stara Zagora | Stara Zagora | 6003 | Bulgaria |
| Mhat "Hristo Botev" | Vratsa | Vratsa | 3000 | Bulgaria |
| Medical Center "Biomed 99" Ltd | Vidin | 3700 | Bulgaria |
| ResTrial GastroEndo s.r.o. | Prague | 143 00 | Czechia |
| LTD"Brothers" | Batumi | Adjara | 6010 | Georgia |
| A. Aladashvili clinic LLC | Tbilisi | K'alak'i T'bilisi | 0102 | Georgia |
| LTD Israeli-Georgian Medical Research Clinic "Helsicore" | Tbilisi | K'alak'i T'bilisi | 0112 | Georgia |
| LTD TSMU and Ingorokva High Medical Technology University Clinic | Tbilisi | K'alak'i T'bilisi | 0141 | Georgia |
| Emergency Cardiology Center named by acad. G. Chapidze | Tbilisi | K'alak'i T'bilisi | Georgia |
| Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz | Békéscsaba | Bekes County | 5600 | Hungary |
| Pannonia Maganorvosi Centrum Kft | Budapest | Budapest | H-1136 | Hungary |
| Szegedi Tudomanyegyetem Általános Orvostudományi Kar | Szeged | Csongrád megye | H-6725 | Hungary |
| ClinExpert Kft. | Budapest | Pest County | 1032 | Hungary |
| NZOZ "Centrum Medyczne KERMED" | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-681 | Poland |
| Centrum Medyczne Melita Medical | Wroclaw | Lower Silesian Voivodeship | 50-449 | Poland |
| Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi | Lodz | Lódzkie | 90-302 | Poland |
| Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o. | Oświęcim | 32-600 | Poland |
| ETG Skierniewice | Skierniewice | 96-100 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-270 | Poland |
| EuroMediCare Szpital Specjalistyczny z Przychodnia | Wroclaw | 50-449 | Poland |
| EuroMediCare Szpital Specjalistyczny z Przychodnia | Wroclaw | 54-144 | Poland |
| ETG Zamosc | Zamość | 22-400 | Poland |
| Zvezdara University Medical Center | Belgrade | Belgrade | 11000 | Serbia |
| Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia" | Chernivtsi | Chernivtsi Oblast | 58001 | Ukraine |
| KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady" | Odesa | Odesa Oblast | 65025 | Ukraine |
| Medychnyi Tsentr TOV "KHELS KLINIK" - viddil Gasrtroenterology, Hepatology and Endocrinology | Vinnytsia | Vinnytsia Oblast | 21009 | Ukraine |
| KU "6-A miska klinichna likarnia" | Zaporizhzhia | Zaporizhzhia Oblast | 69035 | Ukraine |
| X842 50 mg BID |
Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| FG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| FG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| FG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS) consisted of all patients who have been randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | X842 25 mg BID | Patients received 2 tablets (X842 25 mg + 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| BG001 | X842 50 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| BG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| BG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| BG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Count of Participants | Participants | Week 4 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | From Screening (Day -7 to Day 0) until Week 8 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Error | Percentage of days | Weeks 1 and 8 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Error | Percentage of days | Weeks 1 and 8 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Weeks 1 and 8 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Error | Scores on scale | Baseline, Weeks 1, and 8 |
|
From Screening (Day -7 to Day 0) until Week 8
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | X842 25 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. | 0 | 51 | 1 | 51 | 14 | 51 |
| EG001 | X842 50 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. | 0 | 48 | 0 | 48 | 10 | 48 |
| EG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. | 0 | 52 | 1 | 52 | 12 | 52 |
| EG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. | 0 | 47 | 0 | 47 | 11 | 47 |
| EG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. | 0 | 50 | 0 | 50 | 10 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | 23.0 | Non-systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 23.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | 23.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 23.0 | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | 24.0 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Gastrointestinal hypermotility | Gastrointestinal disorders | 23.0 | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | 24.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | 24.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Non-systematic Assessment |
| |
| Mucosal dryness | General disorders | 24.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | 24.0 | Non-systematic Assessment |
| |
| Hepatobiliary disorders | General disorders | 23.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | 24.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | 24.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | 24.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | 24.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 24.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.0 | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | 24.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | 24.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.0 | Non-systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | 24.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 24.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | 24.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | Non-systematic Assessment |
|
This document contains confidential information about Cinclus Pharma Holding AB. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you agree to hold such information in confidence and not to disclose it to others (except where required by applicable law), nor use it for unauthorized purposes. In the event of an actual or suspected breach of this obligation, Cinclus Pharma Holding AB should be promptly notified.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kajsa Larsson, MD, PhD | Cinclus Pharma Holding AB | +46 70 675 01 28 | kajsa.larsson@cincluspharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2023 | Aug 24, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
|
|
| OG001 |
| X842 50 mg BID |
Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
|
|
Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
|
|
| OG001 | X842 50 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks |
|
|
| OG001 | X842 50 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG002 | X842 75 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG003 | X842 100 mg BID | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
| OG004 | Lansoprazole | Patients received 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 received 1 capsule of Lansoprazole 30 mg QD for 4 weeks. |
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