Back to resultsA 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
Primary Purpose
Erosive Esophagitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
X842
X842 Dummy
Lansoprazole
Lansoprazole Dummy
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis focused on measuring Lansoprazole, Los Angeles Grade, Double-blind, Active comparator-controlled, Proton-pump inhibitor, Dose selection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Genesis Clinical Research - Tampa
- Medical Center Excelsior
- DCC XIV Sofia
- DCC XIV Sofia
- Medical Centre Asklepii
- Medical Center Medconsult Pleven
- DCC-1 Sliven
- MHAT "Kaspela"
- Medical Center Prolet EOOD
- Diagnostive Consultative Center-1 Sliven
- Medical Center Hera - Gastroenterology office
- 2-nd MHAT
- Medical Center Excelsior
- MHAT "Sveti Ivan Rilski" - Sofia
- Medical Center Hera - Gastroenterology office
- Medical Center New Rehabilitation Center EOOD
- Medical Center "Biomed 99" Ltd
- Mhat "Hristo Botev"
- ResTrial GastroEndo s.r.o.
- LTD"Brothers"
- A. Aladashvili clinic LLC
- LTD Israeli-Georgian Medical Research Clinic "Helsicore"
- LTD TSMU and Ingorokva High Medical Technology University Clinic
- Emergency Cardiology Center named by acad. G. Chapidze
- Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz
- Szegedi Tudomanyegyetem Általános Orvostudományi Kar
- ClinExpert Kft.
- Pannonia Maganorvosi Centrum Kft
- Centrum Medyczne Melita Medical
- NZOZ "Centrum Medyczne KERMED"
- Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
- Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
- ETG Skierniewice
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- EuroMediCare Szpital Specjalistyczny z Przychodnia
- EuroMediCare Szpital Specjalistyczny z Przychodnia
- ETG Zamosc
- Zvezdara University Medical Center
- Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"
- KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"
- Medychnyi Tsentr TOV "KHELS KLINIK" - viddil Gasrtroenterology, Hepatology and Endocrinology
- KU "6-A miska klinichna likarnia"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
X842 25 mg BID
X842 50 mg BID
X842 75 mg BID
X842 100 mg BID
Lansoprazole
Arm Description
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.
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.
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×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
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.
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.
Outcomes
Primary Outcome Measures
Healing rate of erosive esophagitis
To assess the healing rate of erosive esophagitis due to GERD based on endoscopic assessment. Dose selection for X842 (to identify the dose providing the target effect of 85% healing rate) will be supported through assessment of healing of erosive esophagitis after 4 weeks of treatment.
Secondary Outcome Measures
Number of patients with adverse events (AEs)
To assess safety and tolerability of the four dose levels of X842 and Lansoprazole, where Lansoprazole will serve as the active comparator.
Percentage of heartburn-free 24-hour days
To evaluate the percentage to heartburn-free 24-hour days based on eDiary (Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary). The reflux related symptom pattern will be evaluated during the initial 4 weeks treatment with four dose levels of X842 and with Lansoprazole, and the symptom pattern during the subsequent additional 4 weeks (Weeks 5-8) open-label treatment with Lansoprazole. Modified RESQ-eDiary is a 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)]. It is used to assess the severity and frequency of gastroesophageal reflux disease symptoms. For severity a 6-point and for frequency a 5-point Likert response format is used. RESQ-eD contains 8 items where 5 assess severity (0=Did not have - 5=Severe) and 3 assess frequency (0=Never - 4=Very often) of symptoms (min-max: 0-33). Higher scores mean a worse outcome.
Investigator assessment of symptom
Investigator will assess the severity of patients' heartburn, regurgitation and dysphagia in the 7 days prior to the visit. The assessment will include both the severity grade (for severity, items are coded: none, mild, moderate, severe where none represents no complaints, severe represents incapacitating symptoms) and the frequency (for frequency, a 7-graded Likert scale is used, ranges from none of the time to all of the time) of symptoms. Symptoms are 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).
Change from baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) score
The reflux related symptom pattern will be evaluated during the initial 4 weeks treatment with four dose levels of X842 and with Lansoprazole, and the symptom pattern during the subsequent additional 4 weeks (Weeks 5-8) open-label treatment with Lansoprazole 30 mg QD. The heartburn version of the QOLRAD is a disease specific instrument and contains 25 questions addressing concerns associated with gastrointestinal symptoms. The questions are rated on a seven-grade (1-7) Likert scale, score of 1 represents low quality of life and as higher the score the better is the patient. If 50% or more of the questions in one dimension are completed, the mean value of the completed items should replace the missing responses. The questions are categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems and physical/social functioning. The score ranges from 1 to 175, higher scores mean a better outcome.
Full Information
NCT ID
NCT05055128
First Posted
September 14, 2021
Last Updated
September 29, 2022
Sponsor
Cinclus Pharma AG
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT05055128
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cinclus Pharma AG
Collaborators
Parexel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
Keywords
Lansoprazole, Los Angeles Grade, Double-blind, Active comparator-controlled, Proton-pump inhibitor, Dose selection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
X842 25 mg BID
Arm Type
Experimental
Arm Description
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.
Arm Title
X842 50 mg BID
Arm Type
Experimental
Arm Description
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.
Arm Title
X842 75 mg BID
Arm Type
Experimental
Arm Description
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×2) in the evening during 4-week double-blind treatment. Thereafter, patients will receive 1 capsule of Lansoprazole 30 mg QD for 4 weeks.
Arm Title
X842 100 mg BID
Arm Type
Experimental
Arm Description
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.
Arm Title
Lansoprazole
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
X842
Intervention Description
Patients will receive X842 tablets.
Intervention Type
Drug
Intervention Name(s)
X842 Dummy
Intervention Description
Patients will receive matching placebo tablets for X842.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
Patients will receive Lansoprazole capsule.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole Dummy
Intervention Description
Patients will receive matching placebo capsules for Lansoprazole.
Primary Outcome Measure Information:
Title
Healing rate of erosive esophagitis
Description
To assess the healing rate of erosive esophagitis due to GERD based on endoscopic assessment. Dose selection for X842 (to identify the dose providing the target effect of 85% healing rate) will be supported through assessment of healing of erosive esophagitis after 4 weeks of treatment.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of patients with adverse events (AEs)
Description
To assess safety and tolerability of the four dose levels of X842 and Lansoprazole, where Lansoprazole will serve as the active comparator.
Time Frame
From Screening (Day -7 to Day 0) until Week 8
Title
Percentage of heartburn-free 24-hour days
Description
To evaluate the percentage to heartburn-free 24-hour days based on eDiary (Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary). The reflux related symptom pattern will be evaluated during the initial 4 weeks treatment with four dose levels of X842 and with Lansoprazole, and the symptom pattern during the subsequent additional 4 weeks (Weeks 5-8) open-label treatment with Lansoprazole. Modified RESQ-eDiary is a 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)]. It is used to assess the severity and frequency of gastroesophageal reflux disease symptoms. For severity a 6-point and for frequency a 5-point Likert response format is used. RESQ-eD contains 8 items where 5 assess severity (0=Did not have - 5=Severe) and 3 assess frequency (0=Never - 4=Very often) of symptoms (min-max: 0-33). Higher scores mean a worse outcome.
Time Frame
Weeks 1, 2, 4 and 8
Title
Investigator assessment of symptom
Description
Investigator will assess the severity of patients' heartburn, regurgitation and dysphagia in the 7 days prior to the visit. The assessment will include both the severity grade (for severity, items are coded: none, mild, moderate, severe where none represents no complaints, severe represents incapacitating symptoms) and the frequency (for frequency, a 7-graded Likert scale is used, ranges from none of the time to all of the time) of symptoms. Symptoms are 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).
Time Frame
Week 1-8
Title
Change from baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) score
Description
The reflux related symptom pattern will be evaluated during the initial 4 weeks treatment with four dose levels of X842 and with Lansoprazole, and the symptom pattern during the subsequent additional 4 weeks (Weeks 5-8) open-label treatment with Lansoprazole 30 mg QD. The heartburn version of the QOLRAD is a disease specific instrument and contains 25 questions addressing concerns associated with gastrointestinal symptoms. The questions are rated on a seven-grade (1-7) Likert scale, score of 1 represents low quality of life and as higher the score the better is the patient. If 50% or more of the questions in one dimension are completed, the mean value of the completed items should replace the missing responses. The questions are categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems and physical/social functioning. The score ranges from 1 to 175, higher scores mean a better outcome.
Time Frame
Baseline, Weeks 1, 2, 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
Genesis Clinical Research - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Medical Center Excelsior
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
DCC XIV Sofia
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
DCC XIV Sofia
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Medical Centre Asklepii
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Medical Center Medconsult Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
DCC-1 Sliven
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
MHAT "Kaspela"
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Medical Center Prolet EOOD
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Diagnostive Consultative Center-1 Sliven
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Medical Center Hera - Gastroenterology office
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
2-nd MHAT
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Medical Center Excelsior
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
MHAT "Sveti Ivan Rilski" - Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center Hera - Gastroenterology office
City
Sofia
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Medical Center New Rehabilitation Center EOOD
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Medical Center "Biomed 99" Ltd
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
Mhat "Hristo Botev"
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Facility Name
ResTrial GastroEndo s.r.o.
City
Praha 4
ZIP/Postal Code
143 00
Country
Czechia
Facility Name
LTD"Brothers"
City
Batumi
State/Province
Ajaria
ZIP/Postal Code
6010
Country
Georgia
Facility Name
A. Aladashvili clinic LLC
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
LTD Israeli-Georgian Medical Research Clinic "Helsicore"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD TSMU and Ingorokva High Medical Technology University Clinic
City
Tbilisi
ZIP/Postal Code
0141
Country
Georgia
Facility Name
Emergency Cardiology Center named by acad. G. Chapidze
City
Tbilisi
Country
Georgia
Facility Name
Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz
City
Békéscsaba
State/Province
Békés
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Általános Orvostudományi Kar
City
Szeged
State/Province
Csongrád
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
ClinExpert Kft.
City
Budapest
State/Province
Pest
ZIP/Postal Code
1032
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft
City
Budapest
ZIP/Postal Code
H-1136
Country
Hungary
Facility Name
Centrum Medyczne Melita Medical
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-449
Country
Poland
Facility Name
NZOZ "Centrum Medyczne KERMED"
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi
City
Lodz
State/Province
Lódzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
ETG Skierniewice
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Twoja Przychodnia - Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-270
Country
Poland
Facility Name
EuroMediCare Szpital Specjalistyczny z Przychodnia
City
Wrocław
ZIP/Postal Code
50-449
Country
Poland
Facility Name
EuroMediCare Szpital Specjalistyczny z Przychodnia
City
Wrocław
ZIP/Postal Code
54-144
Country
Poland
Facility Name
ETG Zamosc
City
Zamość
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Zvezdara University Medical Center
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"
City
Chernivtsi
State/Province
Chernivets'ka Oblast'
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"
City
Odesa
State/Province
Odes'ka Oblast'
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Medychnyi Tsentr TOV "KHELS KLINIK" - viddil Gasrtroenterology, Hepatology and Endocrinology
City
Vinnytsia
State/Province
Vinnyts'ka Oblast'
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
KU "6-A miska klinichna likarnia"
City
Zaporizhzhia
State/Province
Zaporiz'ka Oblast'
ZIP/Postal Code
69035
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
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