A double-blind study in patients with reflux esophagitis 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

Phase 1

Conditions: erosive esophagitis due to GERD Los Angeles grade C or D and patients with grades A or B who partially responded to PPI patients with grades A or B who partially responded to PPI
MedDRA version: 20.1Level: LLTClassification code 10063657Term: Erosive esophagitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2020-003319-91-BG

Lead Sponsor: Cinclus Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. Written informed consent must be obtained before any study related assessment is performed.
2. Male or female patient aged 18-75 years inclusive at the time of obtaining the informed consent .
3. Body mass index (BMI) = 18 and = 40 kg/m2 at screening
4. 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 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.
Note: partial symptom response is defined as a clear symptom improvement (heartburn or regurgitation) after start of the PPI treatment course. To qualify, the patient's response must be YES to the Investigator´s standardized question to the patient: Did you feel a clear symptom improvement in heartburn or regurgitation after you started the PPI treatment course?
* All PPIs EXCEPT lansoprazole
** Non-treatment days are counted from end day of PPI therapy until
endoscopy demonstrating erosive esophagitis due to GERD.
5. Willing and able to comply with all aspects of the protocol (including PK sampling, capsule swallowing, diary completion, etc.)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

1. Female pts of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using one of the following adequate methods of contraception during dosing and for at least 7 days after the last dose of study medication:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
•Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking the first dose of study treatment. In case of oophorectomy alone, only when the reproductive status of the patient has been confirmed by follow-up hormone level assessment
•Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that pt.
•Placement of a non-hormonal IUD
•Double barrier methods of contraception: condom in combination with occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/vaginal suppository
Note: Patients who are already on hormonal contraceptives prior to study enrollment must agree to:
• replace hormonal contraception with double barrier method or
• use double barrier contraception method in addition to the hormonal contraceptives
2.Female pts of non-childbearing potential not requiring a contraceptive method, are defined as
• Pre-menopausal females with a documented tubal ligation or hysterectomy; or
• Post-menopausal females defined as at least 12 months of amenorrhea (without an alternative medical cause) and confirmed with simultaneous serum follicle stimulation hormone (FSH), consistent with post-menopausal status according to central laboratory ranges.
Patients who do not meet one of these two criteria above will be considered being of childbearing potential, and are excluded unless using one of the adequate contraceptive methods defined in Exclusion Criterion #1.
3.Male pts with a partner of childbearing potential, unless they are willing to use condoms in combination with a second method of adequate contraception (e.g. double barrier method), and they agree not to father a child during dosing and for at least 7 days after the last dose of study medication. Each male pt will be considered as potent unless surgically sterilized (at least 6 months prior to screening).
4.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 GERD status or the absorption, distribution, metabolism or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major gastrointestinal surgery such as gastrectomy, gastroenterostomy, bowel resection or transjugular intrahepatic portosystemic shunt (TIPS)
5.Known severe atrophic gastritis
6.Any planned major surgery within the duration of the study
7.Any clinically significant laboratory parameter outside reference value that, in the opinion of the Investigator, may suggest a new or insufficiently understood disease, may present an unreasonable risk to the patient as a result of his/her participation in the study, or may interfere with study assessments.
Any of these screening laboratory tes

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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