Clinical trial NCT02755753: A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis
Official title: A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: Rebamipide
Lead sponsor: Severance Hospital
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2016-04-29
Enrollment: 143
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).

Detailed description: 1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients
2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)

Eligibility criteria: Inclusion Criteria:

1. Male/female patients aged 20 to 70 at the time of writing an informed consent.
2. Subjects who were diagnosed with Erosive Reflux Esophagitis (ERE) using Los Angeles (LA) classification grade A\~D, confirmed by endoscopy.
3. The subjects regardless of presence of ERE symptom (i.e., symptomatic ERE or asymptomatic ERE).

   For symptomatic ERE, the subject must have one or more symptoms of the followings: acid regurgitation, heartburn, epigastric pain, cough, hoarseness, globus pharyngis, atypical chest pain.
4. Subjects who have consented to participate in this clinical study by signing an informed consent form.

Exclusion Criteria:

1. Patients with known hypersensitivity to any component of Lanston® and/or Mucosta® formulations.
2. Other concurrent organic upper gastroesophageal disease in endoscopy (i.e., drug-induced esophagitis, viral esophagitis, Mallory-Weiss syndrome, peptic ulcer disease, malignancies) and patients who was diagnosed with Barrett's esophagus.
3. History of abdominal surgery that can affect gastrointestinal motility (except appendectomy and hysterectomy).
4. History of upper gastrointestinal bleeding or obstruction.
5. Patients administrated with any drugs that can affect the efficacy of study regimen (proton pump inhibitors, revaprazan, prokinetics, H2-blockers, etc.) within 2 weeks (however, 4 weeks for PPIs) prior to enrollment and/or those who are required of NSAIDs, anti-coagulants, anti-cholinergics, prostaglandin E, corticosteroids, and anti-depressants treatment during the study period.
6. History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease.
7. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and true abstinence.
8. History of psychological disorder, alcoholics, and drug abuser.
9. Blood test results of hemoglobin (Hb) ≤ 10.0 g/dL, platelets ≤ 50,000 /µL, total WBCs ≤ 4,000/µL or ≥ 10,000/µL, and with serum test results showing the levels of AST, ALT, ALP, BUN, and creatinine exceeding twice the normal range of respective institution.
10. Patients who previously underwent another clinical survey within 4 weeks.
11. History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.

Primary outcomes:
measure: Endoscopic healing rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Histologic change
timeFrame: 4 weeks
measure: Change in inflammatory cytokines
timeFrame: 4 weeks
measure: Time to complete symptom relief
timeFrame: every 2 week, up to 4 week
measure: Overall symptom relief
timeFrame: every 2 week, up to 4 week
measure: Adverse events profile
timeFrame: every 2 week, up to 4week
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Yang Shiming
state: Chongqing
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital, Yonsei University Health System
name: Yong Chan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Medical Center
name: Seong Woo Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Buchen Hospital
name: Su Jin Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Konyang University Hospital
name: Kyung Ho Song, MD, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinqiao Hospital of Chongqing
name: Shiming Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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