A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

Phase 4

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Lansoprazole; Drug: Rebamipide-placebo; Drug: Rebamipide

• Registration Number: NCT02755753
• Lead Sponsor: YongChan Lee

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)

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-09-02
• Primary Completion: 2016-01
• Status Verified: 2016-04
• Study Completion: 2016-04
• Study First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Rebamipide-placebo	1. Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast 2. Mucosta®-placebo (rebamipide-placebo), 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Study Group	Lansoprazole	1. Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast 2. Mucosta® (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Control Group	Lansoprazole	1. Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast 2. Mucosta®-placebo (rebamipide-placebo), 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Study Group	Rebamipide	1. Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast 2. Mucosta® (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner

Primary Outcome Measures

Name	Time	Method
Endoscopic healing rate	4 weeks	The ratio of the endoscopically completely healed (normal or minimal change) patients per groups

Secondary Outcome Measures

Name	Time	Method
Time to complete symptom relief	every 2 week, up to 4 week	Interval between inital medication and the first time of symptom relief judged by subject's diary
Histologic change	4 weeks	Histologic change defined with Hematoxylin and eosin (H\&E) stain
Change in inflammatory cytokines	4 weeks	Change in the tissue level of Platelet activating factor (PAF) and Interleukin-8 (IL-8)
Overall symptom relief	every 2 week, up to 4 week	The proportion of relieved subjects at the end of treatment
Adverse events profile	every 2 week, up to 4week	patient's symptoms, physical findings, abnormal laboratory values, vital signs, and ECG findings

Trial Locations

Locations (5)

Soonchunhyang University Bucheon Hospital; 🇰🇷 Bucheon, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Yang Shiming; 🇨🇳 Chongqing, Chongqing, China

Kyungpook National University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Konyang University Hospital; 🇰🇷 Daejeon, Korea, Republic of