Rebamipide

Generic Name: Rebamipide

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₅ClN_₂O_₄

CAS Number: 90098-04-7

Unique Ingredient Identifier: LR583V32ZR

Background: Rebamipide has been investigated for the treatment of Stomach Ulcer, Keratoconjunctivitis Sicca, and Gastric Adenoma and Early Gastric Cancer.

Indication: 主要用于胃溃疡，但不宜单独用于Hp感染。也用于改善胃炎及慢性胃炎急性加重期的胃黏膜病变（如糜烂、出血、充血、水肿等）。

Associated Conditions: Gastric Ulcer

Clinical Trials

Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye

Phase 2

Completed

Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca

Interventions: Drug: rebamipide 2% ophthalmic suspension
Drug: placebo eye drops

First Posted Date: 2009-12-07

Last Posted Date: 2012-01-11

Lead Sponsor: Kubota Vision Inc.

Target Recruit Count: 220

Registration Number: NCT01027013

Locations: 🇺🇸
The Eye Care Group, P.C., Waterbury, Connecticut, United States
🇺🇸
Total Eye Care, P.A., Memphis, Tennessee, United States
🇺🇸
Ora, Inc, Andover, Massachusetts, United States

and more 2 locations

Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Phase 3

Completed

Conditions: Dyspepsia
Chronic Gastritis

Interventions: Drug: Rebamipide

First Posted Date: 2009-10-16

Last Posted Date: 2013-05-15

Lead Sponsor: PT Otsuka Indonesia

Target Recruit Count: 55

Registration Number: NCT00996788

Locations: 🇮🇩
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia, Jakarta, Indonesia

Confirmatory Study of OPC-12759 Ophthalmic Suspension

Phase 3

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: Hyalein Mini Ophthalmic solution
Drug: OPC-12759 Ophthalmic suspension

First Posted Date: 2009-04-21

Last Posted Date: 2013-12-12

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 188

Registration Number: NCT00885079

Locations: 🇯🇵
Kanto region, Tokyo, Japan
🇯🇵
Kansai region, Osaka, Japan
🇯🇵
Kyushu region, Kagoshima, Japan

and more 2 locations

The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries

Not Applicable

Conditions: NSAIDs-induced Small-intestinal Injuries

Interventions: Drug: Rebamipide

First Posted Date: 2009-03-17

Last Posted Date: 2009-09-21

Lead Sponsor: Nagoya University

Target Recruit Count: 60

Registration Number: NCT00862628

Locations: 🇯🇵
Department of Gastroenterology, Nagoya University Graduate School of Medicine, Nagoya, Aichi Prefecture, Japan

Long Term Administration Study of OPC-12759 Ophthalmic Suspension

Phase 3

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: OPC-12759 Ophthalmic suspension

First Posted Date: 2009-01-07

Last Posted Date: 2014-02-26

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 154

Registration Number: NCT00818324

Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy

Phase 4

Completed

Conditions: NSAID Induced Gastropathy

Interventions: Drug: Rebamipide and Esomeprazole

First Posted Date: 2008-03-21

Last Posted Date: 2011-08-24

Lead Sponsor: Otsuka Pharmaceutical, Inc., Philippines

Target Recruit Count: 30

Registration Number: NCT00641004

Locations: 🇵🇭
University of Santo Tomas Hospital, Manila, Philippines
🇵🇭
Armed Forces of the Philippines Medical Center, Quezon City, Philippines
🇵🇭
Candinal Santos medical Center, San Juan City, Philippines

and more 1 locations

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Phase 3

Completed

Conditions: Rheumatoid Arthritis
Osteoarthritis
Ankylosing Spondylitis

Interventions: Drug: Rebamipide
Drug: Misoprostol

First Posted Date: 2007-12-19

Last Posted Date: 2011-11-16

Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 396

Registration Number: NCT00576706

An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis

Phase 2

Completed

Conditions: Colitis, Ulcerative

Interventions: Drug: rebamipide

First Posted Date: 2007-04-20

Last Posted Date: 2021-07-20

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 124

Registration Number: NCT00463151

Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy

Phase 4

Completed

Conditions: Stomach Ulcer

Interventions: Drug: Omeprazole
Drug: Rebamipide

First Posted Date: 2006-01-06

Last Posted Date: 2015-04-29

Lead Sponsor: Korea Otsuka International Asia Arab

Target Recruit Count: 132

Registration Number: NCT00272467

Locations: 🇰🇷
Korea University Ansan Hospital, Ansan, Korea, Republic of
🇰🇷
Severance Hospital, Seoul National University, Seoul, Korea, Republic of
🇨🇳
The 1st Affiliated hospital - Zhongshan Univ., Guangzhou, Guangdong, China

and more 4 locations

Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome

Phase 2

Completed

Conditions: Xerostomia
Sjogren's Syndrome

First Posted Date: 2005-10-05

Last Posted Date: 2021-06-04

Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Target Recruit Count: 104

Registration Number: NCT00233363

Locations: 🇯🇵
Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

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