Page last updated: 2024-11-03

opc 12759 and Stomatitis

opc 12759 has been researched along with Stomatitis in 15 studies

rebamipide: structure in first source; RN refers to (+-)-isomer; inhibits gastric xanthine oxidase

Stomatitis: INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP.

Research Excerpts

ExcerptRelevanceReference
" We retrospectively examined the progression of oral mucositis in 91 patients with breast cancer who received the 5-fluorouracil, epirubicin, and cyclophosphamide (FEC)-100 regimen between September 2007 and August 2008."3.80[Therapeutic effect of rebamipide for oral mucositis associated with FEC therapy for breast cancer]. ( Abe, M; Bamba, N; Enami, A; Makihara, K; Masaoka, M; Masuda, N; Mizutani, M; Shikata, A; Takada, S; Yamamoto, M; Yamamura, J; Yasojima, H, 2014)
"In the treatment of head and neck cancer, severity of chemoradiotherapy-induced oral mucositis has been recognized as one of the key factors affecting the outcomes of the anticancer therapies."2.90The post hoc analysis comparing the severity grades of chemoradiotherapy-induced oral mucositis scored between the central and local assessors in a multicenter, randomized controlled trial of rebamipide for head and neck cancer. ( Fujii, M; Konishi, T; Nagamoto, H; Shibasaki, Y; Ueno, T; Yurikusa, T; Zenda, S, 2019)
" The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3."2.84Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study. ( Beppu, T; Fujii, M; Fujii, T; Fujimoto, Y; Hasegawa, Y; Hirano, S; Iwae, S; Kojima, H; Matsushima, Y; Matsuura, K; Monden, N; Naka, Y; Nishimori, H; Ogawa, T; Okami, K; Ota, I; Sasaki, K; Tahara, M; Takahashi, S; Tanaka, K; Ueda, S; Ueda, T; Yokota, T, 2017)
"60 Patients diagnosed with Head & Neck cancer recruited for concurrent chemo-radiotherapy were assigned in a double blind fashion into 2 groups using computer based 1:1 ratio randomization."2.84Rebamipide gargle in preventive management of chemo-radiotherapy induced oral mucositis. ( Chaitanya, B; Chhaparwal, Y; Fernandes, D; Pai, KM; Yathiraj, PH, 2017)
"Aphthous stomatitis is induced by chemotherapy and radiotherapy."2.61[Development of Hospital Formulations Based on Medical Need]. ( Hanawa, T; Kawano, Y, 2019)
"Oral mucositis is a significant side effect in cancer treatment."1.51Rebamipide-containing Film Using Chitosan and HPMC for Oral Mucositis Induced by Cancer Chemotherapy. ( Makino, K; Takeuchi, I; Togo, C, 2019)
"Irsogladine maleate (IM) is a drug with gastric mucosal protective properties."1.48[Development of "Patient Friendly Formulations" to Counter the Side Effects of Cancer Chemotherapy]. ( Hanawa, T; Kawano, Y; Satoh, M, 2018)
"Oral mucositis is one of the most common side effects induced by cancer therapy, and the prevention or rapid treatment of the symptoms of oral mucositis can improve patients' quality of life and reduce the need for treatment interruption."1.48Therapeutic efficacy of rebamipide-loaded PLGA nanoparticles coated with chitosan in a mouse model for oral mucositis induced by cancer chemotherapy. ( Kamiki, Y; Makino, K; Takeuchi, I, 2018)
" The pretreatment period, dosing frequency, and dose dependency of rebamipide were examined."1.46Intra-oral administration of rebamipide liquid prevents tongue injuries induced by X-ray irradiation in rats. ( Nakashima, T; Sakurai, K; Uematsu, N, 2017)
"Chemotherapy-induced oral mucositis (CIOM) is a severe adverse event resulting from cancer chemotherapy."1.42[Efficacy of Rebamipide Gargle against Chemotherapy-induced Oral Mucositis]. ( Nakamura, K; Nakamura, M; Onikubo, T; Shinohara, A, 2015)

Research

Studies (15)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's15 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Kawano, Y3
Hanawa, T3
Takeuchi, I2
Togo, C1
Makino, K2
Yokota, T1
Ogawa, T1
Takahashi, S1
Okami, K1
Fujii, T1
Tanaka, K1
Iwae, S1
Ota, I1
Ueda, T1
Monden, N1
Matsuura, K1
Kojima, H1
Ueda, S1
Sasaki, K1
Fujimoto, Y1
Hasegawa, Y1
Beppu, T1
Nishimori, H1
Hirano, S1
Naka, Y1
Matsushima, Y1
Fujii, M2
Tahara, M1
Ishii, N1
Sakai, H1
Hayashi, S1
Akizuki, N1
Komoda, M1
Chaitanya, B1
Pai, KM1
Yathiraj, PH1
Fernandes, D1
Chhaparwal, Y1
Satoh, M1
Kamiki, Y1
Ueno, T1
Zenda, S1
Konishi, T1
Yurikusa, T1
Shibasaki, Y1
Nagamoto, H1
Nakashima, T3
Sako, N1
Matsuda, T1
Uematsu, N3
Sakurai, K3
Ishida, T1
Enami, A1
Masuda, N1
Yamamura, J1
Mizutani, M1
Yasojima, H1
Shikata, A1
Masaoka, M1
Takada, S1
Bamba, N1
Yamamoto, M1
Abe, M1
Makihara, K1
Shinohara, A1
Nakamura, M1
Onikubo, T1
Nakamura, K1
Shibamori, M1
Sato, M1
Sato, A1
Yamamura, Y1
Sasabe, H1
Umehara, K1
Yajima, R1
Imaoka, F1
Wako, T1
Kuroda, Y1
Matsumoto, K1
Kizu, J1
Katayama, S1
Kabeya, M1
Ina, K1
Yuasa, S1
Kikuchi, F1
Tajiri, C1
Kato, T1
Hibi, S1
Minagawa, Y1
Furuta, R1
Kayukawa, S1
Kataoka, T1
Kawai, M1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer[NCT02085460]Phase 294 participants (Actual)Interventional2014-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Incidence of Grade ≥3 Oral Mucositis Determined by Clinical Examination and Assessed by Central Review According to the Common Terminology Criteria of Adverse Events (CTCAE) Version 3.0.

Investigators who had undergone specific training assessed the severity of oral mucositis twice every week. To evaluate the severity of oral mucositis objectively, the clinical findings of the oral mucosa as well as functional disorders and symptomatic aspects were recorded in the Oral Mucositis Assessment Sheet by each investigator. Photographic documentation of the oral mucosa was also submitted by each investigator, 3 days before or 57 days after initiation of chemoradiotherapy, or at the time of withdrawal. The Oral Mucositis Assessment Sheets and photographic documentation were then reviewed by the Oral Mucositis Evaluation Committee to grade the severity of oral mucositis according to the CTCAE 3.0.z (NCT02085460)
Timeframe: 77 days

Interventionpercentage of participants (Number)
2% Rebamipide Liquid29.0
4% Rebamipide Liquid25.0
Placebo38.7

Number of Subjects Who Did Not Developed Grade ≥3 Mucositis

Day 1 was defined as the start of chemotherapy. (NCT02085460)
Timeframe: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77

,,
Interventionparticipants (Number)
Day 1Day 8Day 15Day 22Day 29Day 36Day 43Day 50Day 57Day 64Day 71Day 77
2% Rebamipide Liquid3129272523201817121186
4% Rebamipide Liquid313130292520181816151311
Placebo3130292323191615131188

Reviews

1 review available for opc 12759 and Stomatitis

ArticleYear
[Development of Hospital Formulations Based on Medical Need].
    Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2019, Volume: 139, Issue:10

    Topics: Alanine; Cellulose; Chemical Phenomena; Drug Compounding; Drug-Related Side Effects and Adverse Reac

2019

Trials

4 trials available for opc 12759 and Stomatitis

ArticleYear
Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study.
    BMC cancer, 2017, 05-05, Volume: 17, Issue:1

    Topics: Adult; Aged; Alanine; Chemoradiotherapy; Dose-Response Relationship, Drug; Double-Blind Method; Fema

2017
Rebamipide gargle in preventive management of chemo-radiotherapy induced oral mucositis.
    Oral oncology, 2017, Volume: 72

    Topics: Adult; Aged; Alanine; Case-Control Studies; Chemoradiotherapy; Double-Blind Method; Female; Head and

2017
The post hoc analysis comparing the severity grades of chemoradiotherapy-induced oral mucositis scored between the central and local assessors in a multicenter, randomized controlled trial of rebamipide for head and neck cancer.
    International journal of clinical oncology, 2019, Volume: 24, Issue:3

    Topics: Aged; Alanine; Chemoradiotherapy; Double-Blind Method; Female; Head and Neck Neoplasms; Humans; Male

2019
[Pilot study on clinical effects of rebamipide gargle against oral mucositis induced by fluoropyrimidines].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2011, Volume: 38, Issue:7

    Topics: Alanine; Antimetabolites, Antineoplastic; Colonic Neoplasms; Fluorouracil; Humans; Mouthwashes; Pilo

2011

Other Studies

10 other studies available for opc 12759 and Stomatitis

ArticleYear
Rebamipide-containing Film Using Chitosan and HPMC for Oral Mucositis Induced by Cancer Chemotherapy.
    Anticancer research, 2019, Volume: 39, Issue:12

    Topics: Alanine; Antineoplastic Agents; Chitosan; Delayed-Action Preparations; Humans; Hypromellose Derivati

2019
Effects of a Rebamipide Mouthwash on Stomatitis Caused by Cancer Chemotherapy-Evaluation of the Efficacy by Patients Themselves.
    Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2017, Aug-01, Volume: 137, Issue:8

    Topics: Aged; Aged, 80 and over; Alanine; Antineoplastic Agents; Colorectal Neoplasms; Humans; Lung Neoplasm

2017
[Development of "Patient Friendly Formulations" to Counter the Side Effects of Cancer Chemotherapy].
    Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2018, Volume: 138, Issue:2

    Topics: Administration, Oral; Alanine; Animals; Antineoplastic Agents; Cell Communication; Cyclic AMP; Disea

2018
Therapeutic efficacy of rebamipide-loaded PLGA nanoparticles coated with chitosan in a mouse model for oral mucositis induced by cancer chemotherapy.
    Colloids and surfaces. B, Biointerfaces, 2018, Jul-01, Volume: 167

    Topics: Alanine; Animals; Anti-Ulcer Agents; Chitosan; Coated Materials, Biocompatible; Drug Liberation; Flu

2018
Novel submicronized rebamipide liquid with moderate viscosity: significant effects on oral mucositis in animal models.
    Biological & pharmaceutical bulletin, 2014, Volume: 37, Issue:4

    Topics: Administration, Oral; Alanine; Animals; Anti-Ulcer Agents; Cautery; Disease Models, Animal; Drug Car

2014
[Therapeutic effect of rebamipide for oral mucositis associated with FEC therapy for breast cancer].
    Gan to kagaku ryoho. Cancer & chemotherapy, 2014, Volume: 41, Issue:11

    Topics: Adult; Aged; Alanine; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Cyclophospha

2014
[Efficacy of Rebamipide Gargle against Chemotherapy-induced Oral Mucositis].
    Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2015, Volume: 135, Issue:8

    Topics: Adult; Aged; Aged, 80 and over; Alanine; Antineoplastic Agents; Antioxidants; Dinoprostone; Epoprost

2015
Rebamipide does not interfere with the antitumor effect of radiotherapy or chemotherapy in human oral tumor-bearing nude mice.
    Journal of pharmacological sciences, 2015, Volume: 129, Issue:1

    Topics: Alanine; Animals; Antineoplastic Agents; Antioxidants; Carcinoma, Squamous Cell; Cell Line, Tumor; C

2015
[Basic Studies on the Stability of Flavored Oral Solutions of Rebamipide].
    Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2015, Volume: 135, Issue:12

    Topics: Administration, Oral; Alanine; Anti-Ulcer Agents; Drug Stability; Humans; Quinolones; Stomatitis

2015
Intra-oral administration of rebamipide liquid prevents tongue injuries induced by X-ray irradiation in rats.
    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2017, Volume: 25, Issue:7

    Topics: Administration, Oral; Alanine; Animals; Anti-Ulcer Agents; Humans; Male; Quinolones; Rats; Rats, Spr

2017