NCT02085460

Brief Summary

To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

October 18, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

March 11, 2014

Results QC Date

March 11, 2021

Last Update Submit

September 22, 2021

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    77 days

Secondary Outcomes (1)

  • Number of Subjects Who Did Not Developed Grade ≥3 Mucositis

    Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77

Study Arms (3)

Placebo

PLACEBO COMPARATOR

6 times daily

Drug: Placebo

2% Rebamipide liquid

EXPERIMENTAL

6 times daily

Drug: 2% Rebamipide liquid

4% Rebamipide liquid

EXPERIMENTAL

6 times daily

Drug: 4% Rebamipide liquid

Interventions

PlaceboDRUG
Placebo
2% Rebamipide liquidDRUG
2% Rebamipide liquid
4% Rebamipide liquidDRUG
4% Rebamipide liquid

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy.
  • Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions.
  • Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx
  • Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx
  • Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Patients who are able to hold fluid in the mouth
  • Patients who are able to swallow the investigational medicinal product (IMP)
  • Patients expected to survive for at least 3 months
  • Patients who have given written informed consent in person
  • Patients who can stay at or visit the hospital for scheduled examinations and observations
  • Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration

You may not qualify if:

  • Patients with primary malignant tumors other than head and neck cancer.
  • Patients with symptomatic viral, bacterial, or fungal infection
  • Patients with serious renal impairment
  • Patients with distant metastasis
  • Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc)
  • Patients with any of the following laboratory test results:
  • Neutrophil count: \<1500 L
  • Platelet count: \<75000 L
  • Hemoglobin: \<10.0 g/L
  • Aspartate aminotransferase (AST): \>3 times the upper limit of the reference value at the trial site
  • Alanine aminotransferase (ALT): \>3 times the upper limit of the reference value at the trial site
  • Serum bilirubin: \>1.5 times the upper limit of the reference value at the trial site
  • Serum albumin: \<3.0 g/dL
  • Serum creatinine: \>1.5 the upper limit of the reference value at the trial site
  • Creatinine clearance : \<30 mL/min
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

Related Publications (2)

  • Ueno T, Zenda S, Konishi T, Yurikusa T, Shibasaki Y, Nagamoto H, Fujii M. 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. Int J Clin Oncol. 2019 Mar;24(3):241-247. doi: 10.1007/s10147-018-1355-7. Epub 2018 Nov 13.

    PMID: 30426268BACKGROUND

  • Yokota T, Ogawa T, Takahashi S, Okami K, Fujii T, Tanaka K, Iwae S, Ota I, Ueda T, Monden N, Matsuura K, Kojima H, Ueda S, Sasaki K, Fujimoto Y, Hasegawa Y, Beppu T, Nishimori H, Hirano S, Naka Y, Matsushima Y, Fujii M, Tahara M. 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 May 5;17(1):314. doi: 10.1186/s12885-017-3295-4.

    PMID: 28476132DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., LTD.
CL_OPCJ_RDA_Team@otsuka.jp
+81-3-6361-7366

Study Officials

  • Jun-ichi Hashimoto, PhD

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 12, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 18, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-09

Locations

JP(5)