Head and Neck CancerPhase 2NCT02085460
A 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
A Phase 2 study testing 2% Rebamipide liquid and 4% Rebamipide liquid in people with Head and Neck Cancer, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- 2% Rebamipide liquid and 4% Rebamipide liquid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 5 sitesJapan
- Study dates
- Mar 2014to Aug 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
- Patients complicated with autoimmune disease
- Patients requiring continuous systemic administration of glucocorticoid
- Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant
- Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy
- Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds
- Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Kanto Region
Study site
Kinki Region
Study site
Tohoku Region
About this study
Official title: 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
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Placebo, 2% Rebamipide liquid, 4% Rebamipide liquid
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2% Rebamipide liquidDrug
4% Rebamipide liquidDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 6 times daily Receives: Drug: Placebo |
| 2% Rebamipide liquid | Experimental | 6 times daily Receives: Drug: 2% Rebamipide liquid |
| 4% Rebamipide liquid | Experimental | 6 times daily Receives: Drug: 4% Rebamipide liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 77 days
Secondary outcomes (1)
Number of Subjects Who Did Not Developed Grade ≥3 Mucositis
Day 1 was defined as the start of chemotherapy.
Measured: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun-ichi Hashimoto, PhD, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085460
- Sponsor's protocol ID
- 037-12-001
- Other IDs
- JapicCTI-142467
- Status last verified
- Sep 2021
- First submitted
- 11 Mar 2014
- Last updated
- 18 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30426268Yokota 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.
PubMed 28476132
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02085460
- Acronym / sponsor ID
- 037-12-001
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo6 times daily |
| 2% Rebamipide liquid | Experimental | Drug: 2% Rebamipide liquid6 times daily |
| 4% Rebamipide liquid | Experimental | Drug: 4% Rebamipide liquid6 times daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | Placebo |
| 2% Rebamipide liquid | Drug | 2% Rebamipide liquid |
| 4% Rebamipide liquid | Drug | 4% Rebamipide liquid |
Primary outcome
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.
Time frame: 77 days
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
1 secondary outcome
Number of Subjects Who Did Not Developed Grade ≥3 Mucositis
Time frame: Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30426268Ueno 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.
- Derived from this study: PubMed 28476132Yokota 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-ichi Hashimoto, PhD study director
Otsuka Pharmaceutical Co., Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2% Rebamipide liquid and 4% Rebamipide liquid in people with Head and Neck Cancer, run by Otsuka Pharmaceutical Co., Ltd. at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 77 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085460, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.