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Phase I/II study of Ibuprofen gargle for chemotherapy or chemo-radiation therapy induced mucositis oral

Phase I/II study of Ibuprofen gargle for chemotherapy or chemo-radiation therapy induced mucositis oral - Phase I/II study of Ibuprofen gargle for mucositis oral

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014433
Enrollment
20
Registered
2014-07-01
Start date
2014-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignancy

Interventions

Sponsors

Kobe University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with age: <= 20 years 2.Patient will provide written informed consent and authorization to release personal health information. 3.Inpatients.

Exclusion criteria

Exclusion criteria: 1.No known CNS metastasis. 2.Impairment of GI function or GI disease 3.Other concurrent severe and/or uncontrolled concomitant medical conditions 4.Impaired cardiac function or clinically significant heart disease, including any one of the following: _Angina pectoris within 3 months _Acute myocardial infarction within 3 months _Other clinically significant heart disease 5.No exist the aspirin-induced asthma. 6.No known hypersensitivity to any component of study regimen. 7.No use of zidovudine 8.Drug dependence disease and alcoholism 9.Patients unwilling or unable to comply with the protocol 10.No use of aspirin 11.Under the pregnancy or the nursing 12.Women of child-bearing potential who are pregnant. 13.No participate in other clinical trials. 14.Without participating in a similar examination clinical trial 15.Patients judged inappropriate for this study by physicians.

Design outcomes

Primary

MeasureTime frame
Safety: Adverse events and serious adverse drug reactions, abnormal changes in hematology and chemistry lab values, specifically those associated with hepatic and renal function; and assessment of physical examinations, vital signs

Secondary

MeasureTime frame
1.pain score 2.Improvement level of feeding, taking medicine, drinking water, conversation, and sleep

Countries

Japan

Contacts

Public ContactTakeshi Ioroi

Kobe University Hospital Department of Hospital Pharmacy

chiken@med.kobe-u.ac.jp078-382-6669

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026