NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051220010

Registered date:22/04/2022

Efficacy and safety of Ibuprofen gargle for oral lichen planus: a phase II, open-label, long-term, extension trial.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedoral lichen planus
Date of first enrollment23/06/2022
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)Ibuprofen gargle

Outcome(s)

Primary OutcomeOccurrence of adverse event.
Secondary OutcomeChange in Visual Analog Scale (VAS) values before, 5 minutes after, and 15 minutes after the first use of ibuprofen gargle after Day 1. Changes in the Patient Reported Oral Mucositis Symptom scale (PROMS scale). Time to onset of effect of study drug. Duration of effect of study drug. Overall daily efficacy Number of times used per day

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria(1) Patients who finished double-blind placebo-controlled phase II clinical trial of Ibuprofen in patients with oral lichen planus (OLP). (2) Patients who wish to continue to receive ibuprofen-containing products from double-blind placebo-controlled phase II clinical trial (3) Patients with written informed consent.
Exclude criteria(1) Patients who have met the termination criteriaover two days for the double-blind placebo-controlled phase II clinical trial. (2) Patients who have been diagnosed with Dementia, psychiatric symptoms, drug addiction, alcoholism, etc, have been identified by an attending investigator who neither fully comprehends nor cooperates. (3) Pregnant women or breast-feeding women. (4) Patients who are not appropriate to participate to the trial.

Related Information

Contact

Public contact
Name Kazuhiro Yamamoto
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6659
E-mail yamakz@med.kobe-u.ac.jp
Affiliation Kobe University Hospital
Scientific contact
Name Yasumasa Kakei
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Hyogo Japan 650-0017
Telephone +81-78-382-6213
E-mail ykakei@med.kobe-u.ac.jp
Affiliation Kobe University Hospital