Study on the time course effectiveness of Rupatadine Fumarate

JRCT ID: jRCTs031190058

Registered date:23/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic urticaria
• Date of first enrollment: 01/08/2019
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Evaluation 1: The first oral administration
A 10mg of the test drug should be administered orally at the first time to be observed the skin eruption (erythema score >= 2 and wheal score >= 2 ) in the area that can be taken pictures.
Evaluation 2: Usual dose oral administration
From the first dose, a 10mg of the test drug should be administered orally once daily for 14 days.
Evaluation 3: Increased dose oral administration
The test drug should be administered orally in 20mg dose once daily for 14 days on the patients with had been judged "not effective clinically" at the end of the first study duration for 14 days.

Outcome(s)

• Primary Outcome: Time to the skin eruption disappearance from the first oral administration of a test drug after observation of the skin eruption (erythema score < 1 and wheal score 0).

Secondary Outcome

1) Time to score 0 of the itch NRS from the first oral administration of the test drug.
2) Change in itch score.
3) Evaluation of the effectiveness of both 10mg once daily for 14 days, and 20mg once daily for 14 days.
4) Change in urticaria severity score.
5) Change in urticaria symptom score (urticaria NRS).
6) Relationship between symptoms (erythema, wheal and itch) and factors that influence on improvement of symptoms.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1) Subjects who were diagnosed with chronic urticaria.
2) Subjects with the skin eruption (erythema score >= 2 and wheal score >= 2 ).
3) Subjects with the skin eruption in the area where photos can be taken.
4) Subjects who were 20 years old or older, less than 65 years old when registered.
5) Subjects with written consent after having informed of the study contents.

Exclude criteria

1) Subjects with hypersensitivity to study drug (correspond to contraindications) .
2) Subjects who were treated with drugs except for the antihistamine (histamine H1 receptor antagonist) for chronic urticaria.
3) Subjects under treatment for allergic rhinitis.
4) Subjects whom the doctor judged as inappropriate for the study.
5) Pregnant or possibly pregnant women, breast feeding women, or women who wish to become pregnant during study period.

Related Information

• Primary Sponsor: Kitahara Hiroto
• Secondary Sponsor: Kawashima Makoto
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma Corporation,Teikoku Seiyaku Co.,Ltd.