UMIN-CTR Clinical Trial

Public title

Study of optimal treatment duration with antihistamine in idiopathic urticaria patients

Acronym

Urticaria Dose optimized trial (SOLIDARITIE)

Scientific Title

Study of optimal treatment duration with antihistamine in idiopathic urticaria patients

Scientific Title:Acronym

Urticaria Dose optimized trial (SOLIDARITIE)

Region

Japan

Condition

Idiopathic urticaria

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To study the optimal duration of treatment with antihistamine after relief of symptoms/signs in patients with idiopathic urticaria, we compare immediately stopping treatment with 4 weeks prolonged treatment after the relief of symptoms/signs in patients with idiopathic urticaria by antihistamine.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Cumulative recurrence rate at 3 months after relief of urticaria symptoms (signs)

Key secondary outcomes

1. Cumulative recurrence rate at 4 and 8 weeks after the relief of urticaria symptoms(signs)
2. Safety

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Four week-treatment with fexofenadine (120 mg/day) group

Interventions/Control_2

Untreatment observation group

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with idiopathic urticaria
1. Symptoms/signs free of urticaria for at least 48 hrs at the randomization
2. Symptom/signs are resolved in the period of 2-6 weeks from the onset of uritcaria
3. Not less than 20 years old (no upper limit)
4. Written informed consent

Key exclusion criteria

1. Pregnant or lactating women or women of child bearing potential not using contraception
2. Patients with a history of hypersensitivity to fexofenadine hydrochloride
3. Patients who use medications that interfere with the efficacy evaluation (e.g., other antihistamines, drugs with anti-allergy action, systemic steroids etc.)
4. Others whom the physician judges are not suitable as subjects

Target sample size

120

Name of lead principal investigator

1st name	Michichiro
Middle name
Last name	hide

Organization

Hiroshima University

Division name

Department of Dermatology, Graduate School of Biomedical and Health Sciences

Zip code

734-8553

Address

1-2-3 Kasumi Minami-ku Hiroshima 734-8551

TEL

0822575235

Email

ed1h-w1de-road@hiroshima-u.ac.jp

Name of contact person

1st name	Motoaki
Middle name
Last name	Inoue

Organization

Clinical Research Support Center Kyusyu

Division name

Secretariat

Zip code

734-8551

Address

Kasumi, Minami-ku

TEL

092-631-2920

Homepage URL

http://www.cres-kyusyu.or.jp

Email

inoue@cres-kyushu.or.jp

Institute

West Japan Urticaria Therapy Study Group

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyusyu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Hiroshima University Integrated Clinical Research Support Center

Address

1-2-3

Tel

0822571732

Email

iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

05

Month

23

Day

URL releasing protocol

https://www.umin.ac.jp/ctr/index-j.htm

Publication of results

Unpublished

URL related to results and publications

https://www.umin.ac.jp/ctr/index-j.htm

Number of participants that the trial has enrolled

93

Results

1. Less patients (70%) in the treated group suffered from recurrences than in the control group (90%).
2. Urticaria scores of patients in the last week of the study, and a number of patients who were either suffering from symptoms or taking medications in the treated group were lower than those in the control group.
3. No relation was observed between the recurrence rate and time to the treatment, time to be symptom-free from the onset of urticaria, and severity of urticaria before the treatment.

Results date posted

2022

Year

06

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

All subjects involved in this study were
1. aged 20 years or more
2. patients with spontaneous urticaria not more than 6 weeks and not less than two weeks previously
3. being free of urticaria symptoms for two days or longer on the treatment with an antihistamine

Participant flow

Following the eligibility evaluation and informed consent, patients were randomized by a computer-generated allocation code into two arms. Subjects in arm 1, the treated group, received oral fexofenadine 120 mg per day for four weeks (period 1) and were followed up regarding clinical symptoms for 8 weeks (period 2). Subjects in arm 2, the control group, stopped medications on the day of enrolment and were followed up in both period 1 and 2 for 12 weeks in total. If urticaria of the patient recurred, restarting treatment by any medications was permitted from that point.

Adverse events

Tree subjects suffered from adverse events during the study; one from common cold, one from eczema, and one from pollakiuria and dysuria.

Outcome measures

The primary objective;
the effect of four weeks additional administration of fexofenadine on the recurrence of patients with spontaneous urticaria in the period of eight weeks observation after the treatment.

The secondary objective;
1. the recurrence rate of urticaria during the study periods
2. changes of urticaria scores until the end of study (12 weeks from the enrolment)
3. relations of recurrence to clinical characteristics before the enrollment.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2007

Year

10

Month

22

Day

Date of IRB

2007

Year

11

Month

05

Day

Anticipated trial start date

2007

Year

12

Month

01

Day

Last follow-up date

2010

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

05

Month

23

Day

Last modified on

2022

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001095

Single case data URL

Value
https://center6.umin.ac.jp/ice/1095