Chronic Idiopathic UrticariaPhase 4NCT00536380

Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)

A Phase 4 study testing 5-mg Desloratadine, 10-mg Desloratadine and 20-mg Desloratadine in people with Chronic Idiopathic Urticaria, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Idiopathic Urticaria
What is being tested?: 5-mg Desloratadine, 10-mg Desloratadine and 20-mg Desloratadine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 314 participants
Where: No sites listed yet
Study dates: Sep 2007to Apr 2009
Phase: Phase 4
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must satisfy the following criteria before being enrolled/randomized into the study.
Subject must demonstrate willingness to participate in the study.
Subject must be 18 to 75 years of age, of either gender, and any race.
Subject must have had this episode of chronic idiopathic urticaria for at least 6 weeks or more, and has been dosing with a "2nd generation antihistamine (AH)" for 2 weeks or longer, and
Subject's current episode of urticaria is sufficiently symptomatic at the Screening Visit to qualify for this study, in the opinion of the investigator.
Subject has a Baseline Week (entry period) UAS between 10 and 30 inclusive.

Show all 14Show fewer

Patient must understand and be willing to assess and record symptom scores.
Has voluntarily signed a written informed consent.
Subjects must confirm that all prior medication washout times have been observed.
Subject must confirm that he/she is practicing adequate contraception:
Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (i.e., women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, ie, double-barrier method (eg, male or female condom and spermicide), oral contraceptive, Depo-Provera, NuvaRing, contraceptive transdermal patch, etc, for female subjects of childbearing potential prior to screening and during the study. Women of childbearing potential should be counseled in the appropriate use of birth control while in the study. Vasectomy or tubal ligation is considered a single barrier. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods if they become sexually active while participating in the study.
If subject is a female volunteer of childbearing potential, she must have a negative urine pregnancy test at Screening/Visit 1.
Subjects must be free of any clinically relevant disease other than chronic idiopathic urticaria (CIU) that would, in the principal investigator's and/or sponsor's opinion, interfere with the conduct of the study or study evaluations.
Subjects must be able to adhere to the dosing and visit schedules and agree to record symptom severity scores, medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary.

Who cannot join

Is a female who is pregnant, or intends to become pregnant during the study.
Is nursing, or intends to be nursing during the study or within 90 days after study completion.
Has not observed the designated washout periods for any of the prohibited medications.
Has used any investigational product within 30 days prior to enrollment.
Have any of the following clinical conditions:
Symptomatic seasonal or perennial allergic rhinitis.

Show all 24Show fewer

Asthma not controlled by short-acting beta-2 agonists used as necessary.
The presence of permanent severe diseases, especially those affecting the immune system, except urticaria.
The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).
History of/or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
History of/or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
Evidence of/or a history of significant renal disease.
Evidence of/or a history of significant hepatic disease.
Presence of cancer which requires chemotherapy or radiation therapy.
Presence of glaucoma.
Presence of urinary bladder neck obstruction with emptying difficulties.
Presence of acute urticaria .
Body mass index (BMI) > 35
Has any clinically significant deviation from the appropriate reference range in the physical examination, or other clinical evaluation that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Is participating in any other clinical study(ies).
Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
Is allergic to or has a history of hypersensitivity to the study drug (desloratadine), to any of its excipients, or to loratadine.
Has the rare hereditary problem of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.

About this study

Official title: A Study of the Efficacy, Safety, and Quality of Life (QOL) in Patients With Chronic Idiopathic Urticaria Dosed With AERIUS Tablets (Desloratadine 5 mg, 10 mg, or 20 mg Once Daily)

This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.

Conditions: Chronic Idiopathic Urticaria
Being tested: 5-mg Desloratadine, 10-mg Desloratadine, 20-mg Desloratadine
Medical subject headings: Chronic Urticaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5-mg DesloratadineDrug
Also called SCH 34117, Clarinex, Aerius
5-mg desloratadine tablets, once daily for four weeks.
10-mg DesloratadineDrug
Also called SCH 34117, Clarinex, Aerius
10-mg desloratadine tablets, once daily for four weeks.
20-mg DesloratadineDrug
Also called SCH 34117, Clarinex, Aerius
20-mg desloratadine tablets, once daily for four weeks.

Study groups in NCT00536380
Study group	Role	What they receive
5-mg Desloratadine	Experimental	5-mg Desloratadine once daily Receives: Drug: 5-mg Desloratadine
10-mg Desloratadine	Experimental	10-mg Desloratadine once daily Receives: Drug: 10-mg Desloratadine
20-mg Desloratadine	Experimental	20-mg Desloratadine once daily Receives: Drug: 20-mg Desloratadine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg
The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was "reflective", covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.
Measured: Baseline and 4 treatment weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Apr 2009

First posted27 Sep 2007 (estimated)
Study startSep 2007
Primary completionApr 2009
Study completionApr 2009

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.
Other trials for Chronic Idiopathic UrticariaStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 314 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00536380
Sponsor's protocol ID: P04849
Status last verified: Feb 2022
First submitted: 26 Sep 2007
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Active, not recruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria

All Chronic Idiopathic Urticaria trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Efficacy, Safety, and Quality of Life (QOL) in Patients With Chronic Idiopathic Urticaria Dosed With AERIUS Tablets (Desloratadine 5 mg, 10 mg, or 20 mg Once Daily)
ClinicalTrials.gov ID: NCT00536380
Acronym / sponsor ID: P04849
Conditions: Chronic Idiopathic Urticaria
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 314 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 27 Sep 2007 (estimated)
Results: Posted 3 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
5-mg Desloratadine	Experimental	Drug: 5-mg Desloratadine5-mg Desloratadine once daily
10-mg Desloratadine	Experimental	Drug: 10-mg Desloratadine10-mg Desloratadine once daily
20-mg Desloratadine	Experimental	Drug: 20-mg Desloratadine20-mg Desloratadine once daily

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Subjects must satisfy the following criteria before being enrolled/randomized into the study.
Subject must demonstrate willingness to participate in the study.
Subject must be 18 to 75 years of age, of either gender, and any race.
Subject must have had this episode of chronic idiopathic urticaria for at least 6 weeks or more, and has been dosing with a "2nd generation antihistamine (AH)" for 2 weeks or longer, and
Subject's current episode of urticaria is sufficiently symptomatic at the Screening Visit to qualify for this study, in the opinion of the investigator.

Key exclusion criteria (24 listed)

Is a female who is pregnant, or intends to become pregnant during the study.
Is nursing, or intends to be nursing during the study or within 90 days after study completion.
Has not observed the designated washout periods for any of the prohibited medications.
Has used any investigational product within 30 days prior to enrollment.
Have any of the following clinical conditions:

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
5-mg DesloratadineAlso: SCH 34117, Clarinex, Aerius5-mg desloratadine tablets, once daily for four weeks.	Drug	5-mg Desloratadine
10-mg DesloratadineAlso: SCH 34117, Clarinex, Aerius10-mg desloratadine tablets, once daily for four weeks.	Drug	10-mg Desloratadine
20-mg DesloratadineAlso: SCH 34117, Clarinex, Aerius20-mg desloratadine tablets, once daily for four weeks.	Drug	20-mg Desloratadine

Primary outcome

Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg
Time frame: Baseline and 4 treatment weeks
The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was "reflective", covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.

Results and safety

Results posted to the registry on 3 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5-mg Desloratadine	106	94
10-mg Desloratadine	104	95
20-mg Desloratadine	104	94

Primary outcome: Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg

Time frame: Baseline and 4 treatment weeks. Least squares mean (Standard Error). Unit: Units on a scale

Measure	5-mg Desloratadine n = 104	20-mg Desloratadine n = 100	10-mg Desloratadine n = 104
Change from Baseline in UAS	-1.0 (0.12)	-1.0 (0.12)	-1.1 (0.12)
Baseline UAS (mean +/- standard deviation)	2.9 (0.82)	2.8 (0.74)	2.9 (0.77)

5-mg Desloratadine vs 20-mg Desloratadine: p = 0.721, ANCOVA

Population analysed: Intent to treat population

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
5-mg Desloratadine	0 of 106 (0%)	5 of 106 (4.7%)	Not reported
10-mg Desloratadine	1 of 104 (1%)	4 of 104 (3.8%)	Not reported
20-mg Desloratadine	1 of 104 (1%)	6 of 104 (5.8%)	Not reported

Limitations and caveats (from the sponsor): Due to poor enrollment (even after extending the enrollment period), only 314 participants (not 600 participants) were randomized to the study and hence the study was inconclusive due to the lacking of statistical power and robustness.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Chronic Idiopathic Urticaria

Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
Active, not recruitingEarly Phase 1
A Trial of HRS-3095 in Healthy Volunteers
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 5-mg Desloratadine, 10-mg Desloratadine and 20-mg Desloratadine in people with Chronic Idiopathic Urticaria, run by Organon and Co.

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 14 inclusion and 24 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 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 3 May 2010). 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?

Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg (time frame: Baseline and 4 treatment weeks). 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 NCT00536380.

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 23 May 2024.