UrticariaPhase 4ATTITUDNCT00783354
A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)
A Phase 4 study testing desloratadine in people with Urticaria and Chronic Idiopathic Urticaria, run by Organon and Co.
Trial summary
This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urticaria, Chronic Idiopathic Urticaria
- What is being tested?
- desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2003to 1 Apr 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >= 18 years of age
- Women of childbearing potential must have a negative urine pregnancy test at Visit 1 (Day 1) and must be using an acceptable method of birth control during the study.
- Subjects must be in general good health; ie, they must be free of any clinically significant disease (other than CIU) that would interfere with study evaluations.
- Subjects must understand and be able to adhere to visit schedules, and agree to complete the questionnaires and a diary.
- Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1.
Who cannot join
- Women who are pregnant or nursing.
- Subjects who used any investigational drug in the last 30 days prior to Visit 1
- Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
- Subjects who have been treated with any investigational antibodies for asthma or allergic rhinitis in the 90 days prior to Baseline.
- Subjects who have been treated with intra-muscular or intra-articular corticosteroids in the 90 days prior to Baseline.
- Subjects with urticaria that is primarily due to physical urticaria or other known etiology, except dermographism.
Show all 13Show fewer
- Subjects treated by immunosuppressive drugs.
- Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit 1.
- Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
- Subjects previously randomized into this study.
- Subjects who have any clinically significant metabolic, cardiovascular, immunological, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.
- Subjects with a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.
- Subjects with a history of noncompliance with medications or treatment protocols.
About this study
Official title: A Pilot, Multicenter, Double-blind Randomized Study for Comparison of Aerius® "Continuous Treatment" Versus Aerius® "PRN Regimen" on Chronic Idiopathic Urticaria Patient Quality of Life
This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms).
- Conditions
- Urticaria, Chronic Idiopathic Urticaria
- Being tested
- desloratadine
- Medical subject headings
- Urticaria, Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desloratadineDrug
Also called Aerius, SCH 34117
Patients received desloratadine 5 mg daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (Placebo) in case of symptoms for 2 months.
desloratadineDrug
Also called Aerius, SCH 34117
Patients received Placebo daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (desloratadine 5 mg) in case of symptoms for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Treatment | Active comparator | Not described Receives: Drug: desloratadine |
| PRN regimen | Experimental | Not described Receives: Drug: desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score.
Measured: 2 months
Secondary outcomes (9)
Estimation of disease free period after 3 months of daily treatment.
Measured: 2 months
Average usage of rescue medication
Measured: 2 months
Change from Visit 2 in pruritus symptom score assessed by the patient.
Measured: 2 months
% of patients free of symptoms 2 months after Visit 4
Measured: 2 months
Changes from Visit 2 of overall conditions of CIU
Measured: 2 months
Discontinuation due to treatment failure
Measured: 2 months
Investigator's assessment of response to therapy
Measured: 2 months
Quality of disease control
Measured: 2 months
Average consumption of treatment between Visit 2 and Visit 5
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start1 Apr 2003
- Primary completion1 Feb 2004
- Study completion1 Apr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783354
- Sponsor's protocol ID
- P03147
- Acronym
- ATTITUD
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Grob JJ, Auquier P, Dreyfus I, Ortonne JP. How to prescribe antihistamines for chronic idiopathic urticaria: desloratadine daily vs PRN and quality of life. Allergy. 2009 Apr;64(4):605-12. doi: 10.1111/j.1398-9995.2008.01913.x. Epub 2008 Dec 30.
PubMed 19133920
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multicenter, Double-blind Randomized Study for Comparison of Aerius® "Continuous Treatment" Versus Aerius® "PRN Regimen" on Chronic Idiopathic Urticaria Patient Quality of Life
- ClinicalTrials.gov ID
- NCT00783354
- Acronym / sponsor ID
- ATTITUD / P03147
- Conditions
- Urticaria, Chronic Idiopathic Urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2003 (actual)
- Primary completion
- 1 Feb 2004 (actual)
- Study completion
- 1 Apr 2004 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Treatment | Active comparator | Drug: desloratadine |
| PRN regimen | Experimental | Drug: desloratadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >= 18 years of age
- Women of childbearing potential must have a negative urine pregnancy test at Visit 1 (Day 1) and must be using an acceptable method of birth control during the study.
- Subjects must be in general good health; ie, they must be free of any clinically significant disease (other than CIU) that would interfere with study evaluations.
- Subjects must understand and be able to adhere to visit schedules, and agree to complete the questionnaires and a diary.
Key exclusion criteria (13 listed)
- Women who are pregnant or nursing.
- Subjects who used any investigational drug in the last 30 days prior to Visit 1
- Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
- Subjects who have been treated with any investigational antibodies for asthma or allergic rhinitis in the 90 days prior to Baseline.
- Subjects who have been treated with intra-muscular or intra-articular corticosteroids in the 90 days prior to Baseline.
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 |
|---|---|---|
| desloratadineAlso: Aerius, SCH 34117Patients received desloratadine 5 mg daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (Placebo) in case of symptoms for 2 months. | Drug | Continuous Treatment |
| desloratadineAlso: Aerius, SCH 34117Patients received Placebo daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (desloratadine 5 mg) in case of symptoms for 2 months. | Drug | PRN regimen |
Primary outcome
Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score.
Time frame: 2 months
9 secondary outcomes
Estimation of disease free period after 3 months of daily treatment.
Time frame: 2 months
Average usage of rescue medication
Time frame: 2 months
Change from Visit 2 in pruritus symptom score assessed by the patient.
Time frame: 2 months
% of patients free of symptoms 2 months after Visit 4
Time frame: 2 months
Changes from Visit 2 of overall conditions of CIU
Time frame: 2 months
Discontinuation due to treatment failure
Time frame: 2 months
Investigator's assessment of response to therapy
Time frame: 2 months
Quality of disease control
Time frame: 2 months
Average consumption of treatment between Visit 2 and Visit 5
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 19133920Grob JJ, Auquier P, Dreyfus I, Ortonne JP. How to prescribe antihistamines for chronic idiopathic urticaria: desloratadine daily vs PRN and quality of life. Allergy. 2009 Apr;64(4):605-12. doi: 10.1111/j.1398-9995.2008.01913.x. Epub 2008 Dec 30.
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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 desloratadine in people with Urticaria and 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 6 inclusion and 13 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 15 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score. (time frame: 2 months). 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 NCT00783354, which also lists 1 linked publication.
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 15 Aug 2024.