UrticariaPhase 4NCT00795522
An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria (Study P02540)
A Phase 4 study testing Desloratadine in people with Urticaria, run by Organon and Co.
Trial summary
This open-label study is being conducted to determine the effect of DL treatment for CIU on symptom and disease severity, quality of life, daytime functioning, and quality of sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Mar 2005
- 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, of either sex and any race.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
- Subjects must be in general good health; i.e., 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 the dosing and visit schedules, and agree to complete the questionnaires and to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
- Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1 (Screening).
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- Subjects must have a pruritus score >= 2 and a hive score >= 1 at Visit 1.
- Subjects must be experiencing a current CIU flare of at least 3 weeks duration, with hives present at least 3 days per week, prior to Visit 1 (Screening).
- Subjects must score the overall condition of CIU >= 2 at both Visit 1 (Screening) and Visit 2 (Baseline).
- Subjects must have a total pruritus score of >= 14 for the sum of morning and evening (reflective) diary scores for the 3 days prior to Visit 2 (Baseline) plus the morning score on the day of Visit 2.
- Women of childbearing potential must have a negative urine pregnancy test at Visit 2 (Baseline).
Who cannot join
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications outlined.
- Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
- Subjects with drug or food allergies that manifest as skin reactions.
- Subjects with urticaria that is primarily due to physical urticaria or other known etiology.
- Subjects with CIU unresponsive to antihistamines.
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- Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit 1 (Screening).
- Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
- Subjects previously randomized into this study.
- Subjects who are staff personnel directly involved with the administration of this study.
- Subjects who have any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, 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: An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria
This open-label study is being conducted to determine the effect of DL treatment for CIU on symptom and disease severity, quality of life, daytime functioning, and quality of sleep.
- Conditions
- Urticaria
- Being tested
- Desloratadine
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Also called SCH 034117
Subjects will receive DL 5 mg daily for 28 days. Each active DL tablet contains 5 mg of desloratadine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Desloratadine Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Short Form 12 (SF-12) Health Survey Questionnaire, mental, physical and total scores on treatment days 7, 14, 21, and 28.
Measured: treatment days 7, 14, 21, and 28
Secondary outcomes (3)
Change from Baseline in work/school attendance and self-assessed productivity as measured by the WPAI questionnaire
Measured: treatment days 7, 14, 21, and 28
Change from Baseline in pruritus, the number of hives and the maximum size of hives, sleep quality, and activity impairment
Measured: treatment weeks 1, 2, 3, and 4
The percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startJul 2003
- Primary completionFeb 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 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
- NCT00795522
- Sponsor's protocol ID
- P02540
- Status last verified
- Feb 2022
- First submitted
- 19 Nov 2008
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria
- ClinicalTrials.gov ID
- NCT00795522
- Acronym / sponsor ID
- P02540
- Conditions
- Urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 21 Nov 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 open-label study is being conducted to determine the effect of DL treatment for CIU on symptom and disease severity, quality of life, daytime functioning, and quality of sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: DesloratadineDesloratadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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, of either sex and any race.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
- Subjects must be in general good health; i.e., 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 the dosing and visit schedules, and agree to complete the questionnaires and to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
Key exclusion criteria (13 listed)
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications outlined.
- Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
- Subjects with drug or food allergies that manifest as skin reactions.
- Subjects with urticaria that is primarily due to physical urticaria or other known etiology.
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: SCH 034117Subjects will receive DL 5 mg daily for 28 days. Each active DL tablet contains 5 mg of desloratadine | Drug | Arm 1 |
Primary outcome
Change from Baseline in the Short Form 12 (SF-12) Health Survey Questionnaire, mental, physical and total scores on treatment days 7, 14, 21, and 28.
Time frame: treatment days 7, 14, 21, and 28
3 secondary outcomes
Change from Baseline in work/school attendance and self-assessed productivity as measured by the WPAI questionnaire
Time frame: treatment days 7, 14, 21, and 28
Change from Baseline in pruritus, the number of hives and the maximum size of hives, sleep quality, and activity impairment
Time frame: treatment weeks 1, 2, 3, and 4
The percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief
Time frame: day 28
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 17 Feb 2022.
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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, 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 11 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 17 Feb 2022. 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?
Change from Baseline in the Short Form 12 (SF-12) Health Survey Questionnaire, mental, physical and total scores on treatment days 7, 14, 21, and 28. (time frame: treatment days 7, 14, 21, and 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.