UrticariaPhase 3NCT00795158
How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988)
A Phase 3 study testing desloratadine in people with Urticaria, run by Organon and Co.
Trial summary
The purpose of this study was to determine the effect of desloratadine treatment on quality of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. 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
- 282 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jan 2004
- Phase
- Phase 3
- 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 into 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) must be using an acceptable method of birth control since at least one month prior to visit 1 (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.
- Subjects must be in general good health as confirmed by medical history and, physical examination; i.e., they must be free of any clinically significant disease (other than chronic urticaria [CU]) 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 accurately and consistently in a daily diary symptom severity scores, medication times, concomitant medications, and adverse events.
- Subjects must have a history of CU defined as at least 6 weeks of pruritus and hives with hives lasting less than 24 hours and occurring at least 2 days per week.
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- Subjects must be experiencing a current CU flare with hives present at least 2 days in the week prior to the consent visit/visit 1.
- Subjects must have a pruritus score >=2 and a hive score >=1 at consent visit/Visit 1 or during the 12 hours before the consent visit/Visit 1
- Subjects must score the Overall Condition of CU >=2 at both consent visit/Visit 1 and Visit 2 (Baseline).
- Subjects must have a total pruritus score of >=11 for the sum of morning (AM) and evening (PM) (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
- Subjects with asthma
- Subjects with drug or food allergies that manifest as skin reactions during 1 year prior to consent visit / visit 1
- Subjects with atopic dermatitis
- Subjects with urticaria that is primarily due to physical urticaria or other known etiology (on the basis of clinical history and physical examination).
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- Subjects with CU unresponsive to antihistamines.
- Subjects under regular treatment with NSAIDs.
- Subjects who have been hospitalized because of worsening in their CU within 3 months prior to Visit 1 (Screening).
- Subjects with a history of hypersensitivity to Desloratadine or any of its excipients.
- Subjects previously enrolled into this study (i.e. who have been assigned to treatment).
- Subjects who are staff personnel directly involved with the administration of this study.
- Subjects who have any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, neoplastic, 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.
- Subject treated with any investigational drug in the last 30 days prior to baseline
About this study
Official title: An Open-Label Study of the Effects of Desloratadine Treatment on the Quality of Life of Patients With Chronic Urticaria
The purpose of this study was to determine the effect of desloratadine treatment on quality of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week, patients filled out a questionnaire to tell how their hives affected their lives. This questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a diary every day to tell how much itching they had, how many hives they had, and how their hives had affected their sleep or daily activities. The patients and doctors rated the patients' overall condition and how much relief patients got from treatment.
- 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 Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
desloratadine 5 mg tablets; one tablet orally once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to day 28 in Dermatology Life Quality Index (DLQI) score
Measured: Baseline and treatment day 28
Secondary outcomes (6)
Change from Baseline in the DLQI score on treatment days 7, 14, 21
Measured: Baseline and treatment days 7, 14, 21
Change from Baseline in pruritus, the number of hives, sleep quality, and daily activity impairment on treatment days 7, 14, 21, and 28
Measured: Baseline and treatment days 7, 14, 21, and 28
Change from Baseline in the Overall Condition of chronic urticaria on treatment days 14 and 28
Measured: Baseline and treatment days 14 and 28
Percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief on treatment days 14 and 28
Measured: Treatment days 14 and 28
Evaluation of tolerability and safety by clinical laboratory tests
Measured: Baseline and treatment day 28
Evaluation of tolerability and safety by adverse events
Measured: Screening, Baseline, and treatment days 14 and 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 startNov 2002
- Primary completionJan 2004
- Study completionJan 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 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
- NCT00795158
- Sponsor's protocol ID
- P02988
- Status last verified
- Feb 2022
- First submitted
- 20 Nov 2008
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Seidenari S, Cirillo A, Amoroso S, Flori ML, Amerio P, Ricciuti E, Vena GA, Berardesca E, Le Grazie C and the Italian Study Group on Desloratadine (DL) in Chronic Urticaria. Desloratadine 5 milligrams once daily improves quality of life in chronic idiopathic urticaria. G Ital Dermatol Venereol. 2006;141(3):207-214
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 Treatment on the Quality of Life of Patients With Chronic Urticaria
- ClinicalTrials.gov ID
- NCT00795158
- Acronym / sponsor ID
- P02988
- Conditions
- Urticaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (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.
The purpose of this study was to determine the effect of desloratadine treatment on quality of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week, patients filled out a questionnaire to tell how their hives affected their lives. This questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a diary every day to tell how much itching they had, how many hives they had, and how their hives had affected their sleep or daily activities. The patients and doctors rated the patients' overall condition and how much relief patients got from treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | 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 (11 listed)
- Subjects must demonstrate their willingness to participate into 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) must be using an acceptable method of birth control since at least one month prior to visit 1 (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.
- Subjects must be in general good health as confirmed by medical history and, physical examination; i.e., they must be free of any clinically significant disease (other than chronic urticaria [CU]) 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 accurately and consistently in a daily diary symptom severity scores, medication times, concomitant medications, and adverse events.
Key exclusion criteria (16 listed)
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications
- Subjects with asthma
- Subjects with drug or food allergies that manifest as skin reactions during 1 year prior to consent visit / visit 1
- Subjects with atopic dermatitis
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: Clarinex; Aerius; SCH 34117; descarboethoxyloratadinedesloratadine 5 mg tablets; one tablet orally once a day for 28 days | Drug | Arm 1 |
Primary outcome
Change from baseline to day 28 in Dermatology Life Quality Index (DLQI) score
Time frame: Baseline and treatment day 28
6 secondary outcomes
Change from Baseline in the DLQI score on treatment days 7, 14, 21
Time frame: Baseline and treatment days 7, 14, 21
Change from Baseline in pruritus, the number of hives, sleep quality, and daily activity impairment on treatment days 7, 14, 21, and 28
Time frame: Baseline and treatment days 7, 14, 21, and 28
Change from Baseline in the Overall Condition of chronic urticaria on treatment days 14 and 28
Time frame: Baseline and treatment days 14 and 28
Percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief on treatment days 14 and 28
Time frame: Treatment days 14 and 28
Evaluation of tolerability and safety by clinical laboratory tests
Time frame: Baseline and treatment day 28
Evaluation of tolerability and safety by adverse events
Time frame: Screening, Baseline, and treatment days 14 and 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.
- Results publicationSeidenari S, Cirillo A, Amoroso S, Flori ML, Amerio P, Ricciuti E, Vena GA, Berardesca E, Le Grazie C and the Italian Study Group on Desloratadine (DL) in Chronic Urticaria. Desloratadine 5 milligrams once daily improves quality of life in chronic idiopathic urticaria. G Ital Dermatol Venereol. 2006;141(3):207-214
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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 3 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 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 to day 28 in Dermatology Life Quality Index (DLQI) score (time frame: Baseline and treatment day 28). 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 NCT00795158, 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 17 Feb 2022.