UrticariaPhase 4NCT00751166
A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)
A Phase 4 study testing Desloratadine and Cetirizine in people with Urticaria, run by Organon and Co.
Trial summary
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Urticaria
- What is being tested?
- Desloratadine and Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2004to 1 May 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent. For pediatric patients, the parent or legal guardian was to have signed a written informed consent.
- Be between 12 and 70 years of age, of either sex and any race.
- Have had signs and symptoms of CIU for at least 6 weeks prior to the Screening Visit.
- Have been experiencing a current flare of their CIU of at least 3 weeks prior to the Baseline Visit. Hives were to have been present for at least 3 days per week during the current flare prior to the Baseline Visit.
- Have an overall condition of CIU that was at least of "moderate" severity (minimum score of 2) at both Screening and Baseline Visits.
- Have at least a moderately severe pruritus score (minimum score of 2) and hives (minimum score of 1) present at Screening.
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- Have, at Baseline, a total pruritus score of 14 or greater for the sum of AM and PM (reflective) diary scores for the 3 days prior to Baseline and the AM diary score on Day 1.
- Understand and be able to adhere to the dosing and visit schedules, and agree to assess and record their symptom severity scores, medication times,concomitant medications, and adverse events accurately and consistently in a daily diary.
- Be in general good health and free of any clinically significant disease (other than CIU) that would have interfered with study evaluations.
- If female and of childbearing potential, have had a negative urine (hCG) pregnancy test at the time of Baseline (Visit 2).
- Female subjects of childbearing potential were to be counseled in the appropriate use of birth control while in the study. They were to be using a medically accepted method of birth control, for example: double barrier method, oral contraceptive, Depo-Provera®, or Norplant®, prior to Baseline and during the study. Women who were not sexually active were to agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study. If the subject had had a tubal ligation or was using an intra-uterine device, or if the husband/partner had had a vasectomy, another method was to be used.
Who cannot join
- Had asthma requiring chronic use of inhaled or systemic corticosteroids.
- Had been unresponsive to antihistamine treatment in the past.
- Had a history of allergies to more than two classes of medication or who were allergic to or unable to tolerate antihistamines.
- Had used any investigational drug in the last 30 days prior to Baseline.
- Had food or drug allergies manifested as skin reactions. Subjects with urticaria that was primarily due to physical urticaria or other known etiology.
- If female, were pregnant or nursing.
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- Had a history of hypersensitivity to the study drug or its excipients.
- Were family members of the investigational study staff involved with this study.
- Had previously been randomized into the study.
- Had current evidence of clinically significant hematopoietic, cardi distribution, metabolism, or excretion of the study medication or with the subject's ability to reliably complete the diary card.
- Were morbidly obese (BMI >= 35, as described in Appendix 6 of the protocol)
- Had a compromised ability to provide informed consent.
- Had a history of non-compliance with medications or treatment protocols.
About this study
Official title: A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (CIU)
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
- Conditions
- Urticaria
- Being tested
- Desloratadine, Cetirizine, placebo
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days
CetirizineDrug
Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
placeboDrug
placebo once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Desloratadine Receives: Drug: Desloratadine |
| 2 | Active comparator | Cetirizine Receives: Drug: Cetirizine |
| 3 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the efficacy of the study treatments with respect to the change from Baseline in the average AM/PM 12-hour reflective pruritus severity score (diary recordings)
Measured: After the first 7 days of treatment
Secondary outcomes (4)
Joint physician-patient evaluations ("now") of: overall condition of the CIU and overall global therapeutic response.
Measured: At treatment days 14 and 28 (Visit 3 and 4)
Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: severity of pruritus; number of hives; size of largest hives; total symptom score (pruritus, number of hives, size of the largest hives)
Measured: Days 7, 14, 21 and 28
Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: subject-evaluated CIU interference with sleep (AM) and interference with daily activities (PM)
Measured: Days 7, 14, 21 and 28
Adverse Events
Measured: End of Trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study start1 Mar 2004
- Primary completion1 May 2005
- Study completion1 May 2005
Why it stopped: Study could not be re-supplied with study medication in a timely manner.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 149 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
- NCT00751166
- Sponsor's protocol ID
- P03736
- Status last verified
- Feb 2022
- First submitted
- 10 Sep 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
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 Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (CIU)
- ClinicalTrials.gov ID
- NCT00751166
- Acronym / sponsor ID
- P03736
- Conditions
- Urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study could not be re-supplied with study medication in a timely manner.
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 1 May 2005 (actual)
- Study completion
- 1 May 2005 (actual)
- First posted
- 11 Sep 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 was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DesloratadineDesloratadine |
| 2 | Active comparator | Drug: CetirizineCetirizine |
| 3 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Have demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent. For pediatric patients, the parent or legal guardian was to have signed a written informed consent.
- Be between 12 and 70 years of age, of either sex and any race.
- Have had signs and symptoms of CIU for at least 6 weeks prior to the Screening Visit.
- Have been experiencing a current flare of their CIU of at least 3 weeks prior to the Baseline Visit. Hives were to have been present for at least 3 days per week during the current flare prior to the Baseline Visit.
- Have an overall condition of CIU that was at least of "moderate" severity (minimum score of 2) at both Screening and Baseline Visits.
Key exclusion criteria (13 listed)
- Had asthma requiring chronic use of inhaled or systemic corticosteroids.
- Had been unresponsive to antihistamine treatment in the past.
- Had a history of allergies to more than two classes of medication or who were allergic to or unable to tolerate antihistamines.
- Had used any investigational drug in the last 30 days prior to Baseline.
- Had food or drug allergies manifested as skin reactions. Subjects with urticaria that was 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 |
|---|---|---|
| DesloratadineDesloratadine 5 mg, oral tablet, once daily in the morning, 28 days | Drug | 1 |
| CetirizineCetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days | Drug | 2 |
| placeboplacebo once daily for 28 days | Drug | 3 |
Primary outcome
Compare the efficacy of the study treatments with respect to the change from Baseline in the average AM/PM 12-hour reflective pruritus severity score (diary recordings)
Time frame: After the first 7 days of treatment
4 secondary outcomes
Joint physician-patient evaluations ("now") of: overall condition of the CIU and overall global therapeutic response.
Time frame: At treatment days 14 and 28 (Visit 3 and 4)
Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: severity of pruritus; number of hives; size of largest hives; total symptom score (pruritus, number of hives, size of the largest hives)
Time frame: Days 7, 14, 21 and 28
Average AM/PM "reflective" diary scores over treatment days 1-7, 8-14, 15-21 and 22-28 for: subject-evaluated CIU interference with sleep (AM) and interference with daily activities (PM)
Time frame: Days 7, 14, 21 and 28
Adverse Events
Time frame: End of Trial
Results and safety
The study was stopped early (reason given: Study could not be re-supplied with study medication in a timely manner.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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 and Cetirizine 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: stopped early, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study could not be re-supplied with study medication in a timely manner.). Results are not available in the source record.
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?
Compare the efficacy of the study treatments with respect to the change from Baseline in the average AM/PM 12-hour reflective pruritus severity score (diary recordings) (time frame: After the first 7 days of treatment). 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 15 Aug 2024.