HypersensitivityPhase 4NCT00359138
The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)
A Phase 4 study testing desloratadine and levocetirizine in people with Hypersensitivity, run by Organon and Co.
Trial summary
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- desloratadine and levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to May 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18 years of age or older, of either sex.
- Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander.
- Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must understand and be able to adhere to visit schedules
- Subjects must be in general good health.
- Women of child-bearing potential must have a negative pregnancy test at Day -1 and must use an accepted method of contraception during the entire duration of the study.
Who cannot join
- Subjects who have persistent asthma.
- Subjects who have chronic urticaria or atopic dermatosis.
- Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below.
- Medications Prohibited During the Trial and Washout Period Prior to Visit 1
- Corticosteroids
- Intramuscular or intra-articular, 1 month
Show all 33Show fewer
- Oral, inhaled, intravenous, rectal, intranasal, or ocular, 7 days
- High-potency dermatological, 7 days
- Cromolyn/Lodoxamide/Nedocromil
- Intranasal, ocular, inhaled, or oral, 2 days
- Antihistamines
- Long-acting prescription (eg, levocetirizine, fexofenadine, and desloratadine), 15 days
- Short-acting (eg, chlorpheniramine, brompheniramine including over-the-counter [OTC] forms, hydroxyzine), 15 days
- Ocular (eg, levocabastine), 15 days
- Leukotriene inhibitors (eg, montelukast), 7 days
- Systemic antibiotics, 14 days (the washout refers to antibiotics used to treat an upper or lower respiratory tract infection)
- Immunotherapy (desensitization), 1 year
- Decongestants
- oral, 2 days
- local, 2 days
- Ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs; eg, Toradol), 5 days
- Investigational medications, 30 days
- Tricyclic antidepressants (eg, amitriptyline, clomipramine, doxepin, imipramine, trimipramine, amoxapine, desipramine, nortriptyline, protriptyline), 30 days
- Tetracyclic antidepressants (eg, maprotiline, mirtazapine), 30 days
- Subjects with a history of hypersensitivity to desloratadine, to levocetirizine, or any of their excipients.
- Women who are breast-feeding, pregnant, or intend to become pregnant.
- Subjects with any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
- Subjects who have used any investigational drugs within 30 days of randomization.
- Subjects working between 11 PM and 8 AM (night shift).
- Subjects who have skin/color pigmentation incompatible with accurate measurements of flare reaction.
- Subjects with cutaneous hyperactivity: negative prick test control >3 mm.
- Subjects who are participating in any other clinical study.
- Subjects who are part of the staff personnel directly involved with this study.
About this study
Official title: A Double-blind, Double-dummy, Parallel-group, Placebo-controlled, Randomized Study to Assess the Duration of the Suppressive Effects of Desloratadine on the Cutaneous Allergen-induced Wheal and Flare (1) Response After Discontinuation
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.
- Conditions
- Hypersensitivity
- Being tested
- desloratadine, levocetirizine, Desloratadine placebo tablet, Levocetirizine placebo capsule
- Keywords
- Histamine H1 Antagonists, Anti-Allergic Agents
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desloratadineDrug
5 mg tablet once daily
levocetirizineDrug
5 mg capsule once daily
Desloratadine placebo tabletDrug
once daily
Levocetirizine placebo capsuleDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine 5 mg tablet + Levocetirizine placebo capsule | Experimental | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Receives: Drug: desloratadine; Drug: Levocetirizine placebo capsule |
| Desloratadine placebo tablet + Levocetirizine 5 mg capsule | Active comparator | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Receives: Drug: levocetirizine; Drug: Desloratadine placebo tablet |
| Desloratadine placebo tablet + Levocetirizine placebo capsule | Placebo comparator | Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Receives: Drug: Desloratadine placebo tablet; Drug: Levocetirizine placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
The number of days after treatment discontinuation until a measurable wheal and flare response.
Measured: Starting at Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2006
- Study completionMay 2006
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 HypersensitivityStudies 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
- 36 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
- NCT00359138
- Sponsor's protocol ID
- P04441
- Status last verified
- Feb 2022
- First submitted
- 31 Jul 2006
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Double-dummy, Parallel-group, Placebo-controlled, Randomized Study to Assess the Duration of the Suppressive Effects of Desloratadine on the Cutaneous Allergen-induced Wheal and Flare (1) Response After Discontinuation
- ClinicalTrials.gov ID
- NCT00359138
- Acronym / sponsor ID
- P04441
- Conditions
- Hypersensitivity
- Keywords
- Histamine H1 Antagonists, Anti-Allergic Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Posted 1 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.
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 |
|---|---|---|
| Desloratadine 5 mg tablet + Levocetirizine placebo capsule | Experimental | Drug: desloratadine, Drug: Levocetirizine placebo capsuleSubject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| Desloratadine placebo tablet + Levocetirizine 5 mg capsule | Active comparator | Drug: levocetirizine, Drug: Desloratadine placebo tabletSubject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
| Desloratadine placebo tablet + Levocetirizine placebo capsule | Placebo comparator | Drug: Desloratadine placebo tablet, Drug: Levocetirizine placebo capsuleSubject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be 18 years of age or older, of either sex.
- Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander.
- Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must understand and be able to adhere to visit schedules
Key exclusion criteria (33 listed)
- Subjects who have persistent asthma.
- Subjects who have chronic urticaria or atopic dermatosis.
- Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below.
- Medications Prohibited During the Trial and Washout Period Prior to Visit 1
- Corticosteroids
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 |
|---|---|---|
| desloratadine5 mg tablet once daily | Drug | Desloratadine 5 mg tablet + Levocetirizine placebo capsule |
| levocetirizine5 mg capsule once daily | Drug | Desloratadine placebo tablet + Levocetirizine 5 mg capsule |
| Desloratadine placebo tabletonce daily | Drug | Desloratadine placebo tablet + Levocetirizine 5 mg capsule, Desloratadine placebo tablet + Levocetirizine placebo capsule |
| Levocetirizine placebo capsuleonce daily | Drug | Desloratadine 5 mg tablet + Levocetirizine placebo capsule, Desloratadine placebo tablet + Levocetirizine placebo capsule |
Primary outcome
Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
Time frame: Starting at Day 8
The number of days after treatment discontinuation until a measurable wheal and flare response.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 levocetirizine in people with Hypersensitivity, 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 7 inclusion and 33 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 9 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. 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?
Yes. Results are posted in the registry (first posted 1 Nov 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?
Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment (time frame: Starting at Day 8). 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 9 Feb 2022.