Seasonal Allergic RhinitisPhase 4NCT00867191
Comparison of the Effects of Desloratadine and Placebo in the Relief of Nasal Symptom Scores in Subjects With Seasonal Allergic Rhinitis to Cypress Pollen (Study P02836)
A Phase 4 study testing Desloratadine in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
The purpose of this study was to demonstrate the efficacy (% of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2002to 1 Apr 2003
- 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
- Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Patients must be >=18 years of age, of either gender.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g. hormonal contraceptive, medically prescribed intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g. hysterectomy or tubal ligation). Women of childbearing potential 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.
- Patients must be in good general health; i.e., they must be free of any clinically significant disease (other than SAR to cypress pollen) that could interfere with study evaluations.
- Patients must understand and be able to adhere to the measurement, dosing and visit schedules, and agree to report concomitant medications and adverse events to the investigator or designee.
- Patients must have at least a two-year history (self-reported being acceptable) of intermittent allergic rhinitis specifically from January to March
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- Patients must be clinically symptomatic with SAR to cypress pollen at Visit 2 (Day 0): the total (nasal + non-nasal) symptom score must be >=8 with a nasal congestion score >=2. Patients may be rescheduled up to two additional times for the qualifying visit if they do not meet the minimum symptom scores
- A positive skin prick test and / or positive cypress-specific IgE by RAST (>= class 2). These tests should have been performed within 24 months before Visit 1
- Women of childbearing potential must have a negative urine pregnancy test at Visit 2 (Day 0).
Who cannot join
- Women who are pregnant or nursing.
- Patients who have not observed the designated washout periods for any of the prohibited medications.
- Patients with rhinitis medicamentosa.
- Patients who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (screening / consent) or patients who have had a viral upper respiratory infection within 7 days prior to Visit 2.
- Patients who have nasal structural abnormalities, including nasal polyps and marked septal deviation, interfering significantly with nasal airflow.
- Patients with a history of hypersensitivity to desloratadine or any of its excipients.
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- Patients who are staff personnel directly involved with the administration of this study.
- Patients previously randomised in this study.
- Patients having used any investigational drug in the last 30 days prior to Visit 1.
- Patients who have any current evidence of clinically significant haematopoietic, metabolic, cardiovascular, immunological, neurological, haematological, gastrointestinal, hepatic, renal, psychiatric, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect patient safety.
About this study
Official title: A Multi-Centre, Double-Blind, Randomised Comparison Of The Effects Of Desloratadine (Aerius®) And Placebo In The Relief Of Nasal Symptom Scores In Subjects With Seasonal Allergic Rhinitis (Sar) To Cypress Pollen
The purpose of this study was to demonstrate the efficacy (% of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Placebo, Desloratadine
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo, 1 tablet daily, per os., 15 days
DesloratadineDrug
Also called SCH 34117
Desloratadine, one 5 mg tablet daily, per os, 15 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo, 1 tablet daily, per os Receives: Drug: Placebo |
| 2 | Active comparator | Desloratadine, one 5 mg tablet daily, per os Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective was to demonstrate the efficacy (as percentage of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.
Measured: After 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study start1 Feb 2002
- Primary completion1 Apr 2003
- Study completion1 Apr 2003
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 Seasonal Allergic RhinitisStudies 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, Care provider
- Enrolment
- 233 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
- NCT00867191
- Sponsor's protocol ID
- P02836
- Status last verified
- Feb 2022
- First submitted
- 20 Mar 2009
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Demoly P, Dreyfus I, Dhivert-Donnadieu H, Mesbah K. Desloratadine for the treatment of cypress pollen-induced allergic rhinitis. Ann Allergy Asthma Immunol. 2009 Sep;103(3):260-6. doi: 10.1016/S1081-1206(10)60191-3.
PubMed 19788025
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 Multi-Centre, Double-Blind, Randomised Comparison Of The Effects Of Desloratadine (Aerius®) And Placebo In The Relief Of Nasal Symptom Scores In Subjects With Seasonal Allergic Rhinitis (Sar) To Cypress Pollen
- ClinicalTrials.gov ID
- NCT00867191
- Acronym / sponsor ID
- P02836
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2002 (actual)
- Primary completion
- 1 Apr 2003 (actual)
- Study completion
- 1 Apr 2003 (actual)
- First posted
- 23 Mar 2009 (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 demonstrate the efficacy (% of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo, 1 tablet daily, per os |
| 2 | Active comparator | Drug: DesloratadineDesloratadine, one 5 mg tablet daily, per os |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Patients must be >=18 years of age, of either gender.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control (e.g. hormonal contraceptive, medically prescribed intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g. hysterectomy or tubal ligation). Women of childbearing potential 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.
- Patients must be in good general health; i.e., they must be free of any clinically significant disease (other than SAR to cypress pollen) that could interfere with study evaluations.
- Patients must understand and be able to adhere to the measurement, dosing and visit schedules, and agree to report concomitant medications and adverse events to the investigator or designee.
Key exclusion criteria (10 listed)
- Women who are pregnant or nursing.
- Patients who have not observed the designated washout periods for any of the prohibited medications.
- Patients with rhinitis medicamentosa.
- Patients who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (screening / consent) or patients who have had a viral upper respiratory infection within 7 days prior to Visit 2.
- Patients who have nasal structural abnormalities, including nasal polyps and marked septal deviation, interfering significantly with nasal airflow.
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 |
|---|---|---|
| PlaceboPlacebo, 1 tablet daily, per os., 15 days | Drug | 1 |
| DesloratadineAlso: SCH 34117Desloratadine, one 5 mg tablet daily, per os, 15 days | Drug | 2 |
Primary outcome
The primary objective was to demonstrate the efficacy (as percentage of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen.
Time frame: After 14 days of treatment
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.
- Derived from this study: PubMed 19788025Demoly P, Dreyfus I, Dhivert-Donnadieu H, Mesbah K. Desloratadine for the treatment of cypress pollen-induced allergic rhinitis. Ann Allergy Asthma Immunol. 2009 Sep;103(3):260-6. doi: 10.1016/S1081-1206(10)60191-3.
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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 Seasonal Allergic Rhinitis, 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 9 inclusion and 10 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. 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 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?
The primary objective was to demonstrate the efficacy (as percentage of change from baseline) of desloratadine to improve the nasal total symptom score of SAR to cypress pollen. (time frame: After 14 days of treatment). 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 NCT00867191, 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.