Seasonal Allergic RhinitisPhase 4NCT00794495
Preference for Clarinex Tablets vs. Zyrtec Tablets in Patients With Allergies (P03181)
A Phase 4 study testing Desloratadine 5 mg (Clarinex) and Cetirizine (Zyrtec) in people with Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis, run by Organon and Co.
Trial summary
This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis
- What is being tested?
- Desloratadine 5 mg (Clarinex) and Cetirizine (Zyrtec)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Jul 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
- had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
- currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
- had not taken Zyrtec® or Clarinex® within the previous year;
- were 18 years of age or older;
- had negative urine test (hCG) for females of childbearing potential;
- for women of childbearing potential, agreed to use a medically accepted method of birth control;
- were free of any clinically significant disease (other than AR) that would interfere with study evaluations.
Who cannot join
- were pregnant or nursing;
- had allergic or idiosyncratic reaction to antihistamines;
- had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
- had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
- in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
- had an upper respiratory tract or sinus infection that required antibiotic therapy with the last dose within 14 days prior to Screening, or had a viral upper respiratory infection within 7 days prior to Screening;
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- had asthma, unless their symptoms could be controlled by a short-acting inhaled Beta2-agonist used on an "as needed" basis;
- were on immunotherapy, unless they were on a stable maintenance schedule prior to screening. The dose of immunotherapy should remain constant and subjects could not receive immunotherapy within 24 hours prior to any visit;
- had a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that were likely to limit the validity of consent to participate in the study;
- had a history of non-compliance with medications or treatment protocols;
- had any clinically significant deviation from normal in the physical examination that, in the Investigator's judgment, may have interfered with the study evaluations or affect subject safety;
- had any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the Investigator, might interfere with the study evaluations or affect subject safety;
- had liver or renal impairment.
About this study
Official title: Preference Evaluation of Clarinex Tablets vs. Zyrtec Tablets in Subjects With Symptomatic Allergic Rhinitis
This was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.
- Being tested
- Desloratadine 5 mg (Clarinex), Cetirizine (Zyrtec)
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine 5 mg (Clarinex)Drug
Also called Clarinex, SCH 34117
Clarinex 5 mg daily x 7 days
Cetirizine (Zyrtec)Drug
Also called Zyrtec®
Zyrtec 10 mg daily x 7 days
| Study group | Role | What they receive |
|---|---|---|
| Clarinex followed by Zyrtec | Experimental | Clarinex 5 mg by mouth daily for 7 days followed by Zyrtec 10 mg by mouth daily for 7 days, with 5-28 days washout between treatments. Receives: Drug: Desloratadine 5 mg (Clarinex); Drug: Cetirizine (Zyrtec) |
| Zyrtec followed by Clarinex | Experimental | Zyrtec 10 mg by mouth daily for 7 days followed by Clarinex 5 mg by mouth daily for 7 days, with 5-28 days washout between treatments. Receives: Drug: Desloratadine 5 mg (Clarinex); Drug: Cetirizine (Zyrtec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy measure was the preference rates calculated from subject comparative evaluation.
Measured: 1 day after the last treatment period (Visit 5)
Secondary outcomes (1)
Subject Non-Comparative Evaluation and subject Response to Therapy
Measured: 1 day after the end of each 7-day treatment period (Visit 3 and Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startDec 2002
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 122 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
- NCT00794495
- Sponsor's protocol ID
- P03181
- 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
- Preference Evaluation of Clarinex Tablets vs. Zyrtec Tablets in Subjects With Symptomatic Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00794495
- Acronym / sponsor ID
- P03181
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 20 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 was a crossover study designed to see if patients with allergy symptoms preferred Clarinex® or Zyrtec®. Patients were randomized to take 7 days of Clarinex or Zyrtec treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Zyrtec, the patient prefers more.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarinex followed by Zyrtec | Experimental | Drug: Desloratadine 5 mg (Clarinex), Drug: Cetirizine (Zyrtec)Clarinex 5 mg by mouth daily for 7 days followed by Zyrtec 10 mg by mouth daily for 7 days, with 5-28 days washout between treatments. |
| Zyrtec followed by Clarinex | Experimental | Drug: Desloratadine 5 mg (Clarinex), Drug: Cetirizine (Zyrtec)Zyrtec 10 mg by mouth daily for 7 days followed by Clarinex 5 mg by mouth daily for 7 days, with 5-28 days washout between treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- had at least a two-year history of seasonal allergic rhinitis and/or perennial allergic rhinitis;
- currently experiencing symptoms of AR, including nasal symptoms at Visits 2 and 4, prior to entering each treatment phase;
- had not taken Zyrtec® or Clarinex® within the previous year;
- were 18 years of age or older;
- had negative urine test (hCG) for females of childbearing potential;
Key exclusion criteria (13 listed)
- were pregnant or nursing;
- had allergic or idiosyncratic reaction to antihistamines;
- had current or history of frequent, clinically significant sinusitis or chronic purulent nasal discharge;
- had rhinitis medicamentosa or nasal structural abnormalities (including large nasal polyps and marked septal deviation) that significantly interfered with nasal airflow;
- in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids (ie, subjects who could or would not observe the washout period for these prohibited medications);
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 |
|---|---|---|
| Desloratadine 5 mg (Clarinex)Also: Clarinex, SCH 34117Clarinex 5 mg daily x 7 days | Drug | Clarinex followed by Zyrtec, Zyrtec followed by Clarinex |
| Cetirizine (Zyrtec)Also: Zyrtec®Zyrtec 10 mg daily x 7 days | Drug | Clarinex followed by Zyrtec, Zyrtec followed by Clarinex |
Primary outcome
The primary efficacy measure was the preference rates calculated from subject comparative evaluation.
Time frame: 1 day after the last treatment period (Visit 5)
1 secondary outcome
Subject Non-Comparative Evaluation and subject Response to Therapy
Time frame: 1 day after the end of each 7-day treatment period (Visit 3 and Visit 5)
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 5 mg (Clarinex) and Cetirizine (Zyrtec) in people with Seasonal Allergic Rhinitis and Perennial 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 7 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?
The primary efficacy measure was the preference rates calculated from subject comparative evaluation. (time frame: 1 day after the last treatment period (Visit 5)). 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.