Seasonal Allergic RhinitisPhase 4NCT00783146
Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR) (Study P04054)
A Phase 4 study testing desloratadine and fexofenadine in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-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 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- desloratadine and fexofenadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 728 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2004to 1 Oct 2004
- 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 years and older
- 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, including adherence to dosing and visit schedules by signing a written informed consent (the parent/guardian of a subject under 18 years of age also had to sign the informed consent form);
- have been 12 years of age or older, of either sex and any race;
- have had at least a 2-year history (self-reported history was acceptable) of seasonal allergic rhinitis occurring during the same season(s) as the current study;
- have been skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with a wheal diameter at least 7 mm larger than the diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, which could include seasonal molds, prevalent in the geographical area of the study site during the study period;
- if female and of childbearing potential (including women who were less than 1 year postmenopausal and women who became sexually active during the study), have been using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation);
- if female and of childbearing potential, have had a negative urine pregnancy test at Baseline;
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- have been free of any clinically significant disease (other than SAR) that would interfere with study evaluations;
- have understood and been able to adhere to the dosing and visit schedules, and agreed to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary;
- have met the following at the Screening Visit: total symptom score (TSS) of 6 or greater (not including congestion), with 2 or more symptoms rated as moderate (2) or severe (3) and no symptom rated as very severe (4) during the 12 hours prior to this visit;
- have met the following on the morning of the Baseline Visit: symptom severity score 7 AM instantaneous TSS of 6 or more (not including congestion), with 2 or more symptoms rated as moderate (2) or severe (3), and no symptom rated as very severe (4).
Who cannot join
- if female, were pregnant, intended to become pregnant during the study, or were nursing;
- had not observed the designated washout periods for any of the prohibited medications;
- had current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precluded the subject's participation in the study; particular attention was to be given to conditions that would interfere with the absorption, distribution, metabolism or excretion of the study drug, or with the subject's ability to complete the diary cards;
- had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, may have interfered with the study evaluation or affected subject safety;
- were in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study;
- were participating in any other clinical study(ies);
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- were part of the investigational study staff or a family member of the staff personnel directly involved with this study;
- had asthma, with the exception of mild intermittent asthma, ie, controlled with the use of short acting, beta2-agonist adrenoreceptor rescue medication;
- had a current or past history of frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip;
- had rhinitis medicamentosa;
- had a history of intranasal drug abuse;
- had a history of hypersensitivity to the study drugs or their excipients, or to Claritin;
- 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, or had persistent symptoms at the time of the Screening Visit;
- had nasal structural abnormalities, including nasal polyps easily visible on physical examination and marked septum 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;
- if on immunotherapy (desensitization therapy) should not have had a change in dose during the study, and should have remained on the same dose throughout the trial; were not to have received desensitization treatment within 24 hours prior to a visit;
- had been previously randomized into the study at any study site;
- ability to provide informed consent was compromised;
- had a history of non-compliance with medications or treatment protocols;
- had a history of difficulty swallowing pills or had known upper gastrointestinal narrowing or abnormal esophageal peristalsis;
- was a night-shift worker or did not have a standard asleep at night / awake during the day cycle;
- planned to travel outside of the study area during the time of their participation in the study.
About this study
Official title: A Placebo Controlled Study of the Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. in the Treatment of Subjects With Symptomatic Seasonal Allergic Rhinitis (SAR)
This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- desloratadine, fexofenadine, placebo
- 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.
desloratadineDrug
Also called SCH 34117; Clarinex
desloratadine, 5 mg oral tablets, once daily for 15 days
fexofenadineDrug
Also called Allegra
fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated
placeboDrug
placebo, once daily for 15 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | desloratadine Receives: Drug: desloratadine |
| 2 | Active comparator | fexofenadine Receives: Drug: fexofenadine |
| 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 mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment
Measured: 15 days
Secondary outcomes (4)
Change from Baseline in the mean AM/PM self-rated 12-hour reflective TSS (not including nasal congestion) averaged over the 15 days of treatment.
Measured: 15 days
Change from Baseline in the mean AM self-rated instantaneous individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
Measured: 15 days
Change from Baseline in the mean AM/PM self-rated 12-hour reflective individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
Measured: 15 days
Joint physician-patient evaluation of response to therapy.
Measured: Day 8 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study start1 Aug 2004
- Primary completion1 Oct 2004
- Study completion1 Oct 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 728 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
- NCT00783146
- Sponsor's protocol ID
- P04054
- Status last verified
- Feb 2022
- First submitted
- 30 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Berger WE, Lumry WR, Meltzer EO, Pearlman DS. Efficacy of desloratadine, 5 mg, compared with fexofenadine, 180 mg, in patients with symptomatic seasonal allergic rhinitis. Allergy Asthma Proc. 2006 May-Jun;27(3):214-23. doi: 10.2500/aap.2006.27.2851.
PubMed 16913264
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 Placebo Controlled Study of the Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. in the Treatment of Subjects With Symptomatic Seasonal Allergic Rhinitis (SAR)
- ClinicalTrials.gov ID
- NCT00783146
- Acronym / sponsor ID
- P04054
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2004 (actual)
- Primary completion
- 1 Oct 2004 (actual)
- Study completion
- 1 Oct 2004 (actual)
- First posted
- 31 Oct 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 (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-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: fexofenadinefexofenadine |
| 3 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- have demonstrated their willingness to participate in the study and comply with its procedures, including adherence to dosing and visit schedules by signing a written informed consent (the parent/guardian of a subject under 18 years of age also had to sign the informed consent form);
- have been 12 years of age or older, of either sex and any race;
- have had at least a 2-year history (self-reported history was acceptable) of seasonal allergic rhinitis occurring during the same season(s) as the current study;
- have been skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with a wheal diameter at least 7 mm larger than the diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, which could include seasonal molds, prevalent in the geographical area of the study site during the study period;
- if female and of childbearing potential (including women who were less than 1 year postmenopausal and women who became sexually active during the study), have been using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation);
Key exclusion criteria (22 listed)
- if female, were pregnant, intended to become pregnant during the study, or were nursing;
- had not observed the designated washout periods for any of the prohibited medications;
- had current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precluded the subject's participation in the study; particular attention was to be given to conditions that would interfere with the absorption, distribution, metabolism or excretion of the study drug, or with the subject's ability to complete the diary cards;
- had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, may have interfered with the study evaluation or affected subject safety;
- were in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study;
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: SCH 34117; Clarinexdesloratadine, 5 mg oral tablets, once daily for 15 days | Drug | 1 |
| fexofenadineAlso: Allegrafexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated | Drug | 2 |
| placeboplacebo, once daily for 15 days | Drug | 3 |
Primary outcome
Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment
Time frame: 15 days
4 secondary outcomes
Change from Baseline in the mean AM/PM self-rated 12-hour reflective TSS (not including nasal congestion) averaged over the 15 days of treatment.
Time frame: 15 days
Change from Baseline in the mean AM self-rated instantaneous individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
Time frame: 15 days
Change from Baseline in the mean AM/PM self-rated 12-hour reflective individual symptom scores, including nasal congestion, averaged over the 15 days of treatment.
Time frame: 15 days
Joint physician-patient evaluation of response to therapy.
Time frame: Day 8 and Day 15
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.
- Results publication: PubMed 16913264Berger WE, Lumry WR, Meltzer EO, Pearlman DS. Efficacy of desloratadine, 5 mg, compared with fexofenadine, 180 mg, in patients with symptomatic seasonal allergic rhinitis. Allergy Asthma Proc. 2006 May-Jun;27(3):214-23. doi: 10.2500/aap.2006.27.2851.
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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 fexofenadine 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 10 inclusion and 22 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?
Compare the efficacy of the study treatments with respect to the change from Baseline in the mean AM self-rated instantaneous total symptom score (TSS) (not including nasal congestion) averaged over the 15 days of treatment (time frame: 15 days). 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 NCT00783146, 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.