Seasonal Allergic RhinitisPhase 3NCT02320396
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
A Phase 3 study testing Desloratadine 5 mg in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Desloratadine 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 449 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2015to 27 Apr 2015
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
- Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.
Who cannot join
- Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
- Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
- Has asthma that is under treatment and/or uncontrolled
- Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
- Has vasomotor rhinitis or eosinophilic rhinitis
- Has a history of hypersensitivity to antihistamines or ingredients of study drug
Show all 16Show fewer
- Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs [injectable]) or immunological drugs within 28 days prior to Visit 2
- Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
- Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
- Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
- Will receive nasal nebulizer therapy and/or thermotherapy during study period
- Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
- Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
- Has a history of severe drug allergy (e.g. anaphylactoid reaction)
- Is pregnant or lactating or may be pregnant
- Is planning a remote trip for more than 1 day during the Symptom Confirmation Period or for more than 2 days during the Treatment Period.
About this study
Official title: A Phase III, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Seasonal Allergic Rhinitis
This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.
Read the detailed description
This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Desloratadine 5 mg, 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.
Desloratadine 5 mgDrug
Desloratadine 5 mg tablets
PlaceboDrug
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine | Experimental | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period. Receives: Drug: Desloratadine 5 mg |
| Placebo | Placebo comparator | After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
Number of Participants Who Experience at Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
Measured: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
Number of Participants Who Discontinue Study Drug Due to an AE
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
Measured: Up to 2 weeks
Secondary outcomes (10)
Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy
Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 8 to 13 (Week 2) of double-blind treatment
Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy
Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy
Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.
Measured: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2
The investigator assessed the participant's symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant's symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant's case report form. The investigator's impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant's own impression at Week 2. The percentage of participants with assessments of "Better" and "Much better" graded by the investigator (Investigator's Impression Rate) was reported and analyzed using Odds Ratio analysis.
Measured: From Baseline to Week 2
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2
The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of "Better" and "Much better" graded by the participant (Participant's Impression Rate) was reported and analyzed using Odds Ratio analysis.
Measured: From Baseline to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start9 Jan 2015
- Primary completion27 Apr 2015
- Study completion27 Apr 2015
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320396
- Sponsor's protocol ID
- 4117-204
- Other IDs
- 152861, MK-4117-204
- Status last verified
- Feb 2022
- First submitted
- 15 Dec 2014
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Okubo K, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with seasonal allergic rhinitis: A randomized controlled trial. Arerugi. 2016;32(11):863-876.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02320396
- Acronym / sponsor ID
- 4117-204
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2015 (actual)
- Primary completion
- 27 Apr 2015 (actual)
- Study completion
- 27 Apr 2015 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.
Detailed description
This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desloratadine | Experimental | Drug: Desloratadine 5 mgAfter a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period. |
| Placebo | Placebo comparator | Drug: PlaceboAfter a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
- Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.
Key exclusion criteria (16 listed)
- Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
- Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
- Has asthma that is under treatment and/or uncontrolled
- Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
- Has vasomotor rhinitis or eosinophilic rhinitis
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 mgDesloratadine 5 mg tablets | Drug | Desloratadine |
| PlaceboPlacebo tablets | Drug | Placebo |
Primary outcome
Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy
Time frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or "none"] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or "none"] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.
Number of Participants Who Experience at Least One Adverse Event (AE)
Time frame: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
Number of Participants Who Discontinue Study Drug Due to an AE
Time frame: Up to 2 weeks
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
10 secondary outcomes
Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment
Time frame: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
Time frame: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)
Time frame: Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy
Time frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
Time frame: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment
Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)
Time frame: Baseline, Day 8 to 13 (Week 2) of double-blind treatment
Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy
Time frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)
Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy
Time frame: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2
Time frame: From Baseline to Week 2
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2
Time frame: From Baseline to Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationOkubo K, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with seasonal allergic rhinitis: A randomized controlled trial. Arerugi. 2016;32(11):863-876.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desloratadine 5 mg 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 2 inclusion and 16 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 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 30 May 2016). 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?
Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy (time frame: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment). The study lists 3 primary outcomes in all. 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 NCT02320396, 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 17 May 2024.