Trial Outcomes & Findings for Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204) (NCT NCT02320396)

NCT ID: NCT02320396

Last Updated: 2024-05-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 449 participants
• Primary outcome timeframe: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
• Results posted on: 2024-05-17

Participant Flow

Participants with seasonal allergic rhinitis (SAR) were recruited at 3 study sites in Japan.

Of 1148 participants screened, 449 were enrolled in the study and randomized to oral (PO) once daily (QD) Desloratadine (n=224) or Placebo (n=225). One participant randomized to Desloratadine was not treated due to withdrawn consent.

Participant milestones

Measure	Desloratadine 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo 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.
Overall Study STARTED	224	225
Overall Study Treated (Full Analysis Set)	223	225
Overall Study COMPLETED	220	221
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Desloratadine 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo 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.
Overall Study Adverse Event	2	2
Overall Study Pregnancy	0	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

Baseline characteristics by cohort

Measure	Desloratadine n=224 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.	Total n=449 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 10.9 • n=5 Participants	39.8 years STANDARD_DEVIATION 10.9 • n=7 Participants	39.9 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	131 Participants n=7 Participants	261 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	94 Participants n=7 Participants	188 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment

Population: The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks).

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy	-1.41 units on a scale Interval -1.64 to -1.19	-0.59 units on a scale Interval -0.81 to -0.36

PRIMARY outcome

Timeframe: Up to 4 weeks (Up to 2 weeks after last dose of study drug)

Population: All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Number of Participants Who Experience at Least One Adverse Event (AE)	19 participants	13 participants

PRIMARY outcome

Timeframe: Up to 2 weeks

Population: APaT; all participants who received ≥1 dose of study treatment.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Number of Participants Who Discontinue Study Drug Due to an AE	2 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment Week 1	-1.19 units on a scale Interval -1.42 to -0.96	-0.38 units on a scale Interval -0.61 to -0.15
Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment Week 2	-1.69 units on a scale Interval -1.96 to -1.41	-0.84 units on a scale Interval -1.12 to -0.57

SECONDARY outcome

Timeframe: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Sneezing	-0.39 units on a scale Interval -0.47 to -0.31	-0.14 units on a scale Interval -0.22 to -0.06
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Rhinorrhea	-0.34 units on a scale Interval -0.42 to -0.26	-0.13 units on a scale Interval -0.21 to -0.05
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Nasal Congestion	-0.02 units on a scale Interval -0.07 to 0.03	0.07 units on a scale Interval 0.03 to 0.12
Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Nasal Itching	-0.45 units on a scale Interval -0.53 to -0.36	-0.18 units on a scale Interval -0.26 to -0.09

SECONDARY outcome

Timeframe: Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Sneezing	-0.51 units on a scale Interval -0.6 to -0.42	-0.27 units on a scale Interval -0.35 to -0.18
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Rhinorrhea	-0.49 units on a scale Interval -0.58 to -0.4	-0.24 units on a scale Interval -0.33 to -0.16
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Nasal Congestion	-0.03 units on a scale Interval -0.09 to 0.03	0.06 units on a scale Interval 0.0 to 0.12
Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) Nasal Itching	-0.65 units on a scale Interval -0.75 to -0.55	-0.39 units on a scale Interval -0.49 to -0.29

SECONDARY outcome

Timeframe: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy Sneezing	-0.44 units on a scale Interval -0.52 to -0.37	-0.20 units on a scale Interval -0.27 to -0.12
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy Rhinorrhea	-0.41 units on a scale Interval -0.48 to -0.33	-0.18 units on a scale Interval -0.26 to -0.11
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy Nasal Congestion	-0.02 units on a scale Interval -0.07 to 0.03	0.07 units on a scale Interval 0.02 to 0.12
Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy Nasal Itching	-0.54 units on a scale Interval -0.62 to -0.46	-0.27 units on a scale Interval -0.36 to -0.19

SECONDARY outcome

Timeframe: Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) Eye Pruritus	-0.34 units on a scale Interval -0.41 to -0.26	-0.09 units on a scale Interval -0.17 to -0.01
Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) Watering Eyes	-0.17 units on a scale Interval -0.24 to -0.11	-0.02 units on a scale Interval -0.08 to 0.05
Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) Worse of Pruritus or Watering Eyes	-0.34 units on a scale Interval -0.42 to -0.27	-0.09 units on a scale Interval -0.17 to -0.01

SECONDARY outcome

Timeframe: Baseline, Day 8 to 13 (Week 2) of double-blind treatment

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) Eye Pruritus	-0.56 units on a scale Interval -0.66 to -0.46	-0.32 units on a scale Interval -0.41 to -0.22
Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) Watering Eyes	-0.26 units on a scale Interval -0.34 to -0.18	-0.13 units on a scale Interval -0.2 to -0.05
Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) Worse of Pruritus or Watering Eyes	-0.56 units on a scale Interval -0.66 to -0.46	-0.32 units on a scale Interval -0.41 to -0.22

SECONDARY outcome

Timeframe: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
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 Pruritus	-0.44 units on a scale Interval -0.52 to -0.36	-0.19 units on a scale Interval -0.27 to -0.12
Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy Watering Eyes	-0.21 units on a scale Interval -0.27 to -0.15	-0.07 units on a scale Interval -0.13 to 0.0
Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy Worse of Pruritus or Watering Eyes	-0.44 units on a scale Interval -0.52 to -0.36	-0.19 units on a scale Interval -0.27 to -0.12

SECONDARY outcome

Timeframe: 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

Population: The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.

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.

Outcome measures

Measure	Desloratadine n=223 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 Participants 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.
Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy Week 1	-0.23 units on a scale Interval -0.29 to -0.16	-0.07 units on a scale Interval -0.14 to -0.01
Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy Week 2	-0.34 units on a scale Interval -0.42 to -0.26	-0.14 units on a scale Interval -0.22 to -0.06
Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy 2 Week Average	-0.28 units on a scale Interval -0.34 to -0.21	-0.10 units on a scale Interval -0.17 to -0.04

SECONDARY outcome

Timeframe: From Baseline to Week 2

Population: Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.

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.

Outcome measures

Measure	Desloratadine n=222 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=224 Participants 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.
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 Much better	2.3 percentage of participants	3.1 percentage of participants
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 Better	26.1 percentage of participants	17.9 percentage of participants
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 Better + Much better Total	28.4 percentage of participants	21.0 percentage of participants
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2 Less than better Total	71.6 percentage of participants	79.0 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 2

Population: Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.

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.

Outcome measures

Measure	Desloratadine n=222 Participants 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=224 Participants 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.
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 Much better	5.9 percentage of participants	4.9 percentage of participants
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 Better	30.6 percentage of participants	16.1 percentage of participants
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 Better + Much better Total	36.5 percentage of participants	21.1 percentage of participants
Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2 Less than better Total	63.5 percentage of participants	78.9 percentage of participants

Adverse Events

Desloratadine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Desloratadine n=223 participants at risk 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) PO QD in the morning for 2 weeks during the Treatment Period.	Placebo n=225 participants at risk 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.
Infections and infestations Postoperative wound infection	0.45% 1/223 • Number of events 1 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) APaT; all participants who received ≥1 dose of study treatment. One participant randomized to Desloratadine was not treated due to withdrawn consent.	0.00% 0/225 • Up to 4 weeks (Up to 2 weeks after last dose of study drug) APaT; all participants who received ≥1 dose of study treatment. One participant randomized to Desloratadine was not treated due to withdrawn consent.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER