Trial Outcomes & Findings for Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684) (NCT NCT00405964)
NCT ID: NCT00405964
Last Updated: 2024-05-20
Results Overview
AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
COMPLETED
PHASE3
716 participants
Baseline and Days 1-29
2024-05-20
Participant Flow
Participant milestones
| Measure |
5-mg Desloratadine Tablet
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
Matching placebo, orally daily.
|
|---|---|---|
|
Overall Study
STARTED
|
360
|
356
|
|
Overall Study
COMPLETED
|
301
|
261
|
|
Overall Study
NOT COMPLETED
|
59
|
95
|
Reasons for withdrawal
| Measure |
5-mg Desloratadine Tablet
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
Matching placebo, orally daily.
|
|---|---|---|
|
Overall Study
Treatment Failure
|
17
|
45
|
|
Overall Study
Adverse Event
|
7
|
16
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
19
|
23
|
|
Overall Study
Protocol Violation
|
11
|
6
|
Baseline Characteristics
Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)
Baseline characteristics by cohort
| Measure |
5-mg Desloratadine Tablet
n=360 Participants
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
n=356 Participants
Matching placebo, orally daily.
|
Total
n=716 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
348 Participants
n=5 Participants
|
341 Participants
n=7 Participants
|
689 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
208 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 1-29Population: All randomized participants
AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
Outcome measures
| Measure |
5-mg Desloratadine Tablet
n=355 Participants
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
n=351 Participants
Matching placebo, orally daily.
|
|---|---|---|
|
Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment
Baseline
|
9.63 units on a scale
Standard Error 0.13
|
9.55 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment
Days 1-29
|
-3.76 units on a scale
Standard Error 0.22
|
-2.87 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: All randomized participants
The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
Outcome measures
| Measure |
5-mg Desloratadine Tablet
n=313 Participants
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
n=289 Participants
Matching placebo, orally daily.
|
|---|---|---|
|
Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment
Baseline
|
3.30 units on a scale
Standard Error 0.08
|
3.15 units on a scale
Standard Error 0.08
|
|
Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment
Day 29
|
-1.35 units on a scale
Standard Error 0.10
|
-0.95 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline and Days 1-85Population: All randomized participants
AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.
Outcome measures
| Measure |
5-mg Desloratadine Tablet
n=355 Participants
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
n=351 Participants
Matching placebo, orally daily.
|
|---|---|---|
|
Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment
Baseline
|
9.63 units on a scale
Standard Error 0.13
|
9.55 units on a scale
Standard Error 0.12
|
|
Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment
Days 1-85
|
-4.50 units on a scale
Standard Error 0.23
|
-3.61 units on a scale
Standard Error 0.23
|
Adverse Events
5-mg Desloratadine Tablet
Placebo Tablet
Serious adverse events
| Measure |
5-mg Desloratadine Tablet
n=360 participants at risk
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
n=356 participants at risk
Matching placebo, orally daily.
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/360
|
0.28%
1/356 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/360
|
0.28%
1/356 • Number of events 1
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.28%
1/360 • Number of events 1
|
0.00%
0/356
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/360
|
0.28%
1/356 • Number of events 1
|
Other adverse events
| Measure |
5-mg Desloratadine Tablet
n=360 participants at risk
Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
|
Placebo Tablet
n=356 participants at risk
Matching placebo, orally daily.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.6%
38/360 • Number of events 44
|
4.8%
17/356 • Number of events 18
|
|
Nervous system disorders
Headache
|
6.9%
25/360 • Number of events 45
|
10.4%
37/356 • Number of events 63
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60