Trial Outcomes & Findings for The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441) (NCT NCT00359138)
NCT ID: NCT00359138
Last Updated: 2022-02-09
Results Overview
The number of days after treatment discontinuation until a measurable wheal and flare response.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
Starting at Day 8
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)
Baseline characteristics by cohort
| Measure |
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule
n=12 Participants
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule
n=12 Participants
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
n=12 Participants
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.42 years
STANDARD_DEVIATION 4.91 • n=93 Participants
|
28.33 years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
28.83 years
STANDARD_DEVIATION 11.55 • n=27 Participants
|
26.86 years
STANDARD_DEVIATION 8.91 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Starting at Day 8The number of days after treatment discontinuation until a measurable wheal and flare response.
Outcome measures
| Measure |
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule
n=12 Participants
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule
n=12 Participants
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
n=12 Participants
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
|---|---|---|---|
|
Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
|
5 Days
Standard Error 1.65 • Interval 0.4613 to 0.94
|
4 Days
Standard Error 1.60
|
NA Days
Standard Error NA
Results are based on the individual active group relative to placebo.
Not applicable for placebo relative to placebo
|
Adverse Events
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule
n=12 participants at risk
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule
n=12 participants at risk
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
n=12 participants at risk
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
General disorders
Asthenia
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Infections and infestations
Rhinitis
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Nervous system disorders
Somnolence
|
8.3%
1/12 • Number of events 1
|
16.7%
2/12 • Number of events 2
|
0.00%
0/12
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60