Trial Outcomes & Findings for Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849) (NCT NCT00536380)

Last Updated: 2024-05-23

Results Overview

The UAS is a composite diary-recorded score. The diary recorded scores included wheal score and pruritus score with numeric severity intensity ratings of 0 = none to 3 = intense. The scoring was to be done twice daily within one hour of arising and in the evening, approximately 12 hours later. Scoring was "reflective", covering the 12-hour period since the previous recording. The daily UAS is the average of the morning and evening scores. The final week by definition was the terminal week. It was the last week participants stayed for the treatment period.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

314 participants

Primary outcome timeframe

Baseline and 4 treatment weeks

Results posted on

2024-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	5-mg Desloratadine 5-mg Desloratadine once daily	10-mg Desloratadine 10-mg Desloratadine once daily	20-mg Desloratadine 20-mg Desloratadine once daily
Overall Study STARTED	106	104	104
Overall Study COMPLETED	94	95	94
Overall Study NOT COMPLETED	12	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	5-mg Desloratadine 5-mg Desloratadine once daily	10-mg Desloratadine 10-mg Desloratadine once daily	20-mg Desloratadine 20-mg Desloratadine once daily
Overall Study Adverse Event	0	2	2
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal unrelated to study drug	2	0	1
Overall Study Withdrawal related to study drug	7	5	2
Overall Study Noncompliance with protocol	3	2	2
Overall Study Did not meet protocol eligibility	0	0	1
Overall Study Administrative	0	0	1

Baseline Characteristics

Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-mg Desloratadine n=106 Participants 5-mg Desloratadine once daily	10-mg Desloratadine n=104 Participants 10-mg Desloratadine once daily	20-mg Desloratadine n=104 Participants 20-mg Desloratadine once daily	Total n=314 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 12.8 • n=5 Participants	40.4 years STANDARD_DEVIATION 13.3 • n=7 Participants	40.1 years STANDARD_DEVIATION 14.2 • n=5 Participants	40.6 years STANDARD_DEVIATION 13.4 • n=4 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	69 Participants n=7 Participants	70 Participants n=5 Participants	209 Participants n=4 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	35 Participants n=7 Participants	34 Participants n=5 Participants	105 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 4 treatment weeks

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	5-mg Desloratadine n=104 Participants 5-mg Desloratadine once daily	20-mg Desloratadine n=100 Participants 20-mg Desloratadine once daily	10-mg Desloratadine n=104 Participants 10-mg Desloratadine once daily
Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg Change from Baseline in UAS	-1.0 Units on a scale Standard Error 0.12	-1.0 Units on a scale Standard Error 0.12	-1.1 Units on a scale Standard Error 0.12
Change in the Urticaria Activity Score (UAS) From Baseline to the Final Week for Desloratadine 5 mg Versus Desloratadine 20 mg Baseline UAS (mean +/- standard deviation)	2.9 Units on a scale Standard Error 0.82	2.8 Units on a scale Standard Error 0.74	2.9 Units on a scale Standard Error 0.77

Adverse Events

10-mg Desloratadine

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

20-mg Desloratadine

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

5-mg Desloratadine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	10-mg Desloratadine n=104 participants at risk 10-mg Desloratadine once daily	20-mg Desloratadine n=104 participants at risk 20-mg Desloratadine once daily	5-mg Desloratadine n=106 participants at risk 5-mg Desloratadine once daily
Infections and infestations Pneumonia	0.96% 1/104 • Number of events 1	0.00% 0/104	0.00% 0/106
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/104	0.96% 1/104 • Number of events 1	0.00% 0/106

Other adverse events

Other adverse events
Measure	10-mg Desloratadine n=104 participants at risk 10-mg Desloratadine once daily	20-mg Desloratadine n=104 participants at risk 20-mg Desloratadine once daily	5-mg Desloratadine n=106 participants at risk 5-mg Desloratadine once daily
Nervous system disorders Headache	3.8% 4/104 • Number of events 5	5.8% 6/104 • Number of events 9	4.7% 5/106 • Number of events 6

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI agrees not to publish or publicly present any interim results of Study without prior written consent of sponsor. PI further agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation to permit sponsor to review copies of abstracts or manuscripts for publication (including, without limitation, slides and text of oral or other public presentations and text of any transmission through any electronic media) which report any results of Study.
Publication restrictions are in place

Restriction type: OTHER