Trial Outcomes & Findings for Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683) (NCT NCT00406783)

Results Overview

AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

547 participants

Primary outcome timeframe

15 days

Results posted on

2024-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	5-mg Desloratadine Tablet 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet placebo tablet, once daily for 15 days
Overall Study STARTED	276	271
Overall Study COMPLETED	262	256
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	5-mg Desloratadine Tablet 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet placebo tablet, once daily for 15 days
Overall Study Adverse Event	4	4
Overall Study Treatment Failure	2	3
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	1	4
Overall Study Protocol Violation	4	4

Baseline Characteristics

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-mg Desloratadine Tablet n=276 Participants 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet n=271 Participants placebo tablet, once daily for 15 days	Total n=547 Participants Total of all reporting groups
Age, Continuous	33.8 years STANDARD_DEVIATION 12.0 • n=5 Participants	34.6 years STANDARD_DEVIATION 12.8 • n=7 Participants	34.2 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	154 Participants n=5 Participants	164 Participants n=7 Participants	318 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	107 Participants n=7 Participants	229 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 days

Population: Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.

AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	5-mg Desloratadine Tablet n=271 Participants 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet n=265 Participants placebo tablet, once daily for 15 days
The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15	-3.01 scores on a scale Standard Error 0.21	-2.13 scores on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 15 days

Population: Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects \>=18 years of age and where available in the local language.

The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.

Outcome measures

Outcome measures
Measure	5-mg Desloratadine Tablet n=250 Participants 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet n=248 Participants placebo tablet, once daily for 15 days
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit	-1.1 scores on a scale Standard Error 0.1	-0.73 scores on a scale Standard Error 0.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Last Observation Carried Forward (LOCF) to the final visit. All randomized subjects with a non-missing baseline and at least some post-baseline data were included in the analyses.

AM/PM is the average of separate morning (AM) and evening (PM) evaluations. T5SS = the sum of the individual scores for nasal congestion/stuffiness, sneezing, rhinorrhea/nasal discharge, nasal pruritis, and ocular pruritis. Each individual symptom/sign was scored from 0 (none) to 3 (severe).

Outcome measures

Outcome measures
Measure	5-mg Desloratadine Tablet n=271 Participants 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet n=265 Participants placebo tablet, once daily for 15 days
Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE	8.5 scores on a scale Standard Error 0.14	8.33 scores on a scale Standard Error 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: Last Observation Carried Forward (LOCF) to the final visit. The RQLQ-S was only completed for subjects \>=18 years of age and where available in the local language.

The RQLQ-S questionnaire consists of 28 questions grouped into 7 domains. Each question is scored on a scale of 0 (not troubled with symptoms) to 6 (extremely troubled with symptoms). The total RQLQ-S score is the average score of the 28 questions which consisted of a total of 7 domains.

Outcome measures

Outcome measures
Measure	5-mg Desloratadine Tablet n=250 Participants 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet n=248 Participants placebo tablet, once daily for 15 days
Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE	2.96 scores on a scale Standard Error 0.08	2.80 scores on a scale Standard Error 0.08

Adverse Events

5-mg Desloratadine Tablet

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo Tablet

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	5-mg Desloratadine Tablet n=276 participants at risk 5 mg desloratadine tablet, once daily for 15 days	Placebo Tablet n=271 participants at risk placebo tablet, once daily for 15 days
Nervous system disorders Headache	6.5% 18/276 • Number of events 23 Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"	6.3% 17/271 • Number of events 21 Subjects were questioned and/or examined by the investigator for evidence of adverse events. The questioning of subjects with regard to the possible occurrence of adverse events were to be generalized such as, "How have you been feeling since your last visit?"

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 must provide sponsor w/ review copies of abstracts or manuscripts for publication that report any results of the study, 45 days before submission for publication or presentation. The sponsor shall have the right to review/comment on the material. If the parties disagree about the appropriateness of the material, PI must meet with sponsor's representatives before submission for publication, for the purpose of making good faith efforts to discuss and resolve any issues of disagreement.
Publication restrictions are in place

Restriction type: OTHER