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Trial record 63 of 66 for:    Levocetirizine

The Duration of the Suppressive Effects of Desloratadine on Allergen Prick Tests After Discontinuation (P04441)

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ClinicalTrials.gov Identifier: NCT00359138
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : November 1, 2010
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypersensitivity
Interventions Drug: desloratadine
Drug: levocetirizine
Drug: Desloratadine placebo tablet
Drug: Levocetirizine placebo capsule
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Hide Arm/Group Description Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Period Title: Overall Study
Started 12 12 12
Completed 12 12 12
Not Completed 0 0 0
Arm/Group Title Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule Total
Hide Arm/Group Description Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 36 participants
23.42  (4.91) 28.33  (8.69) 28.83  (11.55) 26.86  (8.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
Female
5
  41.7%
8
  66.7%
5
  41.7%
18
  50.0%
Male
7
  58.3%
4
  33.3%
7
  58.3%
18
  50.0%
1.Primary Outcome
Title Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
Hide Description The number of days after treatment discontinuation until a measurable wheal and flare response.
Time Frame Starting at Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Hide Arm/Group Description:
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
Overall Number of Participants Analyzed 12 12 12
Mean (Standard Error)
Unit of Measure: Days
5  (1.65) 4  (1.60) NA [1]   (NA)
[1]

Results are based on the individual active group relative to placebo.

Not applicable for placebo relative to placebo

Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Hide Arm/Group Description Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
All-Cause Mortality
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/12 (41.67%)      4/12 (33.33%)      1/12 (8.33%)    
Gastrointestinal disorders       
Abdominal Pain Upper  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Dry Mouth  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Nausea  1  1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Vomiting  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
General disorders       
Asthenia  1  1/12 (8.33%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Infections and infestations       
Rhinitis  1  0/12 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders       
Muscle Contracture  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Nervous system disorders       
Headache  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Somnolence  1  1/12 (8.33%)  1 2/12 (16.67%)  2 0/12 (0.00%)  0
Psychiatric disorders       
Insomnia  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Reproductive system and breast disorders       
Dysmenorrhoea  1  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Cough  1  1/12 (8.33%)  1 1/12 (8.33%)  1 1/12 (8.33%)  1
Pharyngolaryngeal Pain  1  1/12 (8.33%)  1 0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00359138     History of Changes
Other Study ID Numbers: P04441
First Submitted: July 31, 2006
First Posted: August 1, 2006
Results First Submitted: May 27, 2010
Results First Posted: November 1, 2010
Last Update Posted: June 26, 2015