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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00359138
• Collaborator: (none)
• Enrollment: 36
• Arms: 3
• Duration (Months): 2.9

Study Details

Study Description

Brief Summary

This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class > 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a mixture of five grass pollens. Subjects will be randomized to desloratadine 5 mg once daily, levocetirizine 5mg once daily, or placebo once daily for 8 days of treatment followed by 11 days of skin testing after discontinuation of the antihistamine treatment phase. The duration of the suppressive effects of desloratadine on cutaneous allergen-induced wheal and flare responses after discontinuation of a one-week treatment will be established.

Condition or Disease	Intervention/Treatment	Phase
Hypersensitivity	Drug: desloratadine; Drug: levocetirizine; Drug: Desloratadine placebo tablet; Drug: Levocetirizine placebo capsule	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Double-dummy, Parallel-group, Placebo-controlled, Randomized Study to Assess the Duration of the Suppressive Effects of Desloratadine on the Cutaneous Allergen-induced Wheal and Flare (1) Response After Discontinuation
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: May 1, 2006
• Actual Study Completion Date: May 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: desloratadine; 5 mg tablet once daily; Drug: Levocetirizine placebo capsule; once daily
Active Comparator: 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).	Drug: levocetirizine; 5 mg capsule once daily; Drug: Desloratadine placebo tablet; once daily
Placebo Comparator: 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).	Drug: Desloratadine placebo tablet; once daily; Drug: Levocetirizine placebo capsule; once daily

Outcome Measures

Primary Outcome Measures

1. Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment [Starting at Day 8]

   The number of days after treatment discontinuation until a measurable wheal and flare response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects must be 18 years of age or older, of either sex.

• Subjects must have at least a history of positive skin testing to the allergens of tree pollen, grass pollen, house dust mite, or cat dander.

• Non symptomatic volunteers allergic of different pollen they must be included out of the specific pollinic season.

• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.

• Subjects must understand and be able to adhere to visit schedules

• Subjects must be in general good health.

• Women of child-bearing potential must have a negative pregnancy test at Day -1 and must use an accepted method of contraception during the entire duration of the study.

Exclusion Criteria:

• Subjects who have persistent asthma.

• Subjects who have chronic urticaria or atopic dermatosis.

• Subjects who have received any treatment listed below more recently than the indicated washout period prior to Randomization, or who must continue to receive treatment as listed below.

Medications Prohibited During the Trial and Washout Period Prior to Visit 1

• Corticosteroids

• Intramuscular or intra-articular, 1 month

• Oral, inhaled, intravenous, rectal, intranasal, or ocular, 7 days

• High-potency dermatological, 7 days

• Cromolyn/Lodoxamide/Nedocromil

• Intranasal, ocular, inhaled, or oral, 2 days

• Antihistamines

• Long-acting prescription (eg, levocetirizine, fexofenadine, and desloratadine), 15 days

• Short-acting (eg, chlorpheniramine, brompheniramine including over-the-counter [OTC] forms, hydroxyzine), 15 days

• Ocular (eg, levocabastine), 15 days

• Leukotriene inhibitors (eg, montelukast), 7 days

• Systemic antibiotics, 14 days (the washout refers to antibiotics used to treat an upper or lower respiratory tract infection)

• Immunotherapy (desensitization), 1 year

• Decongestants

• oral, 2 days

• local, 2 days

• Ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs; eg, Toradol), 5 days

• Investigational medications, 30 days

• Tricyclic antidepressants (eg, amitriptyline, clomipramine, doxepin, imipramine, trimipramine, amoxapine, desipramine, nortriptyline, protriptyline), 30 days

• Tetracyclic antidepressants (eg, maprotiline, mirtazapine), 30 days

• Subjects with a history of hypersensitivity to desloratadine, to levocetirizine, or any of their excipients.

• Women who are breast-feeding, pregnant, or intend to become pregnant.

• Subjects with any clinically significant condition or situation, other than the condition being studied, that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

• Subjects who have used any investigational drugs within 30 days of randomization.

• Subjects working between 11 PM and 8 AM (night shift).

• Subjects who have skin/color pigmentation incompatible with accurate measurements of flare reaction.

• Subjects with cutaneous hyperactivity: negative prick test control >3 mm.

• Subjects who are participating in any other clinical study.

• Subjects who are part of the staff personnel directly involved with this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00359138
• Other Study ID Numbers: P04441
• First Posted: Aug 1, 2006
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Histamine H1 Antagonists; Anti-Allergic Agents
• Additional relevant MeSH terms: Hypersensitivity; Cetirizine; Loratadine; Levocetirizine; Desloratadine

Study Results

Participant Flow

Arm/Group Title	Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
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

Baseline Characteristics

Arm/Group Title	Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule	Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule	Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule	Total
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 Participants	12	12	12	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.42 (4.91)	28.33 (8.69)	28.83 (11.55)	26.86 (8.91)
Sex: Female, Male (Count of Participants)
Female	5 41.7%	8 66.7%	5 41.7%	18 50%
Male	7 58.3%	4 33.3%	7 58.3%	18 50%

Outcome Measures

1. Primary Outcome

Title	Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment
Description	The number of days after treatment discontinuation until a measurable wheal and flare response.
Time Frame	Starting at Day 8

Outcome Measure Data

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
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).
Measure Participants	12	12	12
Mean (Standard Error) [Days]	5 (1.65)	4 (1.60)	NA (NA)

Adverse Events

Arm/Group Title	Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule		Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule		Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
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%)		0/12 (0%)		0/12 (0%)
Other (Not Including 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	5/12 (41.7%)		4/12 (33.3%)		1/12 (8.3%)
Gastrointestinal disorders
Abdominal Pain Upper	1/12 (8.3%)	1	0/12 (0%)	0	0/12 (0%)	0
Dry Mouth	0/12 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Nausea	1/12 (8.3%)	1	1/12 (8.3%)	1	0/12 (0%)	0
Vomiting	0/12 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
General disorders
Asthenia	1/12 (8.3%)	1	1/12 (8.3%)	1	0/12 (0%)	0
Infections and infestations
Rhinitis	0/12 (0%)	0	1/12 (8.3%)	1	1/12 (8.3%)	1
Musculoskeletal and connective tissue disorders
Muscle Contracture	0/12 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Nervous system disorders
Headache	1/12 (8.3%)	1	0/12 (0%)	0	0/12 (0%)	0
Somnolence	1/12 (8.3%)	1	2/12 (16.7%)	2	0/12 (0%)	0
Psychiatric disorders
Insomnia	0/12 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Reproductive system and breast disorders
Dysmenorrhoea	1/12 (8.3%)	1	0/12 (0%)	0	0/12 (0%)	0
Respiratory, thoracic and mediastinal disorders
Asthma	0/12 (0%)	0	1/12 (8.3%)	1	0/12 (0%)	0
Cough	1/12 (8.3%)	1	1/12 (8.3%)	1	1/12 (8.3%)	1
Pharyngolaryngeal Pain	1/12 (8.3%)	1	0/12 (0%)	0	1/12 (8.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.