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

NCT00359138 | Completed Phase 4 Results

• 1 other identifier: P04441
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity

Keywords

Histamine H1 Antagonists; Anti-Allergic Agents

Outcome Measures

Primary Outcomes (1)

• Duration of Suppressive Effect of Desloratadine After Discontinuation of a 1-week Treatment

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

  Starting at Day 8

Study Arms (3)

Desloratadine 5 mg tablet + Levocetirizine placebo capsule

EXPERIMENTAL

Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

Drug: desloratadine; Drug: Levocetirizine placebo capsule

Desloratadine placebo tablet + Levocetirizine 5 mg capsule

ACTIVE COMPARATOR

Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).

Drug: levocetirizine; Drug: Desloratadine placebo tablet

Desloratadine placebo tablet + Levocetirizine placebo capsule

PLACEBO COMPARATOR

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; Drug: Levocetirizine placebo capsule

Interventions

desloratadine DRUG

5 mg tablet once daily

Desloratadine 5 mg tablet + Levocetirizine placebo capsule

levocetirizine DRUG

5 mg capsule once daily

Desloratadine placebo tablet + Levocetirizine 5 mg capsule

Desloratadine placebo tablet DRUG

once daily

Desloratadine placebo tablet + Levocetirizine 5 mg capsule; Desloratadine placebo tablet + Levocetirizine placebo capsule

Levocetirizine placebo capsule DRUG

once daily

Desloratadine 5 mg tablet + Levocetirizine placebo capsule; Desloratadine placebo tablet + Levocetirizine placebo capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypersensitivity

Interventions

desloratadine; levocetirizine

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2006
• First Posted: August 1, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 9, 2022
• Results First Posted: November 1, 2010

Record last verified: 2022-02