Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00637585
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Duration (Months): 7
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Fexofenadine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Comparison of Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
• Study Start Date: Dec 1, 2002
• Actual Study Completion Date: Jul 1, 2003

Outcome Measures

Primary Outcome Measures

1. Size of change in summation skin flares from baseline will be measured. [Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24)]

Secondary Outcome Measures

1. Size of change in summation skin wheals from baseline will be measured. [Post-dose (20 min, 40 min, 60 min, and hourly through 12 hours with an additional 2 time points obtained at Hours 23 and 24).]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female subjects, 12 to 55 years of age, may participate

• Positive histamine skin prick tests (or duplicate histamine skin prick test) with a summation flare (ΣF) greater than or equal to 20 mm larger than diluent control, and summation wheal (ΣW) greater than or equal to 6 mm larger than diluent control at the screening visit 1

• All female subjects must have a negative urine pregnancy test at the screening visit

• Female subjects who are sexually active will be expected to use one of the following birth control methods throughout the study (see Section 4.4)

• Subjects must be within 15% of normal body weight for height or a BMI less than 29.9 (based on NHLBI guidelines)

• Subjects willing and able to adhere to visit schedules and all study requirements

• All female subjects must have a negative urine pregnancy test at each treatment visit (Visit 2, 4, and 6).

• Continues to meet all inclusion and exclusion criteria

Exclusion Criteria:

• Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist

• Signs and symptoms of currently active allergic disease (seasonal allergic rhinitis, perennial allergic rhinitis, episodic allergic rhinitis)

• Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1

• Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results

• Subjects who are receiving immunotherapy

• Any excessive amounts of alcohol (no more than two drinks/day on average)

• Any excessive use of caffeine (more than six cups of coffee per day or equivalent)

• Any use of tobacco/nicotine products within 90 days of visit 1

• Any disease state or surgery known to affect the gastrointestinal absorption of drugs

• Known hypersensitivity to the investigational product or to drugs with similar chemical properties

• Subjects who will be visiting a tanning salon during the study

• Subjects who will need to use artificial tanning products during the study

• Night or variable shift workers during the study

• Pregnancy

• Breast-feeding

• History of hypersensitivity to the study medications or to drugs with similar chemical structures

• Treatment with other H1-receptor antagonists in the last year before study entry

• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)

• Treatment with any investigational product in the last 30 days before study entry

• No person or child of a person directly associated with the administration of the study may participate as a study subject

• Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult

• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

• Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

• Use of any of the following drugs within the time indicated prior to the first dosing visit:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Phyllis Diener, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00637585
• Other Study ID Numbers: M016455A_4145
• First Posted: Mar 18, 2008
• Last Update Posted: Jan 11, 2011
• Last Verified: Jan 1, 2011

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Fexofenadine

Study Results

No Results Posted as of Jan 11, 2011