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Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine
This study has been completed.
First Received: March 10, 2008   Last Updated: March 11, 2008   History of Changes
Sponsor: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00637585
  Purpose

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 Intervention Phase
Allergic Rhinitis
Drug: Fexofenadine
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Crossover Assignment
Official Title: A Comparison of Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Size of change in summation skin flares from baseline will be measured. [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Size of change in summation skin wheals from baseline will be measured. [ Time Frame: 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). ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: December 2002
Study Completion Date: July 2003
  Eligibility

Ages Eligible for Study:   12 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637585

Locations
United States, New Jersey
Sanofi-aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Phyllis Diener Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Responsible Party: sanofi-aventis ( Study Director )
Study ID Numbers: M016455A/4145
Study First Received: March 10, 2008
Last Updated: March 11, 2008
ClinicalTrials.gov Identifier: NCT00637585     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Rhinitis
Anti-Allergic Agents
Cholinergic Agents
Desloratadine
Nose Diseases
Pharmacologic Actions
Respiratory Tract Diseases
Respiratory Tract Infections
Histamine Antagonists
Therapeutic Uses
Fexofenadine
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on February 08, 2010