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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.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00637585
First received: March 10, 2008
Last updated: January 10, 2011
Last verified: January 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637585     History of Changes
Other Study ID Numbers: M016455A_4145
Study First Received: March 10, 2008
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014