Comparative Study Evaluating the Effects of Fexofenadine HCI 180 mg With Orange Juice Versus Placebo With Orange Juice in a Skin Wheal and Flare Challenge Model.

NCT00547768 | Completed Phase 4

• 1 other identifier: M016455A_4144
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the effect of a single dose of fexofenadine HCl 180 mg plus orange juice versus placebo plus orange juice on the change from baseline (pre-dose) in histamine skin flares.

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• Size of change in skin flares from baseline measured at pre-specified times 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 Outcomes (1)

• Size and change in skin wheals from baseline measured at pre-specified time points.

  20 min, 40 min, 60 min, and hourly through 12 hours, with an additional 2 time points.

Interventions

Fexofenadine HCI DRUG

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy male or non-pregnant, non-lactating female subjects; 12-55 years of age; within 15% of normal body weight for their height or had a body mass index (BMI) less than 29.9 kg/m2; positive histamine skin prick tests (or a duplicate histamine skin prick test) of summation flare \> 20 mm larger than diluent control, and summation wheal \> 6 mm larger than diluent control at the screening Visit 1.

You may not qualify if:

• Asthma that required treatment with medication other than an inhaled, short-acting beta agonist
• Signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis)
• Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to Visit 1
• Dermatographism or other skin conditions that might interfere with the interpretation of the skin test results
• Treatment with escalating doses of immunotherapy, oral immunotherapy, or short course (rush) 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 history of chronic alcohol or mood-altering drug abuse
• 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
• Treatment with an H1-receptor antagonist regularly within the past year before study entry
• Known hypersensitivity to the investigational product or to drugs with similar chemical properties, or to orange juice
• Need to visit a tanning salon during the study
• Need to use artificial tanning products during the study
• Pregnancy

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Phyllis Diener

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: November 1, 2002
• Study Completion: December 1, 2002
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)