Allergic Rhinitis
Conditions
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.
Interventions
DRUGFexofenadine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). |
Countries
United States
Outcome results
None listed