Phase 4
N=18
Safety Study of Levocetirizine and Fexofenadine
Pruritus · Chronic Urticaria · Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01586091 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Pruritus as Assessed by the VAS Score — 11.5; 25.4; 46.0 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levocetirizine Oral Tablet (Drug); Fexofenadine 60 Mg Oral Tablet (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Charite University, Berlin, Germany
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pruritus as Assessed by the VAS Score |
11.5; 25.4; 46.0 | — |
| PRIMARY Flaire Diameter (mm) |
69.4; 20.4; 39.9 | — |
| PRIMARY Wheal Volume (cm3) |
174.6; 35.2; 106.3 | — |
Summary
This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.
Eligibility Criteria
Inclusion Criteria
Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study
Exclusion Criteria
- None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
- No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
- Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01586091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.