Phase 4
Completed N=340
The Efficacy of Claritin in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01451996 ↗
Enrolled (actual)
340
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Change in Wheal Reaction Area From Baseline --- 2 Hour — 27.5; 29.0; 30.97; 25.0 Percent change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary goal of this study is to examine determinants of the efficacy of Claritin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wheal Reaction Area From Baseline --- 2 Hour |
27.5; 29.0; 30.97; 25.0 | — |
| SECONDARY Change in Wheal Reaction Area From Baseline --- 1 Hour |
10.8; 17.5; 14.18; 10.83 | — |
Eligibility Criteria
Inclusion Criteria.
- Males and females between 18 and 65 years of age.
Exclusion Criteria.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
- Women of childbearing potential not using specific contraception method(s) (i.e., birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
- Use of any other investigational agent in the last 30 days.
- Use of medications that may affect skin testing. Specifically, subjects are excluded if they have used an antihistamine during the 4 days preceding their treatment visit.
Data sourced from ClinicalTrials.gov (NCT01451996). 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. Informational only — not medical advice.