drugset / Trial / NCT02082054

StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study

NCT02082054

Phase 2 Unknown 125 enrolled Magna Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p \< 0.05.

Timeline

Start
2014-03
Primary completion
2014-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Atropine Other / unclassified 0.12 mg
Subject Atropine Other / unclassified 0.24 mg
Subject Atropine Other / unclassified 0.36 mg
Subject Chlorpheniramine Unknown 8 mg
Subject Pseudoephedrine Small molecule 120 mg