drugset / Trial / NCT02082054
StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |