NCT02082054

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

A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Magna Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Actives in each of the five study arms: Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.36 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.24 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.12 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg Atropine 0.24 mg

Conditions

• Rhinitis, Seasonal, Allergic

Interventions

Type	Name	Description
DRUG	PSE 120 mg, CM 8 mg, Atr 0.36 mg	Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side
DRUG	PSE 120 mg, CM 8 mg, Atr 0.24 mg	Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
DRUG	PSE 120 mg, CM 8 mg, Atr 0.12 mg	Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with "M27" on scored side and plain on the other side
DRUG	PSE 120 mg, CM 8 mg	Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
DRUG	Atropine 0.24 mg	Atropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-03-10
• Last updated: 2014-05-30

Locations

4 sites across 1 country: United States