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

NCT02082054 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2014-05-30

No results posted yet for this study

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.

Conditions

  • Rhinitis, Seasonal, Allergic

Interventions

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

Sponsors & Collaborators

  • Magna Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen J Pollard, MD · Family Allergy and Asthma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02082054 on ClinicalTrials.gov