Trial intelligence / Profile preview

ONO-1078 in Chronic Sinusitis

NCT00410735Phase 3

Key facts

Status: Completed
Start: Dec 2006
Primary completion: Jun 2008
Countries: 1
Sponsor: Ono Pharmaceutical
Modality: Small Molecules

Drugs: pranlukast
Conditions: sinusitis

Overview

Phase 3, randomised, double-blind trial in sinusitis comparing Pranlukast with Placebo (2 arms). Primary endpoints: Nasal congestion at 12 weeks, Rhinorrhea at 12 weeks and 1 more. Started Dec 2006; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Pranlukast
Pranlukast hydrate 225 mg BID
Placebo
Placebo 0 mg BID

Who it enrols

Patients with chronic sinusitis, excluding those with acute sinusitis or acute exacerbation.

Endpoints

Primary

Nasal congestion12 weeks
Rhinorrhea12 weeks
Postnasal drip12 weeks

Secondary

Easiness of blowing nose12 weeks
Easiness of removing postnasal drip12 weeks
Dull headache12 weeks

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