Study of ONO-1078 in Patients With Chronic Sinusitis

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chronic Sinusitis

Treatments: Drug: Placebo; Drug: Pranlukast hydrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410735

ONO-1078-37

Details and patient eligibility

About

To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a double-blind, randomized, placebo-controlled, parallel group, multi-center study

Enrollment: 495 patients

Sex: All

Ages: 15 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic sinusitis

Exclusion criteria

• acute sinusitis
• chronic sinusitis with acute exacerbation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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495 participants in 2 patient groups, including a placebo group

P

Placebo Comparator group

Treatment:

Drug: Placebo

E

Experimental group

Treatment:

Drug: Pranlukast hydrate