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OpenTrials
Completed

NCT Number: NCT00410735

Study of ONO-1078 in Patients With Chronic Sinusitis

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

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Key information

Conditions

Chronic Sinusitis

Age range

15 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu region, Chūbu, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic sinusitis

Exclusion criteria

  • acute sinusitis
  • chronic sinusitis with acute exacerbation

Treatment and study plan

Placebo

Drug

0 mg BID for 12 weeks

Pranlukast hydrate

Drug

225 mg BID for 12 weeks

Primary outcomes

  1. nasal congestion

    Time frame: 12 weeks

  2. rhinorrhea

    Time frame: 12 weeks

  3. postnasal drip

    Time frame: 12 weeks

Secondary outcomes

  1. easiness of blowing nose

    Time frame: 12 weeks

  2. easiness of removing postnasal drip

    Time frame: 12 weeks

  3. dull headache

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Study of ONO-1078 in Patients With Chronic Sinusitis, a Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study

Important dates

Study start
2006
Primary completion
2008
First posted
Dec 13, 2006
Registry last updated
Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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