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OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma

NCT00890877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2010-09-02

No results posted yet for this study

Summary

This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.

Conditions

  • Mild to Moderate Persistent Asthma

Interventions

DRUG

OC000459 or placebo

Pills, active and/or placebo given twice daily for 17 weeks

Sponsors & Collaborators

  • Oxagen Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-05-31
Completion
2010-07-31

Countries

  • Bulgaria
  • Hungary
  • Poland
  • Romania
  • Russia
  • Ukraine

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 NCT00890877 on ClinicalTrials.gov