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Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis

NCT00758446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-03-13

No results posted yet for this study

Summary

This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.

The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

BLX-028914

50 mg capsules, p.o, daily, 14 days

DRUG

BLX-028914

15 mg capsules, p.o, daily, 14 days

DRUG

placebo

capsules, p.o, daily, 14 days

Sponsors & Collaborators

  • Orexo AB

    collaborator INDUSTRY

  • Dart NeuroScience, LLC

    lead INDUSTRY

Principal Investigators

  • Lennart Greiff, MD, PhD · Department of otorhinolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

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 NCT00758446 on ClinicalTrials.gov