OC000459 Dose Finding Study in Hay Fever Sufferers.

NCT00697281 | Completed Phase 2

• 1 other identifier: OC000459/010/07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate a range of dose levels for efficacy in the control of symptoms of allergic rhinitis

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; human; clinical trial; efficacy; safety; challenge test

Outcome Measures

Primary Outcomes (1)

• Total nasal symptom score (TNSS)

  After 8 days of treatment

Secondary Outcomes (1)

• Other symptom scores of allergic rhinitis

  After 8 days of treatment

Study Arms (5)

1

EXPERIMENTAL

Dose level 1

Drug: OC000459

2

EXPERIMENTAL

Dose level 2

Drug: OC000459

3

EXPERIMENTAL

Dose level 3

Drug: OC000459

4

EXPERIMENTAL

Dose level 4

Drug: OC000459

5

EXPERIMENTAL

Dose level 5

Drug: Placebo

Interventions

OC000459 DRUG

Tablets twice daily for 8 days Dose level 1

1

Placebo DRUG

Tablets twice daily for 8 days Dose level 5

5

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
• Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception and must have a negative pregnancy test (blood or urine) at screening.
• Acceptable contraception includes the use of TWO of the following:
• oral contraception (i.e. the Pill);
• intrauterine device (an IUD or 'Coil');
• barrier contraception (i.e. condoms or diaphragm/cap);
• transdermal patch

You may not qualify if:

• Medical conditions likely to affect the outcome of the study.
• Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases as determined by the principal investigator or designee.
• Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
• Immunotherapy treatment course in the past 28 days
• Use of inhaled or local corticosteroids in the past 28 days.

Sponsors & Collaborators

• Oxagen Ltd: lead

Study Sites (1)

Allergie Zentrum Wien West, Vienna Challenge Chamber

Vienna, 1150 VIENNA, Austria

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Univ Prof. Dr. Friedrich Horak, MD

  Allergie Zentrum Wien West

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

AU (1)