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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00344942 |
Purpose
To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinitis
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis |
Drug: triamcinolone acetonide Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomised, Double-Blind, French Multi-Centre Study, to Evaluate the Efficacy and Tolerance, in Comparison With Placebo, of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults |
| Enrollment: | 77 |
| Study Start Date: | April 2006 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: triamcinolone acetonide
220µg/day or a double spray into each nostril once daily for 12 weeks'treatment
|
| 2: Placebo Comparator |
Drug: placebo
a double spray into each nostril once daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | TRICA-L-00872, EudraCT #: 2006-000059-16 |
| Study First Received: | June 26, 2006 |
| Last Updated: | December 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00344942 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Rhinitis Triamcinolone diacetate Immunosuppressive Agents |
Hormones Glucocorticoids Nose Diseases Pharmacologic Actions Triamcinolone hexacetonide Triamcinolone Acetonide Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Triamcinolone |