A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
This study has been completed.
Sponsor:
Sandoz Inc.
Information provided by (Responsible Party):
Sandoz Inc.
ClinicalTrials.gov Identifier:
NCT01038427
First received: December 22, 2009
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
This study will compare the safety and efficacy of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations will be tested for superiority against a placebo nasal spray.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: Mometasone Furoate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis |
Resource links provided by NLM:
Further study details as provided by Sandoz Inc.:
Primary Outcome Measures:
- The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 1103 |
| Study Start Date: | December 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Mometasone Furoate Nasal Spray (Lek d.d.) |
Drug: Mometasone Furoate
Test product - 200 mcg per day
|
| Active Comparator: Nasonex® Nasal Spray |
Drug: Mometasone Furoate
Reference listed drug - 200 mcg per day
|
| Placebo Comparator: Placebo Nasal Spray |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- Signed informed consent form. For patients under the age of majority the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form.
- Documented positive allergic skin test to local pollen, performed within the past 12 months.
- A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms.
Exclusion Criteria:
- Females who are pregnant, lactating or likely to become pregnant during the study.
- History of asthma over the previous two years that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
- Patients with some nasal conditions, or with clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
- Upper respiratory tract infection or any untreated infections within the previous 30 days.
- Patient has started immunotherapy/changed the dose within 30 days of starting the study or has desensitization therapy to the seasonal allergen that is causing the allergic rhinitis within the previous 6 months.
- Patients with a history of tuberculosis, or with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of seasonal allergic rhinitis within 14 days of enrollment.
- The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox or measles.
- Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
- Planned travel outside of the local area for more than 2 consecutive days or 3 days in total.
- The patient has a history of alcohol or drug abuse.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038427
Locations
| United States, Texas | |
| Austin, Texas, United States, 78731/50/59 | |
| Kerrville, Texas, United States, 78028 | |
| Live Oak, Texas, United States, 78233 | |
| New Braunfels, Texas, United States, 78310 | |
| San Antonio, Texas, United States, 78229 | |
| Sylvana Research | |
| San Antonio, Texas, United States, 78229 | |
| Waco, Texas, United States, 76708 | |
Sponsors and Collaborators
Sandoz Inc.
More Information
No publications provided
| Responsible Party: | Sandoz Inc. |
| ClinicalTrials.gov Identifier: | NCT01038427 History of Changes |
| Other Study ID Numbers: | 70947201 |
| Study First Received: | December 22, 2009 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sandoz Inc.:
|
Rhinitis Allergic Seasonal Mometasone Furoate Equivalence |
Additional relevant MeSH terms:
|
Rhinitis, Allergic, Seasonal Rhinitis Signs and Symptoms Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Respiratory Tract Infections Mometasone furoate Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013