A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Public ClinicalTrials.gov record NCT01038427. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study compared the efficacy and safety 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 were tested for superiority against a placebo nasal spray.
Study identification
- NCT ID
- NCT01038427
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 795 participants
Conditions and interventions
Conditions
Interventions
- Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) Drug
- Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2009
- Primary completion
- Feb 15, 2010
- Completion
- Feb 15, 2010
- Last update posted
- Feb 2, 2021
2009 – 2010
United States locations
- U.S. sites
- 8
- U.S. states
- 1
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Austin | Texas | 78731 | — |
| Not listed | Austin | Texas | 78759 | — |
| Not listed | Kerrville | Texas | 78028 | — |
| Not listed | Live Oak | Texas | 78233 | — |
| Not listed | New Braunfels | Texas | 78310 | — |
| Sylvana Research | San Antonio | Texas | 78229 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Waco | Texas | 76708 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01038427, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01038427 live on ClinicalTrials.gov.