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A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
NCT01038427 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)
- DRUG Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray
Study Locations (8)
Texas
- — Austin
- — Austin
- — Kerrville
- — Live Oak
- — New Braunfels
- Sylvana Research — San Antonio
- — San Antonio
- — Waco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 795 participants |
| Start Date | 2009-12-02 |
| Est. Completion | 2010-02-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01038427
The ClinicalTrials.gov registry entry for NCT01038427 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 795 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sandoz, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Rhinitis, Allergic, Seasonal appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01038427 reports 8 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01038427 about?
NCT01038427 is a clinical study titled "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 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.
What is the current status of trial NCT01038427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 795 participants. The study started on 2009-12-02. Estimated completion is 2010-02-16.
What conditions does trial NCT01038427 study?
This clinical trial studies the following conditions: Rhinitis, Allergic, Seasonal. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01038427?
The interventions under investigation include: Placebo (DRUG), Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) (DRUG), Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01038427?
This trial is sponsored by Sandoz, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01038427 being conducted?
This trial has 8 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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