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NCT01038427 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
A Phase 3 study of Rhinitis, Allergic, Seasonal, sponsored by Sandoz.
- Completed
- Registry status
- Phase 3
- Development phase
- 795
- Enrollment target
- 8
- Study locations
NCT01038427 is a Phase 3 study of Rhinitis, Allergic, Seasonal that has completed, run by Sandoz. The registered enrollment target is 795 participants, above the 594-participant average among 3 other Rhinitis, Allergic, Seasonal trials with a reported enrollment target (34% higher). The trial reports 8 study locations across 1 state.
The verdict
NCT01038427, a Phase 3 study of Rhinitis, Allergic, Seasonal, has completed, sponsored by Sandoz.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 795 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 795 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 594-participant average among 3 other Rhinitis, Allergic, Seasonal trials with a reported enrollment target (34% higher). The listed sponsor is Sandoz, which has 29 total studies on file at ClinicalTrials.gov.
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.
NCT01038427 reports 8 study locations spanning 1 distinct geographic area - top geographies include Texas.
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.
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).
Who is sponsoring clinical trial NCT01038427?
This trial is sponsored by Sandoz, which has 29 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Rhinitis, Allergic, Seasonal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)
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-
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
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-
Dose-ranging Study to Assess the Efficacy and Safety of Ciclesonide HFA Nasal Aerosol in Adult and Adolescent Patients 12 Years and Older With Seasonal Allergic Rhinitis (SAR) (BY9010/M1-602)
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.