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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: Completed Phase 3 study of Rhinitis, Allergic, Seasonal, sponsored by Sandoz.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scor
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 |
What the finished NCT01038427 record still lists
NCT01038427 is an interventional study that assigns participants to a tested intervention. The registered 795 participants enrollment target is mid-sized for trials with a published cap, above the 594-participant average among 3 other Rhinitis, Allergic, Seasonal trials with a reported enrollment target (34% higher).
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 lists 8 locations in 1 state (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.
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