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NCT01880840 · ClinicalTrials.gov registry record · Phase 4
Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR
A Phase 4 study, sponsored by Meda Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 191
- Enrollment target
NCT01880840: Completed Phase 4 study, sponsored by Meda Pharmaceuticals.
NCT01880840 is a Phase 4 study that has completed, run by Meda Pharmaceuticals. The registered enrollment target is 191 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01880840, a Phase 4 study, has completed, sponsored by Meda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 191 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
Primary Outcome
The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to \<6 years of age with allergic rhinitis. Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments. Data for each age strata will be summarized separately as well as combined.
Interventions
- DRUG 205.5 mcg of azelastine hydrochloride
- DRUG 137 mcg of azelastine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-08 |
| Phase | Phase 4 |
What the finished NCT01880840 record still lists
NCT01880840 is an interventional study that assigns participants to a tested intervention. The registered 191 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 2 interventions - of which 205.5 mcg of azelastine hydrochloride is the first listed.
NCT01880840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01880840 about?
NCT01880840 is a clinical study titled "Safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray in Children Ages >6 Months to <6 Years With AR". The purpose of this study is to compare the safety of 2 different doses of the investigational use of an allergy medication (Astepro Nasal Spray) in the treatment of allergic rhinitis (AR). This is an open-label study; that is, parent and child will know which group each is in.
What is the current status of trial NCT01880840?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 191 participants. The study started on 2013-06. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01880840?
The interventions under investigation include: 205.5 mcg of azelastine hydrochloride (DRUG), 137 mcg of azelastine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01880840?
This trial is sponsored by Meda Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01880840's enrollment target sits among peer trials
191 453rd of 2000 higher than 1,548 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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