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NCT00883168 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
A Phase 3 study, sponsored by Meda Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,791
- Enrollment target
NCT00883168: Completed Phase 3 study, sponsored by Meda Pharmaceuticals.
NCT00883168 is a Phase 3 study that has completed, run by Meda Pharmaceuticals. The registered enrollment target is 1,791 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00883168, a Phase 3 study, has completed, sponsored by Meda Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,791 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).
Primary Outcome
change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement.
Interventions
- DRUG Placebo
- DRUG fluticasone propionate
- DRUG azelastineHcl
- DRUG azelastine Hcl/fluticasone propionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,791 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00883168 record still lists
NCT00883168 is an interventional study that assigns participants to a tested intervention. Its 1,791 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00883168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00883168 about?
NCT00883168 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies". The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).
What is the current status of trial NCT00883168?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,791 participants. The study started on 2009-04. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00883168?
The interventions under investigation include: Placebo (DRUG), fluticasone propionate (DRUG), azelastineHcl (DRUG), azelastine Hcl/fluticasone propionate (DRUG).
Who is sponsoring clinical trial NCT00883168?
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 NCT00883168's enrollment target sits among peer trials
1,791 125th of 2000 higher than 1,876 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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