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NCT01916226 · ClinicalTrials.gov registry record · Phase 4
A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 682
- Enrollment target
NCT01916226 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 682 participants.
The verdict
NCT01916226, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 682 participants
- Enrollment target
Study Summary
This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal symptom relief than cetirizine. The primary measure used to test this hypothesis is the change from baseline over two weeks in reflective total nasal symptom score (rTNSS) compared between FPNS and cetirizine. Approximately 648 subjects will be randomized into a 1:1:1:1 ratio of treatment allocation across approximately twenty-five to thirty-five sites in the US during the 2013 fall allergy season. All subjects will be outpatients. The total duration of study will be approximately 21 days including 7 days of screening period, and 14 days of treatment period.
Interventions
- DRUG Cetirizine
- DRUG FPNS
- DRUG FPNS Placebo
- DRUG Cetirizine Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2013-08-01 |
| Est. Completion | 2013-10-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01916226
The ClinicalTrials.gov registry entry for NCT01916226 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 682 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cetirizine is the first listed.
NCT01916226 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01916226 about?
NCT01916226 is a clinical study titled "A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis". This phase IV investigational trial is being conducted to evaluate the efficacy of a 2-week treatment of fluticasone propionate nasal spray (FPNS) vs. cetirizine on allergic nasal and ocular symptoms and quality of life in adult subjects with SAR. It is hypothesized that FPNS provides greater nasal ...
What is the current status of trial NCT01916226?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 682 participants. The study started on 2013-08-01. Estimated completion is 2013-10-17.
What interventions are being tested in trial NCT01916226?
The interventions under investigation include: Cetirizine (DRUG), FPNS (DRUG), FPNS Placebo (DRUG), Cetirizine Placebo (DRUG).
Who is sponsoring clinical trial NCT01916226?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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