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Sponsored by: |
Dey |
Information provided by: | Dey |
ClinicalTrials.gov Identifier: | NCT00552773 |
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
Condition | Intervention |
ACUTE SINUSITIS |
Drug: Cyclamen Europaeum |
MedlinePlus related topics: | Sinusitis |
ChemIDplus related topics: | Salicylsalicylic acid Sodium salicylate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Parallel Group Trial of Cyclamen Europaeum Extract Nasal Spray 10% (v/v) in the Treatment of Subjects With Acute Sinusitis |
Enrollment: | 48 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Cyclamen Europaeum: Experimental |
Drug: Cyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
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Placebo: Placebo Comparator |
Drug: Cyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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Show 25 Study Locations |
Dey |
Principal Investigator: | Angelique Barreto, MD | Memorial Clinical Reasearch, OK |
Responsible Party: | Dey, LP ( Director, Clinical Affairs ) |
Study ID Numbers: | 434-083 |
First Received: | October 31, 2007 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00552773 |
Health Authority: | United States: Food and Drug Administration |
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