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Preoperative Prednisone for Nasal Polypectomy
NCT00440219Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2010
- Primary completion
- Dec 2012
- Countries
- 1
- Sponsor
- Mount Sinai Hospital
- Modality
- Orthosteric Ligands
- Drugs
- prednisone
- Conditions
- nasal polyps
01
Overview
Phase 3, randomised, double-blind trial in nasal polyps comparing Prednisone group with Placebo group (2 arms). Primary endpoints: Intraoperative blood loss (Wormald Surgical Field Grading Scale), Visibility and ease of surgery and 1 more. Started Nov 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Prednisone group
Prednisone 50 mg daily for 10 days immediately pre-op
Placebo group
Placebo pill for 10 days immediately pre-operative
03
Who it enrols
Patients with severe obstructing nasal polyps scheduled for surgery. Excludes patients with uncontrolled diabetes, hypertension, congestive heart failure, acute/chronic systemic infection, cataracts, glaucoma, or hypersensitivity to prednisone.
04
Endpoints
Primary
Intraoperative blood loss (Wormald Surgical Field Grading Scale)
Visibility and ease of surgery
Peri-Operative Sinus Endoscopy score
Secondary
Sino-Nasal Outcome Test-22
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