Systemic Methylprednisolone in Chronic Rhinosinusitis

PHASE4CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

April 30, 2010

Conditions
Chronic RhinosinusitisChildren
Interventions
DRUG

methylprednisolone

Patients enrolled in the study were given either oral amoxicillin/clavulanate (AMX/C) or metylprednisolone (MP) (group MP) or AMX/C and placebo (group P) twice daily using a random allocation chart based on a table of random numbers. Oral AMX/C was administered 45/6.4 mg/kg/d (maximum 2000/285 mg/d) for 30 days for both groups. Oral MP was administered for the first 15 days: 1 mg/kg/d (maximum 40 mg/d) for 10 days, 0.75 mg/kg/d for 2 days, 0.5 mg/kg/d for 2 days, and 0.25 mg/kg/d for 1 day. Placebo tablets contained lactose and were of same size and color as MP tablets.

Trial Locations (1)

06500

Gazi University Faculty of Medicine, Ankara

All Listed Sponsors
lead

Ondokuz Mayıs University

OTHER

NCT01205984 - Systemic Methylprednisolone in Chronic Rhinosinusitis | Biotech Hunter | Biotech Hunter