Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
- Registration Number
- NCT00447837
- Lead Sponsor
- Naryx Pharma
- Brief Summary
The primary objective of the study is to evaluate the safety and efficacy of SPRC-AB01 versus placebo for treatment of chronic sinusitis in subjects who have had sinus surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Outpatient subjects who have signed a written informed consent.
- A documented history of chronic sinusitis with clinical signs and symptoms suggestive of inflammation or infection for at least 90 consecutive days.
- A documented history of sinus surgery > 90 days.
- Nasal endoscopic exam documenting purulence (pus) from an open sinus cavity with mucosal swelling/edema.
- Women of childbearing potential must have a negative serum pregnancy test and must use adequate birth control throughout the study.
- Pregnant females and females unwilling to use adequate birth control.
- Use of any investigational drug/device within 30 days of study screening.
- The following medications will require a certain washout period as determined by the protocol: systemic corticosteroids, mast cells and/or leukotriene inhibitors, anti-inflammatories, decongestants, antihistamines, non-steroidal anti-inflammatory (NSAID) or cyclooxygenase (COX)-2 inhibitors, antibiotics or antifungals.
- Presence of other infections which may require use of systemic antibiotics.
- Known allergy or hypersensitivity to aminoglycosides or other study drug formulation components.
- Recent hospitalization for any reason and/or major surgeries within 30 days of study screening.
- Major elective and/or nasal and/or sinus surgical procedures (including sinuplasty) within 90 days before or 90 days after study screening.
- Known history of neurological or muscular disorders.
- Diagnosis of an immunodeficiency disease.
- Previous diagnosis of cystic fibrosis, ciliary dyskinesias, Kartagener syndrome, empty nose syndrome, Wegener granulomatosis, Churg-Strauss syndrome, Samter syndrome, or sarcoidosis.
- Current or known history of tinnitus, vertigo, or significant sensorineural hearing loss.
- Recent history of alcohol or drug abuse.
- Inability to understand the nature, scope, and possible consequences of the study or study procedures, unless cared for by a legally authorized representative.
- Inability to adhere to the study requirements.
- Previous participation in any Naryx Pharma protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 SPRC-AB01 - 2 SPRC-AB01 - 3 SPRC-AB01 -
- Primary Outcome Measures
Name Time Method Change from baseline in TSSS during first week post-therapy 86 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Allergy Research Foundation, Inc
🇺🇸Los Angeles, California, United States
Allergy & Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Allergy and Asthma Associates
🇺🇸Houston, Texas, United States
Cleveland Clinic - Head & Neck Institute
🇺🇸Cleveland, Ohio, United States
San Antonio Ear, Nose and Throat Research
🇺🇸San Antonio, Texas, United States
Clinical Research Consultants
🇺🇸Hoover, Alabama, United States
Commonwealth Ear, Nose & Throat
🇺🇸Louisville, Kentucky, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Toledo Center for Clinical Research
🇺🇸Sylvania, Ohio, United States
University of Rochester-Otolaryngology Associates
🇺🇸Rochester, New York, United States
Calvert Internal Medicine Group
🇺🇸Prince Frederick, Maryland, United States
Ear, Nose & Throat Associates of Corpus Christi / Research
🇺🇸Corpus Christi, Texas, United States
Charlotte Eye, Ear, Nose & Throat Associates
🇺🇸Charlotte, North Carolina, United States
Research Across America
🇺🇸Plano, Texas, United States
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Central California Clinical Research
🇺🇸Fresno, California, United States
Allergy Medical Group of the North Area Inc
🇺🇸Roseville, California, United States
Sacramento Ear, Nose & Throat
🇺🇸Sacramento, California, United States
The Connecticut Sinus Center
🇺🇸Bridgeport, Connecticut, United States
Clinical Trials Management LLC
🇺🇸Boca Raton, Florida, United States
1st Allergy & Clinical Research Center
🇺🇸Centennial, Colorado, United States
Allergy & Asthma Center / South Florida ENT
🇺🇸Ft. Lauderdale, Florida, United States
Colorado Otolaryngology Associates
🇺🇸Colorado Springs, Colorado, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Nasal Sinus and Allergy Institute
🇺🇸Alpharetta, Georgia, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
Massachusetts General Hospital - Allergy Clinical Research
🇺🇸Boston, Massachusetts, United States
Northeast Georgia Research Center
🇺🇸Gainsville, Georgia, United States
Northside Ear, Nose & Throat
🇺🇸Roswell, Georgia, United States
Allergy & Sinus Center
🇺🇸Greenwood, Mississippi, United States
Shah Eye Ear Nose & Throat
🇺🇸Lawrenceville, New Jersey, United States
Center for Allergy and Asthma of Bronx and Westchester
🇺🇸Bronx, New York, United States
ENT Care
🇺🇸Somerville, New Jersey, United States
Wilmington Health Associates
🇺🇸Wilmington, North Carolina, United States
Weill Medical College-Department of Otorhinolaryngology
🇺🇸New York, New York, United States
University of Pittsburgh - The Eye and Ear Institute
🇺🇸Pittsburgh, Pennsylvania, United States
ADAC Research PA
🇺🇸Greenville, South Carolina, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
The Allergy, Asthma & Sinus Center
🇺🇸Knoxville, Tennessee, United States
Clinical Research Group of Montana
🇺🇸Bozeman, Montana, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States