Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Sinusitis

In brief

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.

Key facts

Study ID

NCT00447837

Run by

Naryx Pharma

People needed

180

Starts

2006-10-01

Expected to finish

2008-01-01

Last updated by the study team

2008-03-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Consultants — Hoover, Alabama, United States
• NEA Clinic — Jonesboro, Arkansas, United States
• Central California Clinical Research — Fresno, California, United States
• Allergy Research Foundation, Inc — Los Angeles, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Allergy Medical Group of the North Area Inc — Roseville, California, United States
• Sacramento Ear, Nose & Throat — Sacramento, California, United States
• Allergy & Asthma Medical Group and Research Center — San Diego, California, United States
• 1st Allergy & Clinical Research Center — Centennial, Colorado, United States
• Colorado Otolaryngology Associates — Colorado Springs, Colorado, United States
• The Connecticut Sinus Center — Bridgeport, Connecticut, United States
• Clinical Trials Management LLC — Boca Raton, Florida, United States
• Allergy & Asthma Center / South Florida ENT — Fort Lauderdale, Florida, United States
• Clinical Research of West Florida — Tampa, Florida, United States
• Nasal Sinus and Allergy Institute — Alpharetta, Georgia, United States
• Northeast Georgia Research Center — Gainsville, Georgia, United States
• Northside Ear, Nose & Throat — Roswell, Georgia, United States
• Commonwealth Ear, Nose & Throat — Louisville, Kentucky, United States
• Calvert Internal Medicine Group — Prince Frederick, Maryland, United States
• Massachusetts General Hospital - Allergy Clinical Research — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• Allergy & Sinus Center — Greenwood, Mississippi, United States
• Clinical Research Group of Montana — Bozeman, Montana, United States
• Shah Eye Ear Nose & Throat — Lawrenceville, New Jersey, United States

Full record on ClinicalTrials.gov

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