Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC-AB01, Tobramycin Solution for Nasal Inhalation, in Post-Surgical Subjects With Chronic Sinusitis
1 other identifier
interventional
180
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 13, 2007
CompletedFirst Posted
Study publicly available on registry
March 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedMarch 17, 2008
December 1, 2007
1.2 years
March 13, 2007
March 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in TSSS during first week post-therapy
86 days
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naryx Pharmalead
Study Sites (43)
Clinical Research Consultants
Hoover, Alabama, 35216, United States
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Central California Clinical Research
Fresno, California, 93720, United States
Allergy Research Foundation, Inc
Los Angeles, California, 90025, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Allergy Medical Group of the North Area Inc
Roseville, California, 95678, United States
Sacramento Ear, Nose & Throat
Sacramento, California, 95815, United States
Allergy & Asthma Medical Group and Research Center
San Diego, California, 92123, United States
1st Allergy & Clinical Research Center
Centennial, Colorado, 80112, United States
Colorado Otolaryngology Associates
Colorado Springs, Colorado, 80909, United States
The Connecticut Sinus Center
Bridgeport, Connecticut, 06606, United States
Clinical Trials Management LLC
Boca Raton, Florida, 33487, United States
Allergy & Asthma Center / South Florida ENT
Fort Lauderdale, Florida, 33334, United States
Clinical Research of West Florida
Tampa, Florida, 33603, United States
Nasal Sinus and Allergy Institute
Alpharetta, Georgia, 30004, United States
Northeast Georgia Research Center
Gainsville, Georgia, 30501, United States
Northside Ear, Nose & Throat
Roswell, Georgia, 30076, United States
Commonwealth Ear, Nose & Throat
Louisville, Kentucky, 40207, United States
Calvert Internal Medicine Group
Prince Frederick, Maryland, 20678, United States
Massachusetts General Hospital - Allergy Clinical Research
Boston, Massachusetts, 02114, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
Allergy & Sinus Center
Greenwood, Mississippi, 38930, United States
Clinical Research Group of Montana
Bozeman, Montana, 59718, United States
Shah Eye Ear Nose & Throat
Lawrenceville, New Jersey, 08648, United States
ENT Care
Somerville, New Jersey, 08876, United States
Weill Medical College-Department of Otorhinolaryngology
New York, New York, 10021, United States
University of Rochester-Otolaryngology Associates
Rochester, New York, 14618, United States
Center for Allergy and Asthma of Bronx and Westchester
The Bronx, New York, 10465, United States
Charlotte Eye, Ear, Nose & Throat Associates
Charlotte, North Carolina, 28210, United States
Wilmington Health Associates
Wilmington, North Carolina, 28405, United States
Cleveland Clinic - Head & Neck Institute
Cleveland, Ohio, 44195, United States
Toledo Center for Clinical Research
Sylvania, Ohio, 43560, United States
University of Pittsburgh - The Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213, United States
ADAC Research PA
Greenville, South Carolina, 29607, United States
The Jackson Clinic
Jackson, Tennessee, 38301, United States
The Allergy, Asthma & Sinus Center
Knoxville, Tennessee, 37909, United States
Ear, Nose & Throat Associates of Corpus Christi / Research
Corpus Christi, Texas, 78411, United States
Allergy and Asthma Associates
Houston, Texas, 77054, United States
Research Across America
Plano, Texas, 75093, United States
San Antonio Ear, Nose and Throat Research
San Antonio, Texas, 78229, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 13, 2007
First Posted
March 15, 2007
Study Start
October 1, 2006
Primary Completion
December 1, 2007
Study Completion
January 1, 2008
Last Updated
March 17, 2008
Record last verified: 2007-12