Status:
COMPLETED
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
Lead Sponsor:
Naryx Pharma
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
16+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00447837
Start Date
October 1 2006
End Date
January 1 2008
Last Update
March 17 2008
Active Locations (43)
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1
Clinical Research Consultants
Hoover, Alabama, United States, 35216
2
NEA Clinic
Jonesboro, Arkansas, United States, 72401
3
Central California Clinical Research
Fresno, California, United States, 93720
4
Allergy Research Foundation, Inc
Los Angeles, California, United States, 90025