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

Phase 2

Completed

• Conditions: Chronic Sinusitis
• Interventions: Drug: SPRC-AB01

• 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

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-15
• Status Verified: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Last Update Submitted: 2008-03-13
• Last Update Posted: 2008-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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 Criteria

• 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

Trial Locations

Locations (43)

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

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