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

Information source: Naryx Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Sinusitis

Intervention: SPRC-AB01 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Naryx Pharma

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from baseline in TSSS during first week post-therapy

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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, Ft. 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

Center for Allergy and Asthma of Bronx and Westchester, Bronx, New York 10465, 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

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

Additional Information

Starting date: October 2006
Last updated: March 13, 2008

Page last updated: August 23, 2015

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