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

March 13, 2008 updated by: Naryx Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Clinic
    • California
      • Fresno, California, United States, 93720
        • Central California Clinical Research
      • Los Angeles, California, United States, 90025
        • Allergy Research Foundation, Inc
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Roseville, California, United States, 95678
        • Allergy Medical Group of the North Area Inc
      • Sacramento, California, United States, 95815
        • Sacramento Ear, Nose & Throat
      • San Diego, California, United States, 92123
        • Allergy & Asthma Medical Group and Research Center
    • Colorado
      • Centennial, Colorado, United States, 80112
        • 1st Allergy & Clinical Research Center
      • Colorado Springs, Colorado, United States, 80909
        • Colorado Otolaryngology Associates
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • The Connecticut Sinus Center
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Clinical Trials Management LLC
      • Ft. Lauderdale, Florida, United States, 33334
        • Allergy & Asthma Center / South Florida ENT
      • Tampa, Florida, United States, 33603
        • Clinical Research of West Florida
    • Georgia
      • Alpharetta, Georgia, United States, 30004
        • Nasal Sinus and Allergy Institute
      • Gainsville, Georgia, United States, 30501
        • Northeast Georgia Research Center
      • Roswell, Georgia, United States, 30076
        • Northside Ear, Nose & Throat
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Commonwealth Ear, Nose & Throat
    • Maryland
      • Prince Frederick, Maryland, United States, 20678
        • Calvert Internal Medicine Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Allergy Clinical Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Clinical Research Institute
    • Mississippi
      • Greenwood, Mississippi, United States, 38930
        • Allergy & Sinus Center
    • Montana
      • Bozeman, Montana, United States, 59718
        • Clinical Research Group of Montana
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Shah Eye Ear Nose & Throat
      • Somerville, New Jersey, United States, 08876
        • ENT Care
    • New York
      • Bronx, New York, United States, 10465
        • Center for Allergy and Asthma of Bronx and Westchester
      • New York, New York, United States, 10021
        • Weill Medical College-Department of Otorhinolaryngology
      • Rochester, New York, United States, 14618
        • University of Rochester-Otolaryngology Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Charlotte Eye, Ear, Nose & Throat Associates
      • Wilmington, North Carolina, United States, 28405
        • Wilmington Health Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Head & Neck Institute
      • Sylvania, Ohio, United States, 43560
        • Toledo Center for Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh - The Eye and Ear Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • ADAC Research PA
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic
      • Knoxville, Tennessee, United States, 37909
        • The Allergy, Asthma & Sinus Center
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Ear, Nose & Throat Associates of Corpus Christi / Research
      • Houston, Texas, United States, 77054
        • Allergy and Asthma Associates
      • Plano, Texas, United States, 75093
        • Research Across America
      • San Antonio, Texas, United States, 78229
        • San Antonio Ear, Nose and Throat Research
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Weston, Wisconsin, United States, 54476
        • Marshfield Clinic - Weston Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: SPRC-AB01
90 mg/3 mL BID, 180 mg/3 mL bid, placebo
Experimental: 2
Drug: SPRC-AB01
90 mg/3 mL BID, 180 mg/3 mL bid, placebo
Placebo Comparator: 3
Drug: SPRC-AB01
90 mg/3 mL BID, 180 mg/3 mL bid, placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in TSSS during first week post-therapy
Time Frame: 86 days
86 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naryx Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria

March 13, 2007

First Posted (Estimate)

March 15, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2008

Last Update Submitted That Met QC Criteria

March 13, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPRC-AB01-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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