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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SPRC-AB01
Sponsored by
Naryx Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring Chronic Sinusitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Research Consultants
  • NEA Clinic
  • Central California Clinical Research
  • Allergy Research Foundation, Inc
  • Children's Hospital of Orange County
  • Allergy Medical Group of the North Area Inc
  • Sacramento Ear, Nose & Throat
  • Allergy & Asthma Medical Group and Research Center
  • 1st Allergy & Clinical Research Center
  • Colorado Otolaryngology Associates
  • The Connecticut Sinus Center
  • Clinical Trials Management LLC
  • Allergy & Asthma Center / South Florida ENT
  • Clinical Research of West Florida
  • Nasal Sinus and Allergy Institute
  • Northeast Georgia Research Center
  • Northside Ear, Nose & Throat
  • Commonwealth Ear, Nose & Throat
  • Calvert Internal Medicine Group
  • Massachusetts General Hospital - Allergy Clinical Research
  • Henry Ford Health System
  • Clinical Research Institute
  • Allergy & Sinus Center
  • Clinical Research Group of Montana
  • Shah Eye Ear Nose & Throat
  • ENT Care
  • Center for Allergy and Asthma of Bronx and Westchester
  • Weill Medical College-Department of Otorhinolaryngology
  • University of Rochester-Otolaryngology Associates
  • Charlotte Eye, Ear, Nose & Throat Associates
  • Wilmington Health Associates
  • Cleveland Clinic - Head & Neck Institute
  • Toledo Center for Clinical Research
  • University of Pittsburgh - The Eye and Ear Institute
  • ADAC Research PA
  • The Jackson Clinic
  • The Allergy, Asthma & Sinus Center
  • Ear, Nose & Throat Associates of Corpus Christi / Research
  • Allergy and Asthma Associates
  • Research Across America
  • San Antonio Ear, Nose and Throat Research
  • Marshfield Clinic
  • Marshfield Clinic - Weston Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in TSSS during first week post-therapy

Secondary Outcome Measures

Full Information

First Posted
March 13, 2007
Last Updated
March 13, 2008
Sponsor
Naryx Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00447837
Brief Title
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Naryx Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPRC-AB01
Intervention Description
90 mg/3 mL BID, 180 mg/3 mL bid, placebo
Primary Outcome Measure Information:
Title
Change from baseline in TSSS during first week post-therapy
Time Frame
86 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Clinical Research Consultants
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Central California Clinical Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Allergy Research Foundation, Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Allergy Medical Group of the North Area Inc
City
Roseville
State/Province
California
ZIP/Postal Code
95678
Country
United States
Facility Name
Sacramento Ear, Nose & Throat
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Allergy & Asthma Medical Group and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
1st Allergy & Clinical Research Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Otolaryngology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
The Connecticut Sinus Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Clinical Trials Management LLC
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Allergy & Asthma Center / South Florida ENT
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Nasal Sinus and Allergy Institute
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30004
Country
United States
Facility Name
Northeast Georgia Research Center
City
Gainsville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northside Ear, Nose & Throat
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Commonwealth Ear, Nose & Throat
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Calvert Internal Medicine Group
City
Prince Frederick
State/Province
Maryland
ZIP/Postal Code
20678
Country
United States
Facility Name
Massachusetts General Hospital - Allergy Clinical Research
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Allergy & Sinus Center
City
Greenwood
State/Province
Mississippi
ZIP/Postal Code
38930
Country
United States
Facility Name
Clinical Research Group of Montana
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Shah Eye Ear Nose & Throat
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
ENT Care
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Center for Allergy and Asthma of Bronx and Westchester
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Weill Medical College-Department of Otorhinolaryngology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester-Otolaryngology Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Wilmington Health Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Cleveland Clinic - Head & Neck Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
University of Pittsburgh - The Eye and Ear Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
ADAC Research PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
The Jackson Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
The Allergy, Asthma & Sinus Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Ear, Nose & Throat Associates of Corpus Christi / Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Allergy and Asthma Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Research Across America
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
San Antonio Ear, Nose and Throat Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Marshfield Clinic - Weston Center
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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