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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00447837
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : March 17, 2008
Sponsor:
Information provided by:
Naryx Pharma

Tracking Information
First Submitted Date  ICMJE March 13, 2007
First Posted Date  ICMJE March 15, 2007
Last Update Posted Date March 17, 2008
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2007)
Change from baseline in TSSS during first week post-therapy [ Time Frame: 86 days ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Sinusitis
Intervention  ICMJE Drug: SPRC-AB01
90 mg/3 mL BID, 180 mg/3 mL bid, placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: SPRC-AB01
  • Experimental: 2
    Intervention: Drug: SPRC-AB01
  • Placebo Comparator: 3
    Intervention: Drug: SPRC-AB01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2008)
180
Original Enrollment  ICMJE
 (submitted: March 13, 2007)
200
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00447837
Other Study ID Numbers  ICMJE SPRC-AB01-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimberly Salgado/VP Product Development, Naryx Pharma
Study Sponsor  ICMJE Naryx Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Naryx Pharma
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP