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

This study has been completed.
Sponsor:
Information provided by:
Naryx Pharma
ClinicalTrials.gov Identifier:
NCT00447837
First received: March 13, 2007
Last updated: March 13, 2008
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Chronic Sinusitis
Drug: SPRC-AB01
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Naryx Pharma:

Primary Outcome Measures:
  • Change from baseline in TSSS during first week post-therapy [ Time Frame: 86 days ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: October 2006
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447837

  Show 43 Study Locations
Sponsors and Collaborators
Naryx Pharma
  More Information

No publications provided

Responsible Party: Kimberly Salgado/VP Product Development, Naryx Pharma
ClinicalTrials.gov Identifier: NCT00447837     History of Changes
Other Study ID Numbers: SPRC-AB01-003
Study First Received: March 13, 2007
Last Updated: March 13, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Naryx Pharma:
Chronic Sinusitis

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014