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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Chronic Disease
Sinusitis
Disease Attributes
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 29, 2014