Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis - Full Text View

Sponsored by:	Naryx Pharma
Information provided by:	Naryx Pharma
ClinicalTrials.gov Identifier:	NCT00447837

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 II

MedlinePlus related topics: Sinusitis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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

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

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

Keywords provided by Naryx Pharma:

Chronic Sinusitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Tobramycin
Respiratory Tract Infections

Respiratory Tract Diseases
Chronic Disease
Sinusitis

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009