NCT00447837

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Naryx Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DRUG	SPRC-AB01	90 mg/3 mL BID, 180 mg/3 mL bid, placebo

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-12-01
• Completion: 2008-01-01
• First posted: 2007-03-15
• Last updated: 2008-03-17

Locations

43 sites across 1 country: United States