drugset / Trial / NCT02106793

Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis

NCT02106793

Phase 3 Completed 224 enrolled Mahidol University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Primary objective * To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery * To validate the Thai version of disease-specific quality of life tool SNOT-22 Secondary objectives * To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo * To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo * To compare the side effects of Mitomicin C versus placebo

Timeline

Start
2015-03
Primary completion
2017-12-01
Completion
2017-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Mitomycin C Other / unclassified 0.4 mg/ml Intranasal