A Phase 4 clinical trial of EMPYNASE P tablets 18000 in patients with chronic sinusitis

Phase 4

• Conditions: chronic sinusitis

• Registration Number: JPRN-UMIN000008633
• Lead Sponsor: KAKEN PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-06
• Study Completion: 2014-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

-Patients with nasal polyp of score 2 or 3 -Patients diagnosed as eosinophilic sinusitis by the principal investigator or sub-investigator -Patients with complication such as maxillary sinusitis of dental origin, caseous maxillary sinusitis, sinus syst or asthma including aspirin-induced asthma -Patients with symptoms of acute sinusitis or acute exacerbation -Patients with pollinosis ( seasonal allergic rhinitis ), and term of causative pollen dispersal -Patients who have or are suspected to have sinus mycosis -Patients who have undergone operation of maxillary sinus, endoscopic sinus surgery or nasal polyplectomy, however patients underwent nasal polyplectomy before 3 months or more are excepted -Patients treated with the prohibited medication or therapy within 2 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Change in total score of both nasal sides based on scoring of disease state in maxillary sinuses by conventional radiography

Secondary Outcome Measures

Name	Time	Method
-Change in total score of both nasal sides based on scoring of objective opinion on nasal cavity -Change of score based on scoring of subjective nasal symptom