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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008633

Enrollment

260

Registered

2012-08-06

Start date

2012-07-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic sinusitis

Interventions

EMPYNASE group EMPYNASE P Tablets are administrated orally after three meals for 12 weeks. Clarithromycin Tablets are administrated orally after breakfast for 14 weeks. Placebo group Placebo Ta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Written informed consent obtained from patients -Patients over 20 years old -Patients with symptoms which had persisted for more than or equal to 12 weeks, such as nasal congestion, rhinorrhea, postnasal drip and coughing -Patients with certain score of both sides based on scoring of disease state in maxillary sinuses by conventional radiography -Patients with certain score of both sides based on scoring of edema and swelling of nasal mucosa -Patients with certain score based on scoring of rhinorrhea or postnasal drip

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
-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	—

Countries

Japan

Contacts

Public ContactYoshitaka Urabe

KAKEN PHARMACEUTICAL CO., LTD. Clinical Development Department

urabe_yoshitaka@kaken.co.jp03-5977-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026