Medical Expulsive Therapy for Ureter Stone Using Naftopidil

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Dong-A ST Co., Ltd.
• Treatments: Analgesics; Naftopidil

Criteria

Inclusion Criteria:

• >= 20 years

• single 3 to 10 mm ureter stone (longest diameter)

Exclusion Criteria:

• Presence of multiple ureter stones

• Renal insufficiency (serum Cr > 1.4 mg/dL)

• Febrile urinary tract infections(fever > 38°C, evidence of urinary infection)

• pregnancy or breast feeding

• solitary kidney

• hypersensitivity to naftopidil

• current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks)

• moderate or severe cardiovascular or cerebrovascular disease

• hepatic dysfunction (>2 x normal upper limit)

• significant active medical illness which in the opinion of the investigator would preclude protocol treatment

• Genetic disorder such as Galactose intolerance, Lapp Lactase deficiency, Glucose-Galactose malabsorption