[Clinical equivalence trial of UROCALUN miniaturized tablet in patients with upper urinary tract stone disease].
We performed a clinical trial on patients with upper urinary tract stone disease (renal stone disease) to prove the clinical equivalence as the target for removal of renal stones between the new formulation (miniaturized tablet) and the conventional formulation (capsule) of UROCALUN. The clinically effective rate of both formulations was the same at 70% (28 of 40 cases), and it was suggested that these two formulations possess the same clinical efficacy. Adverse drug reactions were observed in 10.0% (4 of 40 cases) with the tablet and 5.0% (2 of 40 cases) with the capsule. There were no significant differences between the two formulations in the incidence of adverse drug reactions, and there were no clinically significant safety problems. In the questionnaire survey for patients about medication compliance, we found that the patients felt the miniaturized tablets were much easier to swallow than the conventional formulation. In conclusion, it is suggested that the miniaturized tablet contributes to improve the medication compliance for patients and thus it is expected to improve the clinical efficacy.
Higashi
Yoshihito
Y
Department of Urology, Takeda General Hospital.
Yamada
Hitoshi
H
Kobori
Gou
G
Hirai
Shinji
S
Kawamura
Juichi
J
Okada
Yuusaku
Y
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002214:Capsules; D005260:Female; D006801:Humans; D007669:Kidney Calculi / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*; D013607:Tablets; D013810:Therapeutic Equivalency
D002214:Capsules; D010936:Plant Extracts; D013607:Tablets; C046368:urocalun