Clinical equivalence trial of UROCALUN miniaturized tablet in patients with upper urinary tract stone disease

ウロカルンの新製剤である小型化錠と従来製剤(0号硬カプセル剤)との臨床的同等性試験を実施した.体外衝撃波結石破砕術後, 腹部超音波断層法により残石が確認された腎結石症例を対象とした.小型化錠群40例, カプセル群40例の2群に無作為に分けて, 腹部超音波断層法および腎尿管膀胱部単純X線撮影(KUB)を用いて, 排石効果の有効性, 安全性について評価した.治験薬投与期間は最大12週間とした.その結果, 両投与群とも有効率は70%であり, 完全排石率は小型化錠群で35%, カプセル群で42.5%であった.腹部超音波断層法では有効率の経時的な上昇を示し, 治験薬投与終了あるいは中止時におけるKUBでは両投与群とも有効率, 完全排石率が82.5%であった.副作用は, 下痢が各群に2例ずつ, 口渇1例, 肝機能異常1例を小型化錠群に認めた.服薬アンケート調査より, 小型化錠はカプセルと比較して小さく, 服用しやすいということが示唆された.ウロカルン小型化錠は従来製剤と同等の排石効果を有し, 安全性においても特に問題となる副作用は認めなかった
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.