[Clinical phase III study of cimetropium bromide (DA3177) on the pain with upper
urinary calculus: a double-blind study in comparison with scopolamine
butylbromide. DA3177 Study Group]. [Article in Japanese]
Author(s): Ohkawa T, Morimoto S, Okuyama A, Yoshioka T, Kishimoto T, Kurita T, Ikoma F,
Itatani H, Koide T, Ogawa N.
Affiliation(s): Department of Urology, Wakayama Medical College.
Publication date & source: 1997, Hinyokika Kiyo. , 43(7):525-38
A double-blind study was conducted to evaluate the efficacy, safety and
usefulness of cimetropium bromide (DA3177) in the patients with pain caused by
upper urinary calculus at a daily dose of 75 mg t.i.d. (Group D, 97 patients) in
comparison with scopolamine butylbromide at a daily dose of 60 mg t.i.d. (Group
B, 101 patients). According to patient's impression, the rate of "moderately
improved" or better was significantly higher in Group D (68.7%) than in Group B
(53.5%; Wilcoxon 2 sample test: p = 0.0044). For pain, the rate of "moderately
improved" or better was 69.1% in Group D and 60.4% in Group B. In global
improvement, the rate of "moderately improved" or better was significantly higher
in Group D (70.1%) than in Group B (61.4%; Wilcoxon 2 sample test: p = 0.0469).
The rate of "no problem in safety" showed no significant difference between Group
D (91.5%) and Group B (93.3%). Adverse reactions occurred in 8.5% in Group D and
6.7% in Group B. The major adverse reactions were "dry mouth", "abdominal
distension", "constipation" and "nausea". The rate of "useful" or better was
68.7% in Group D, and 60.4% in Group B. In conclusion, DA3177 was confirmed to be
a useful drug for patient with pain caused by upper urinary calculus.
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