drugset / Trial / NCT01929044

Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain

NCT01929044 ↗

Phase 3 Completed 299 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.

Timeline

Start
2013-08
Primary completion
2015-02
Completion
2015-02

Outcome

Met primary endpoint

registry Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine); p <0.0001; Mean Difference (Final Values) -0.42 (95% CI -0.88 to 0.04) NCT01929044 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anisodamine Traditional medicine (herbal / TCM) 10 mg —
Subject Hyoscine butylbromide Unknown 20 mg Intramuscular

Indications