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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
299
10mg injection
20mg injection
202.848.86016 Boehringer Ingelheim Investigational Site
Baotou, China
PID From Pre-dose Baseline at 20 Minutes After First Injection.
Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.
Time frame: Baseline and 20 minutes after the first injection
PID From Pre-dose Baseline at 10 Minutes After First Injection.
Pain intensity difference (PID) from pre-dose baseline at 10 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.
Time frame: Baseline and 10 minutes after the first injection
PID From Pre-dose Baseline at 30 Minutes After First Injection.
Pain intensity difference (PID) from pre-dose baseline at 30 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.
Time frame: Baseline and 30 minutes after the first injection
PID From Pre-dose Baseline at 60 Minutes After First Injection.
Pain intensity difference (PID) from pre-dose baseline at 60 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.
Time frame: Baseline and 60 minutes after the first injection
PID From Pre-dose Baseline at 120 Minutes After First Injection.
Pain intensity difference (PID) from pre-dose baseline at 120 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.
Time frame: Baseline and 120 minutes after the first injection
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202.848.86008 Boehringer Ingelheim Investigational Site
Beijing, China
202.848.86009 Boehringer Ingelheim Investigational Site
Beijing, China
202.848.86010 Boehringer Ingelheim Investigational Site
Beijing, China
202.848.86013 Boehringer Ingelheim Investigational Site
Beijing, China
202.848.86012 Boehringer Ingelheim Investigational Site
Changchun, China
202.848.86020 Boehringer Ingelheim Investigational Site
Changsha, China
202.848.86018 Boehringer Ingelheim Investigational Site
Chenzhou, China
202.848.86007 Boehringer Ingelheim Investigational Site
Chongqing, China
202.848.86021 Boehringer Ingelheim Investigational Site
Chongqing, China
...and 10 more locations
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Global assessment of efficacy by the patient. The patient was to assess the efficacy at 120 min after the first injection using a 4-point rating scale by answering the question: "How would you rate the effect of the study medication for relieving your acute gastric or intestinal spasm-like pain?" (0 = poor; 1 = fair; 2 = good; 3 = very good).
Time frame: 120 minutes after the first injection
Proportion of Patients Who Need the Second Injection
Proportion of patients who need the second injection at 20 minutes after the first injection.
Time frame: 20 minutes after the first injection.