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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01929044
• Collaborator: (none)
• Enrollment: 299
• Locations: 20
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 15
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Diseases	Drug: 654-II (anisodamine); Drug: Buscopan® (hyoscine butylbromide)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 299 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Independent 3rd Party Unblind, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Anisodamine (654-II), 10mg, to Evaluate the Efficacy and Safety of Buscopan® Solution for Injection, 20mg (Intramuscularly) for the Treatment of Acute Gastric or Intestinal Spasm-like Pain
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buscopan® (hyoscine butylbromide) 1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection	Drug: Buscopan® (hyoscine butylbromide); 20mg injection
Active Comparator: 654-II(anisodamine) 1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection	Drug: 654-II (anisodamine); 10mg injection

Outcome Measures

Primary Outcome Measures

1. PID From Pre-dose Baseline at 20 Minutes After First Injection. [Baseline and 20 minutes after the 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'.

Secondary Outcome Measures

1. PID From Pre-dose Baseline at 10 Minutes After First Injection. [Baseline and 10 minutes after the 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'.

2. PID From Pre-dose Baseline at 30 Minutes After First Injection. [Baseline and 30 minutes after the 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'.

3. PID From Pre-dose Baseline at 60 Minutes After First Injection. [Baseline and 60 minutes after the 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'.

4. PID From Pre-dose Baseline at 120 Minutes After First Injection. [Baseline and 120 minutes after the 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'.

5. Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection [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).

6. Proportion of Patients Who Need the Second Injection [20 minutes after the first injection.]

   Proportion of patients who need the second injection at 20 minutes after the first injection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and local regulation prior to participation in the trial.

2. Patients must agree to cooperate with all trial evaluations and perform all required tasks.

3. Patients with acute gastric or intestinal spasm-like pain (without severe vomiting and surgical acute abdomen).

4. Male or female patients aged 18 to 70 years.

5. The pain intensity upon screening is at least point 6 on a 0-10 numerical rating scale (NRS).

Exclusion criteria:

1. Patients with the following concomitant disease is not eligible for enrollment:

• Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastrointestinal perforation, suspected gastrointestinal perforation or peritoneal effusion.

• Pain related with malignancy.

• Patients with other severe pain states of organic origin.

• Mechanical stenosis of the gastrointestinal tract ,megacolin.

• Urinary retention associated with mechanical stenosis of urinary tract.

• Narrow-angled glaucoma.

• Tachyarrhythmia.

• Myasthenia gravis.

• Meulengracht-Gilbert syndrome.

• Known depression or known mental illness, anxiety disturbance.

1. Patients taking the following concomitant medication within 7 half-life of concomitant medication (the duration from taking concomitant medication to attending the trial is less than 7 half-life) are not eligible for enrollment:

• Analgesics,

• Spasmolytics,

• Anticholinergics

• Affecting gastrointestinal motility, such as propantheline, metoclopramide, cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer treatment

• Regular administration of laxatives

• Narcotics

• Antidepressant treatment or treatment with psychoactive drugs

1. Pregnancy and/or lactation or planned pregnancy;

2. Known hypersensitivity to N-butylscopolammonium bromide

3. Alcohol, or drug abuse.

4. Simultaneous participating in another clinical trial, or discontinuing from another clinical trial before randomization (administration of study medication); moreover, in the case of screening failure or premature discontinuing from the trial, repeated enrollment is forbidden.

5. Unwilling to or unable to complete the entire trial procedure according to the protocol.

6. In investigator's opinion, the patient is not proper for the trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	202.848.86016 Boehringer Ingelheim Investigational Site	Baotou		China
2	202.848.86008 Boehringer Ingelheim Investigational Site	Beijing		China
3	202.848.86009 Boehringer Ingelheim Investigational Site	Beijing		China
4	202.848.86010 Boehringer Ingelheim Investigational Site	Beijing		China
5	202.848.86013 Boehringer Ingelheim Investigational Site	Beijing		China
6	202.848.86012 Boehringer Ingelheim Investigational Site	Changchun		China
7	202.848.86020 Boehringer Ingelheim Investigational Site	Changsha		China
8	202.848.86018 Boehringer Ingelheim Investigational Site	Chenzhou		China
9	202.848.86007 Boehringer Ingelheim Investigational Site	Chongqing		China
10	202.848.86021 Boehringer Ingelheim Investigational Site	Chongqing		China
11	202.848.86006 Boehringer Ingelheim Investigational Site	Guangzhou		China
12	202.848.86003 Boehringer Ingelheim Investigational Site	Hangzhou		China
13	202.848.86022 Boehringer Ingelheim Investigational Site	Huanggang		China
14	202.848.86001 Boehringer Ingelheim Investigational Site	Shanghai		China
15	202.848.86011 Boehringer Ingelheim Investigational Site	Shanghai		China
16	202.848.86015 Boehringer Ingelheim Investigational Site	Shenyang		China
17	202.848.86014 Boehringer Ingelheim Investigational Site	Shijiazhuang		China
18	202.848.86019 Boehringer Ingelheim Investigational Site	Wenzhou		China
19	202.848.86004 Boehringer Ingelheim Investigational Site	Wuhan		China
20	202.848.86005 Boehringer Ingelheim Investigational Site	Wuhan		China

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01929044
• Other Study ID Numbers: 202.848
• First Posted: Aug 27, 2013
• Last Update Posted: Mar 8, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Intestinal Diseases; Anisodamine; Scopolamine; Butylscopolammonium Bromide

Study Results

Participant Flow

Recruitment Details	299 patients were entered and 295 were treated.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Period Title: Overall Study
STARTED	153	146
COMPLETED	142	129
NOT COMPLETED	11	17

Baseline Characteristics

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)	Total
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients	Total of all reporting groups
Overall Participants	153	142	295
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	41.5 (14.2)	40.7 (14.8)	41.1 (14.4)
Sex: Female, Male (Count of Participants)
Female	90 58.8%	76 53.5%	166 56.3%
Male	63 41.2%	66 46.5%	129 43.7%

Outcome Measures

1. Primary Outcome

Title	PID From Pre-dose Baseline at 20 Minutes After First Injection.
Description	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

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS: all patients who provided any data for the primary efficacy endpoint constituted the full analysis set.), who revealed no important protocol violations that would impact the analysis of primary endpoint

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Least Squares Mean (Standard Error) [Units on a scale]	-4.09 (0.17)	-3.66 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments	Restricted maximum likelihood (REML) -repeated measures approach
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	One-sided test relative to the non-inferiority margin of 1
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -0.88 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments	REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0743
	Comments
	Method	Mixed Models Analysis
	Comments	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) 95%; -0.88 to 0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments	REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.

2. Secondary Outcome

Title	PID From Pre-dose Baseline at 10 Minutes After First Injection.
Description	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

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Least Squares Mean (Standard Error) [Units on a scale]	-2.64 (0.14)	-2.33 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1210
	Comments
	Method	Mixed Models Analysis
	Comments	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments	REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.

3. Secondary Outcome

Title	PID From Pre-dose Baseline at 30 Minutes After First Injection.
Description	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

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Least Squares Mean (Standard Error) [Units on a scale]	-5.14 (0.15)	-4.74 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0658
	Comments
	Method	Mixed Models Analysis
	Comments	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.40
	Confidence Interval	(2-Sided) 95%; -0.82 to 0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments	REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.

4. Secondary Outcome

Title	PID From Pre-dose Baseline at 60 Minutes After First Injection.
Description	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

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Least Squares Mean (Standard Error) [Units on a scale]	-5.96 (0.14)	-5.51 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0220
	Comments
	Method	Mixed Models Analysis
	Comments	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95%; -0.85 to -0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.20
	Estimation Comments	REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.

5. Secondary Outcome

Title	PID From Pre-dose Baseline at 120 Minutes After First Injection.
Description	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

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Least Squares Mean (Standard Error) [Units on a scale]	-6.46 (0.13)	-6.01 (0.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0149
	Comments
	Method	Mixed Models Analysis
	Comments	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -0.81 to -0.09
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments	REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.

6. Secondary Outcome

Title	Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Description	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

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Very Good	22.5	22.0
Good	59.2	44.1
Fair	18.3	29.1
Poor	0.0	4.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0113
	Comments
	Method	van Elteren test
	Comments	The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.

7. Secondary Outcome

Title	Proportion of Patients Who Need the Second Injection
Description	Proportion of patients who need the second injection at 20 minutes after the first injection.
Time Frame	20 minutes after the first injection.

Outcome Measure Data

Analysis Population Description

Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.

Arm/Group Title	Buscopan® (Hyoscine Butylbromide)	654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients	Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
Measure Participants	142	127
Number (95% Confidence Interval) [Percentage of Patients]	24.6	33.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Buscopan® (Hyoscine Butylbromide), 654-II (Anisodamine)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0992
	Comments
	Method	Regression, Logistic
	Comments	A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.37 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Exact 95% confidence interval obtained by Clopper and Pearson approach.

Adverse Events

Time Frame	From first study drug application until 2 days (inclusive) after the last study drug application
Arm/Group Title	Buscopan® (Hyoscine Butylbromide)		654-II (Anisodamine)
Arm/Group Description	Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients		Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
All Cause Mortality
	Buscopan® (Hyoscine Butylbromide)		654-II (Anisodamine)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Buscopan® (Hyoscine Butylbromide)		654-II (Anisodamine)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/153 (0.7%)		0/142 (0%)
Gastrointestinal disorders
Hernial eventration	1/153 (0.7%)		0/142 (0%)
Ileus	1/153 (0.7%)		0/142 (0%)
Other (Not Including Serious) Adverse Events
	Buscopan® (Hyoscine Butylbromide)		654-II (Anisodamine)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/153 (7.8%)		10/142 (7%)
General disorders
Thirst	12/153 (7.8%)		10/142 (7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.