Efficacy of Buscopan® in Comparison With 654-II (Anisodam... | NCT01929044

NCT01929044

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Name	Type	Description	Arm Group Labels	Other Names
654-II (anisodamine)	Drug	10mg injection	654-II(anisodamine)
Buscopan® (hyoscine butylbromide)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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'.	Baseline and 20 minutes after the first injection

Secondary Outcomes

Measure	Description	Time Frame
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'.	Baseline and 10 minutes after the first injection

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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.
Patients must agree to cooperate with all trial evaluations and perform all required tasks.
Patients with acute gastric or intestinal spasm-like pain (without severe vomiting and surgical acute abdomen).
Male or female patients aged 18 to 70 years.
The pain intensity upon screening is at least point 6 on a 0-10 numerical rating scale (NRS).

Exclusion criteria:

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.
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
Pregnancy and/or lactation or planned pregnancy;
Known hypersensitivity to N-butylscopolammonium bromide
Alcohol, or drug abuse.
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.
Unwilling to or unable to complete the entire trial procedure according to the protocol.
In investigator's opinion, the patient is not proper for the trial.

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
202.848.86016 Boehringer Ingelheim Investigational Site		Baotou			China
202.848.86008 Boehringer Ingelheim Investigational Site

References Module

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No data is available for this block.

IPD Sharing Statement Module

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No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Buscopan® (Hyoscine Butylbromide)	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
FG001	654-II (Anisodamine)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Treated Set (TS): All randomised patients who received at least one dose of study medication constituted the treated set. One patient was randomized to 654-II but incorrectly treated with Buscopan® so in the disposition table and efficacy analysis, number of patients are 152 and 143 while for demographic and AE analysis, they are 153 and 142.

Arm/Group Information

ID	Title	Description
BG000	Buscopan® (Hyoscine Butylbromide)	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
BG001	654-II (Anisodamine)	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-4.09± 0.17 OG001-3.66± 0.18

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Restricted maximum likelihood (REML) -repeated measures approach	Mixed Models Analysis	Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.	<0.0001		Mean Difference (Final Values)	-0.42	Standard Error of the Mean	0.23	2-Sided	95	-0.88	0.04			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.	Yes

Secondary

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'.

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.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and 10 minutes after the first injection

ID	Title	Description
OG000	Buscopan® (Hyoscine Butylbromide)	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
OG001	654-II (Anisodamine)	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

Units	Counts
Participants

Secondary

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'.

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.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and 30 minutes after the first injection

ID	Title	Description
OG000	Buscopan® (Hyoscine Butylbromide)	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
OG001	654-II (Anisodamine)	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

Units	Counts
Participants

Secondary

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'.

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.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and 60 minutes after the first injection

ID	Title	Description
OG000	Buscopan® (Hyoscine Butylbromide)	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
OG001	654-II (Anisodamine)	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

Units	Counts
Participants

Secondary

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'.

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.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline and 120 minutes after the first injection

ID	Title	Description
OG000	Buscopan® (Hyoscine Butylbromide)	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
OG001	654-II (Anisodamine)	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

Units	Counts
Participants

Secondary

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).

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.

Posted

Number

Percentage of Patients

120 minutes after the first injection

ID	Title	Description
OG000	Buscopan® (Hyoscine Butylbromide)	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
OG001	654-II (Anisodamine)	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

Units	Counts

Secondary

Proportion of Patients Who Need the Second Injection

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

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.

Posted

Number

95% Confidence Interval

Percentage of Patients

20 minutes after the first injection.

ID	Title	Description
OG000	Buscopan® (Hyoscine Butylbromide)	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
OG001	654-II (Anisodamine)	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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Buscopan® (Hyoscine Butylbromide)	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			1	153	12	153
EG001	654-II (Anisodamine)	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			0	142	10	142

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hernial eventration	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected153 at risk EG0010 affected142 at risk
Ileus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected153 at risk EG0010 affected142 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Thirst	General disorders	MedDRA 18.0	Systematic Assessment		EG00012 affected153 at risk EG00110 affected142 at risk

ID	Term
D007410	Intestinal Diseases

ID	Term
C003922	anisodamine
D002086	Butylscopolammonium Bromide

Ancestor Terms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds
D000470	Alkaloids
D006571	Heterocyclic Compounds
D019086	Bridged Bicyclo Compounds, Heterocyclic
D006572	Heterocyclic Compounds, Bridged-Ring

Non-Inferiority or Equivalence

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases