Trial Outcomes & Findings for Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain (NCT NCT01929044)
NCT ID: NCT01929044
Last Updated: 2016-03-08
Results Overview
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'.
COMPLETED
PHASE3
299 participants
Baseline and 20 minutes after the first injection
2016-03-08
Participant Flow
299 patients were entered and 295 were treated.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
146
|
|
Overall Study
COMPLETED
|
142
|
129
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
9
|
14
|
|
Overall Study
Not Treated
|
1
|
3
|
Baseline Characteristics
Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Baseline characteristics by cohort
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=153 Participants
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
|
654-II (Anisodamine)
n=142 Participants
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
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 Years
STANDARD_DEVIATION 14.2 • n=39 Participants
|
40.7 Years
STANDARD_DEVIATION 14.8 • n=41 Participants
|
41.1 Years
STANDARD_DEVIATION 14.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=39 Participants
|
76 Participants
n=41 Participants
|
166 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=39 Participants
|
66 Participants
n=41 Participants
|
129 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline and 20 minutes after the first injectionPopulation: 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
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'.
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
PID From Pre-dose Baseline at 20 Minutes After First Injection.
|
-4.09 Units on a scale
Standard Error 0.17
|
-3.66 Units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline and 10 minutes after the first injectionPopulation: 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.
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'.
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
PID From Pre-dose Baseline at 10 Minutes After First Injection.
|
-2.64 Units on a scale
Standard Error 0.14
|
-2.33 Units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and 30 minutes after the first injectionPopulation: 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.
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'.
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
PID From Pre-dose Baseline at 30 Minutes After First Injection.
|
-5.14 Units on a scale
Standard Error 0.15
|
-4.74 Units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and 60 minutes after the first injectionPopulation: 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.
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'.
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
PID From Pre-dose Baseline at 60 Minutes After First Injection.
|
-5.96 Units on a scale
Standard Error 0.14
|
-5.51 Units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline and 120 minutes after the first injectionPopulation: 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.
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'.
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
PID From Pre-dose Baseline at 120 Minutes After First Injection.
|
-6.46 Units on a scale
Standard Error 0.13
|
-6.01 Units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: 120 minutes after the first injectionPopulation: 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.
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).
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Very Good
|
22.5 Percentage of Patients
|
22.0 Percentage of Patients
|
|
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Good
|
59.2 Percentage of Patients
|
44.1 Percentage of Patients
|
|
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Fair
|
18.3 Percentage of Patients
|
29.1 Percentage of Patients
|
|
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Poor
|
0.0 Percentage of Patients
|
4.7 Percentage of Patients
|
SECONDARY outcome
Timeframe: 20 minutes after the first injection.Population: 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.
Proportion of patients who need the second injection at 20 minutes after the first injection.
Outcome measures
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=142 Participants
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
|
654-II (Anisodamine)
n=127 Participants
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
|
|---|---|---|
|
Proportion of Patients Who Need the Second Injection
|
24.6 Percentage of Patients
Interval 17.81 to 32.58
|
33.9 Percentage of Patients
Interval 25.7 to 42.79
|
Adverse Events
Buscopan® (Hyoscine Butylbromide)
654-II (Anisodamine)
Serious adverse events
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=153 participants at risk
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
|
654-II (Anisodamine)
n=142 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Hernial eventration
|
0.65%
1/153 • From first study drug application until 2 days (inclusive) after the last study drug application
|
0.00%
0/142 • From first study drug application until 2 days (inclusive) after the last study drug application
|
|
Gastrointestinal disorders
Ileus
|
0.65%
1/153 • From first study drug application until 2 days (inclusive) after the last study drug application
|
0.00%
0/142 • From first study drug application until 2 days (inclusive) after the last study drug application
|
Other adverse events
| Measure |
Buscopan® (Hyoscine Butylbromide)
n=153 participants at risk
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
|
654-II (Anisodamine)
n=142 participants at risk
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
|
|---|---|---|
|
General disorders
Thirst
|
7.8%
12/153 • From first study drug application until 2 days (inclusive) after the last study drug application
|
7.0%
10/142 • From first study drug application until 2 days (inclusive) after the last study drug application
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER