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CompletedNCT01929044Updated Mar 8, 2016Results posted

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

A Phase 3 interventional study of 654-II (anisodamine) and Buscopan® (hyoscine butylbromide) in Intestinal Diseases, sponsored by Boehringer Ingelheim. Completed at 20 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-03-08.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
299
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal Diseases

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03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 299 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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.

  2. 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
  3. Pregnancy and/or lactation or planned pregnancy;
  4. Known hypersensitivity to N-butylscopolammonium bromide
  5. Alcohol, or drug abuse.
  6. 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.
  7. Unwilling to or unable to complete the entire trial procedure according to the protocol.
  8. In investigator's opinion, the patient is not proper for the trial.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
299 participants (actual)

Study arms

  • Experimental
    Buscopan® (hyoscine butylbromide)

    1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection

    Drug: Buscopan® (hyoscine butylbromide)

  • 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)

Interventions

  • Drug654-II (anisodamine)

    10mg injection

  • DrugBuscopan® (hyoscine butylbromide)

    20mg injection

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

07

Results

Posted Mar 8, 2016

Participant flow

299 patients were entered and 295 were treated.

Participant flow — Overall Study
MilestoneBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
Started153146
Completed142129
Not completed1117
Withdrew: Adverse event10
Withdrew: Protocol violation914
Withdrew: Not treated13

Outcome measures

PrimaryPID 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
Reported as:
Least squares mean · Units on a scale
PID From Pre-dose Baseline at 20 Minutes After First Injection.
Units on a scaleBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
PID From Pre-dose Baseline at 20 Minutes After First Injection.-4.09 ± 0.17-3.66 ± 0.18
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.42 · 95% CI -0.88 to 0.04REML-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.
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Mixed Models Analysis · p = 0.0743 · Mean difference (final values): -0.42 · 95% CI -0.88 to 0.04REML-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.
SecondaryPID 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
Reported as:
Least squares mean · Units on a scale
PID From Pre-dose Baseline at 10 Minutes After First Injection.
Units on a scaleBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
PID From Pre-dose Baseline at 10 Minutes After First Injection.-2.64 ± 0.14-2.33 ± 0.15
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Mixed Models Analysis · p = 0.1210 · Mean difference (final values): -0.31 · 95% CI -0.70 to 0.08REML-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.
SecondaryPID 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
Reported as:
Least squares mean · Units on a scale
PID From Pre-dose Baseline at 30 Minutes After First Injection.
Units on a scaleBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
PID From Pre-dose Baseline at 30 Minutes After First Injection.-5.14 ± 0.15-4.74 ± 0.16
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Mixed Models Analysis · p = 0.0658 · Mean difference (final values): -0.40 · 95% CI -0.82 to 0.03REML-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.
SecondaryPID 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
Reported as:
Least squares mean · Units on a scale
PID From Pre-dose Baseline at 60 Minutes After First Injection.
Units on a scaleBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
PID From Pre-dose Baseline at 60 Minutes After First Injection.-5.96 ± 0.14-5.51 ± 0.15
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Mixed Models Analysis · p = 0.0220 · Mean difference (final values): -0.46 · 95% CI -0.85 to -0.07REML-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.
SecondaryPID 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
Reported as:
Least squares mean · Units on a scale
PID From Pre-dose Baseline at 120 Minutes After First Injection.
Units on a scaleBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
PID From Pre-dose Baseline at 120 Minutes After First Injection.-6.46 ± 0.13-6.01 ± 0.14
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Mixed Models Analysis · p = 0.0149 · Mean difference (final values): -0.45 · 95% CI -0.81 to -0.09REML-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.
SecondaryGlobal 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
Reported as:
Number · Percentage of Patients
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Percentage of PatientsBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
Very Good22.522.0
Good59.244.1
Fair18.329.1
Poor0.04.7
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · van Elteren test · p = 0.0113The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.
SecondaryProportion 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.
Reported as:
Number · Percentage of Patients
Proportion of Patients Who Need the Second Injection
Percentage of PatientsBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
Proportion of Patients Who Need the Second Injection24.6 (17.81 to 32.58)33.9 (25.70 to 42.79)
Statistical analysis
  • Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine) · Regression, Logistic · p = 0.0992 · Odds ratio (or): 0.64 · 95% CI 0.37 to 1.09Exact 95% confidence interval obtained by Clopper and Pearson approach.

Adverse events

Collected over From first study drug application until 2 days (inclusive) after the last study drug application. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Buscopan® (Hyoscine Butylbromide)—1/153 (0.7%)12/153 (7.8%)
654-II (Anisodamine)—0/142 (0%)10/142 (7%)
Most frequent serious events
Most frequent serious events
EventBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
Hernial eventrationGastrointestinal disorders1/1530/142
IleusGastrointestinal disorders1/1530/142
Most frequent other events
Most frequent other events
EventBuscopan® (Hyoscine Butylbromide)654-II (Anisodamine)
ThirstGeneral disorders12/15310/142

Baseline characteristics

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.

Age, Continuous
Age, Continuous(Years)Buscopan® (Hyoscine Butylbromide)654-II (Anisodamine)Total
Mean41.5 ± 14.240.7 ± 14.841.1 ± 14.4
Sex: Female, Male
Sex: Female, Male(Participants)Buscopan® (Hyoscine Butylbromide)654-II (Anisodamine)Total
Female9076166
Male6366129
08

Study locations

20 sites
  • 202.848.86016 Boehringer Ingelheim Investigational Site
    Baotou, China
  • 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
  • 202.848.86006 Boehringer Ingelheim Investigational Site
    Guangzhou, China
  • 202.848.86003 Boehringer Ingelheim Investigational Site
    Hangzhou, China
  • 202.848.86022 Boehringer Ingelheim Investigational Site
    Huanggang, China
  • 202.848.86001 Boehringer Ingelheim Investigational Site
    Shanghai, China
  • 202.848.86011 Boehringer Ingelheim Investigational Site
    Shanghai, China
  • 202.848.86015 Boehringer Ingelheim Investigational Site
    Shenyang, China
  • 202.848.86014 Boehringer Ingelheim Investigational Site
    Shijiazhuang, China
  • 202.848.86019 Boehringer Ingelheim Investigational Site
    Wenzhou, China
  • 202.848.86004 Boehringer Ingelheim Investigational Site
    Wuhan, China
  • 202.848.86005 Boehringer Ingelheim Investigational Site
    Wuhan, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01929044
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 27, 2013
Start date
Aug 2013
Primary completion
Feb 2015
Completion
Feb 2015
Results posted
Mar 8, 2016
Last update
Mar 8, 2016

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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