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

February 10, 2016 updated by: Boehringer Ingelheim

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Baotou, China
        • 202.848.86016 Boehringer Ingelheim Investigational Site
      • Beijing, 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
      • Changchun, China
        • 202.848.86012 Boehringer Ingelheim Investigational Site
      • Changsha, China
        • 202.848.86020 Boehringer Ingelheim Investigational Site
      • Chenzhou, China
        • 202.848.86018 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 202.848.86007 Boehringer Ingelheim Investigational Site
      • Chongqing, China
        • 202.848.86021 Boehringer Ingelheim Investigational Site
      • Guangzhou, China
        • 202.848.86006 Boehringer Ingelheim Investigational Site
      • Hangzhou, China
        • 202.848.86003 Boehringer Ingelheim Investigational Site
      • Huanggang, China
        • 202.848.86022 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 202.848.86001 Boehringer Ingelheim Investigational Site
      • Shanghai, China
        • 202.848.86011 Boehringer Ingelheim Investigational Site
      • Shenyang, China
        • 202.848.86015 Boehringer Ingelheim Investigational Site
      • Shijiazhuang, China
        • 202.848.86014 Boehringer Ingelheim Investigational Site
      • Wenzhou, China
        • 202.848.86019 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 202.848.86004 Boehringer Ingelheim Investigational Site
      • Wuhan, China
        • 202.848.86005 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PID From Pre-dose Baseline at 20 Minutes After First Injection.
Time Frame: 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'.
Baseline and 20 minutes after the first injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PID From Pre-dose Baseline at 10 Minutes After First Injection.
Time Frame: 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'.
Baseline and 10 minutes after the first injection
PID From Pre-dose Baseline at 30 Minutes After First Injection.
Time Frame: 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'.
Baseline and 30 minutes after the first injection
PID From Pre-dose Baseline at 60 Minutes After First Injection.
Time Frame: 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'.
Baseline and 60 minutes after the first injection
PID From Pre-dose Baseline at 120 Minutes After First Injection.
Time Frame: 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'.
Baseline and 120 minutes after the first injection
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Time Frame: 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).
120 minutes after the first injection
Proportion of Patients Who Need the Second Injection
Time Frame: 20 minutes after the first injection.
Proportion of patients who need the second injection at 20 minutes after the first injection.
20 minutes after the first injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202.848

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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