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

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ClinicalTrials.gov Identifier: NCT01929044
Recruitment Status : Completed
First Posted : August 27, 2013
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 22, 2013
First Posted Date  ICMJE August 27, 2013
Results First Submitted Date  ICMJE February 10, 2016
Results First Posted Date  ICMJE March 8, 2016
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
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'.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
Pain intensity difference (PID) from pre-dose baseline at 20 minutes after the first injection. [ Time Frame: baseline and 20min ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • 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'.
  • 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'.
  • 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'.
  • 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'.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
  • PID from pre-dose baseline at 10, 30, 60 and 120 minutes after the first injection. [ Time Frame: up to 120min ]
  • Global assessment of efficacy by the patient at 120 minutes after the first injection using a 4-point rating scale (0=poor; 1=fair; 2=good; 3=very good). [ Time Frame: 120min ]
  • Proportion of patients who need the second injection at 20 minutes after the first injection. [ Time Frame: 20min ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Intestinal Diseases
Intervention  ICMJE
  • Drug: 654-II (anisodamine)
    10mg injection
  • Drug: Buscopan® (hyoscine butylbromide)
    20mg injection
Study Arms  ICMJE
  • Experimental: Buscopan® (hyoscine butylbromide)
    1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection
    Intervention: 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
    Intervention: Drug: 654-II (anisodamine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2015)
299
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2013)
296
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01929044
Other Study ID Numbers  ICMJE 202.848
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP