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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intestinal Diseases Drug: 654-II (anisodamine) Drug: Buscopan® (hyoscine butylbromide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. 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'.

  2. 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'.

  3. 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'.

  4. 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'.

  5. 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).

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929044


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01929044    
Other Study ID Numbers: 202.848
First Posted: August 27, 2013    Key Record Dates
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anisodamine
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Anti-Arrhythmia Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents