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

• 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: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: August 22, 2013
• First Posted Date: August 27, 2013
• Results First Submitted Date: February 10, 2016
• Results First Posted Date: March 8, 2016
• Last Update Posted Date: March 8, 2016
• Study Start Date: August 2013
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: August 22, 2013): Pain intensity difference (PID) from pre-dose baseline at 20 minutes after the first injection. [ Time Frame: baseline and 20min ]

Current Secondary Outcome Measures (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 (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: Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Intestinal Diseases

Intervention

• Drug: 654-II (anisodamine)
  10mg injection
• Drug: Buscopan® (hyoscine butylbromide)
  20mg injection

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 8, 2015): 299
• Original Estimated Enrollment (submitted: August 22, 2013): 296
• Actual Study Completion Date: February 2015
• Actual Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01929044
• Other Study ID Numbers: 202.848
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Boehringer Ingelheim
• Study Sponsor: Boehringer Ingelheim
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: January 2016