NCT01929044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 8, 2016

Completed
Last Updated

March 8, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

August 22, 2013

Results QC Date

February 10, 2016

Last Update Submit

February 10, 2016

Conditions

Intestinal Diseases

Outcome Measures

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'.

    Baseline and 20 minutes after the first injection

Secondary Outcomes (6)

  • PID From Pre-dose Baseline at 10 Minutes After First Injection.

    Baseline and 10 minutes after the first injection

  • PID From Pre-dose Baseline at 30 Minutes After First Injection.

    Baseline and 30 minutes after the first injection

  • PID From Pre-dose Baseline at 60 Minutes After First Injection.

    Baseline and 60 minutes after the first injection

  • PID From Pre-dose Baseline at 120 Minutes After First Injection.

    Baseline and 120 minutes after the first injection

  • Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection

    120 minutes after the first injection

  • +1 more secondary outcomes

Study Arms (2)

Buscopan® (hyoscine butylbromide)

EXPERIMENTAL

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

Drug: Buscopan® (hyoscine butylbromide)

654-II(anisodamine)

ACTIVE COMPARATOR

1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection

Drug: 654-II (anisodamine)

Interventions

654-II (anisodamine)DRUG

10mg injection

654-II(anisodamine)
Buscopan® (hyoscine butylbromide)DRUG

20mg injection

Buscopan® (hyoscine butylbromide)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Patients must agree to cooperate with all trial evaluations and perform all required tasks.
  • Patients with acute gastric or intestinal spasm-like pain (without severe vomiting and surgical acute abdomen).
  • Male or female patients aged 18 to 70 years.
  • The pain intensity upon screening is at least point 6 on a 0-10 numerical rating scale (NRS).

You may not qualify if:

  • 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.
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

202.848.86016 Boehringer Ingelheim Investigational Site

Baotou, China

Location

202.848.86008 Boehringer Ingelheim Investigational Site

Beijing, China

Location

202.848.86009 Boehringer Ingelheim Investigational Site

Beijing, China

Location

202.848.86010 Boehringer Ingelheim Investigational Site

Beijing, China

Location

202.848.86013 Boehringer Ingelheim Investigational Site

Beijing, China

Location

202.848.86012 Boehringer Ingelheim Investigational Site

Changchun, China

Location

202.848.86020 Boehringer Ingelheim Investigational Site

Changsha, China

Location

202.848.86018 Boehringer Ingelheim Investigational Site

Chenzhou, China

Location

202.848.86007 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

202.848.86021 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

202.848.86006 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

202.848.86003 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

202.848.86022 Boehringer Ingelheim Investigational Site

Huanggang, China

Location

202.848.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

202.848.86011 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

202.848.86015 Boehringer Ingelheim Investigational Site

Shenyang, China

Location

202.848.86014 Boehringer Ingelheim Investigational Site

Shijiazhuang, China

Location

202.848.86019 Boehringer Ingelheim Investigational Site

Wenzhou, China

Location

202.848.86004 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

202.848.86005 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

MeSH Terms

Conditions

Intestinal Diseases

Interventions

anisodamineButylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 27, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 8, 2016

Results First Posted

March 8, 2016

Record last verified: 2016-01

Locations

CN(20)