Intestinal DiseasesPhase 3NCT01929044

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

A Phase 3 study testing 654-II (anisodamine) and Buscopan® (hyoscine butylbromide) in people with Intestinal Diseases, run by Boehringer Ingelheim at 20 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Intestinal Diseases
What is being tested?: 654-II (anisodamine) and Buscopan® (hyoscine butylbromide)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 20 sitesChina
Study dates: Aug 2013to Feb 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 25Show fewer

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
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
Pregnancy and/or lactation or planned pregnancy;
Known hypersensitivity to N-butylscopolammonium bromide
Alcohol, or drug abuse.
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.
Unwilling to or unable to complete the entire trial procedure according to the protocol.
In investigator's opinion, the patient is not proper for the trial.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

China20 sites

202.848.86016 Boehringer Ingelheim Investigational Site
Baotou
202.848.86008 Boehringer Ingelheim Investigational Site
Beijing
202.848.86009 Boehringer Ingelheim Investigational Site
Beijing
202.848.86010 Boehringer Ingelheim Investigational Site
Beijing
202.848.86013 Boehringer Ingelheim Investigational Site
Beijing
202.848.86012 Boehringer Ingelheim Investigational Site
Changchun
202.848.86020 Boehringer Ingelheim Investigational Site
Changsha
202.848.86018 Boehringer Ingelheim Investigational Site
Chenzhou
202.848.86007 Boehringer Ingelheim Investigational Site
Chongqing
202.848.86021 Boehringer Ingelheim Investigational Site
Chongqing
202.848.86006 Boehringer Ingelheim Investigational Site
Guangzhou
202.848.86003 Boehringer Ingelheim Investigational Site
Hangzhou
202.848.86022 Boehringer Ingelheim Investigational Site
Huanggang
202.848.86001 Boehringer Ingelheim Investigational Site
Shanghai
202.848.86011 Boehringer Ingelheim Investigational Site
Shanghai
202.848.86015 Boehringer Ingelheim Investigational Site
Shenyang
202.848.86014 Boehringer Ingelheim Investigational Site
Shijiazhuang
202.848.86019 Boehringer Ingelheim Investigational Site
Wenzhou
202.848.86004 Boehringer Ingelheim Investigational Site
Wuhan
202.848.86005 Boehringer Ingelheim Investigational Site
Wuhan

Other trials in China

About this study

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

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.

Conditions: Intestinal Diseases
Being tested: 654-II (anisodamine), Buscopan® (hyoscine butylbromide)
Medical subject headings: Intestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01929044
Study group	Role	What they receive
Buscopan® (hyoscine butylbromide)	Experimental	1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection Receives: 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 Receives: Drug: 654-II (anisodamine)

What is being measured

The primary outcome is the main question the study is designed to answer.

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'.
Measured: Baseline and 20 minutes after the first injection

Secondary outcomes (6)

PID From Pre-dose Baseline at 10 Minutes After 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'.
Measured: Baseline and 10 minutes after the first injection
PID From Pre-dose Baseline at 30 Minutes After 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'.
Measured: Baseline and 30 minutes after the first injection
PID From Pre-dose Baseline at 60 Minutes After 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'.
Measured: Baseline and 60 minutes after the first injection
PID From Pre-dose Baseline at 120 Minutes After 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'.
Measured: Baseline and 120 minutes after the first injection
Global Assessment of Efficacy by the Patient at 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).
Measured: 120 minutes after the first injection
Proportion of Patients Who Need the Second Injection
Proportion of patients who need the second injection at 20 minutes after the first injection.
Measured: 20 minutes after the first injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Feb 2015

First posted27 Aug 2013 (estimated)
Study startAug 2013
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01929044
Sponsor's protocol ID: 202.848
Status last verified: Jan 2016
First submitted: 22 Aug 2013
Last updated: 8 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer

All Intestinal Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01929044
Acronym / sponsor ID: 202.848
Conditions: Intestinal Diseases
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 27 Aug 2013 (estimated)
Results: Posted 8 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Buscopan® (hyoscine butylbromide)	Experimental	Drug: Buscopan® (hyoscine butylbromide)1st injection of Buscopan® solution 20mg, if necessary 2nd injection after 20min of the 1st injection
654-II(anisodamine)	Active comparator	Drug: 654-II (anisodamine)1st injection of 654-II solution 10mg, if necessary 2nd injection after 20min of the 1st injection

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (25 listed)

Patients with the following concomitant disease is not eligible for enrollment:
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:
Pregnancy and/or lactation or planned pregnancy;
Known hypersensitivity to N-butylscopolammonium bromide
Alcohol, or drug abuse.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
654-II (anisodamine)10mg injection	Drug	654-II(anisodamine)
Buscopan® (hyoscine butylbromide)20mg injection	Drug	Buscopan® (hyoscine butylbromide)

Primary outcome

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'.

6 secondary outcomes

PID From Pre-dose Baseline at 10 Minutes After First Injection.
Time frame: 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
PID From Pre-dose Baseline at 60 Minutes After First Injection.
Time frame: 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
Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection
Time frame: 120 minutes after the first injection
Proportion of Patients Who Need the Second Injection
Time frame: 20 minutes after the first injection.

Results and safety

Results posted to the registry on 8 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buscopan® (Hyoscine Butylbromide)	153	142
654-II (Anisodamine)	146	129

Primary outcome: PID From Pre-dose Baseline at 20 Minutes After First Injection.

Time frame: Baseline and 20 minutes after the first injection. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Buscopan® (Hyoscine Butylbromide) n = 142	654-II (Anisodamine) n = 127
Value	-4.09 (0.17)	-3.66 (0.18)

Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine): Mean Difference (Final Values): -0.42 (95% CI -0.88 to 0.04), p <0.0001, Mixed Models Analysis
Buscopan® (Hyoscine Butylbromide) vs 654-II (Anisodamine): Mean Difference (Final Values): -0.42 (95% CI -0.88 to 0.04), p = 0.0743, Mixed Models Analysis

Population analysed: Per-Protocol Set (PPS): All patients in full analysis set (FAS: all patients who provided any data for the primary efficacy endpoint constituted the full analysis set.), who revealed no important protocol violations that would impact the analysis of primary endpoint

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first study drug application until 2 days (inclusive) after the last study drug application. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buscopan® (Hyoscine Butylbromide)	1 of 153 (0.7%)	12 of 153 (7.8%)	Not reported
654-II (Anisodamine)	0 of 142 (0%)	10 of 142 (7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Intestinal Diseases

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 654-II (anisodamine) and Buscopan® (hyoscine butylbromide) in people with Intestinal Diseases, run by Boehringer Ingelheim at 20 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PID From Pre-dose Baseline at 20 Minutes After First Injection. (time frame: Baseline and 20 minutes after the first injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01929044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.