Abdominal PainPhase 3NCT02242305

Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort

A Phase 3 study testing Hyoscine Butylbromide - Tablet and Hyoscine Butylbromide - Capsule in people with Abdominal Pain, run by Boehringer Ingelheim.

Completed

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

Official record

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Trial summary

In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Abdominal Pain
What is being tested?: Hyoscine Butylbromide - Tablet and Hyoscine Butylbromide - Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: No sites listed yet
Study dates: 1 Nov 2008to 20 Jul 2009
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

Written Informed Consent given by the patient
Male and female patients aging from 18 to 70
Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months
The pain intensity score upon screening is at least 4 cm in VAS score

Who cannot join

Patients with the following concomitant disease were not eligible for enrolment
Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception: diverticulitis and mild gastritis if dominant symptom was cramp pain, but ineligible if heartburn or reflux were dominant symptoms
Pain related with malignancy
Patients with other severe pain states of organic origin
Mechanical stenosis of the gastrointestinal tract, megacolon
Urinary retention associated with mechanical stenosis of urinary tract

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Narrow-angled glaucoma
Tachyarrhythmia
Myasthenia gravis
Meulengracht-Gilbert syndrome
Known depression or known mental illness, anxiety disturbance
Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
Patients taking the following concomitant medication are not eligible for enrolment
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 enrolment is forbidden
Unwilling to or unable to complete the entire trial procedure according to the protocol
In investigator's opinion, the patient was not proper for the trial

About this study

Official title: A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Hyoscine Butylbromide Capsule 10mg, to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets 10 mg (20mg, 3 Times Daily, Orally) Over a Period of 3 Days for the Treatment of Occasional or Recurrent Episodes of Self-reported Gastric or Intestinal Spasm-like Pain

Conditions: Abdominal Pain
Being tested: Hyoscine Butylbromide - Tablet, Hyoscine Butylbromide - Capsule, Placebo
Medical subject headings: Abdominal Pain

What participants receive

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

Hyoscine Butylbromide - TabletDrug
Hyoscine Butylbromide - CapsuleDrug
PlaceboDrug

Study groups in NCT02242305
Study group	Role	What they receive
Hyoscine Butylbromide - Tablet	Experimental	Not described Receives: Drug: Hyoscine Butylbromide - Tablet; Drug: Placebo
Hyoscine Butylbromide - Capsule	Active comparator	Not described Receives: Drug: Hyoscine Butylbromide - Capsule; Drug: Placebo

What is being measured

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

Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").
Measured: 3 days (1 day)

Secondary outcomes (6)

Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: "How many times have the spasm-like pains occurred today?" 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.
Measured: Up to 3 days.
Global Assessment of Efficacy by Patient on 4-point Scale
The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).
Measured: Post 3 days of treatment.
Number of Patients With Adverse Events
The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.
Measured: Up to 3 days.
Global Assessment of Tolerability by Investigator on a 4-point Scale
The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).
Measured: Day 3.
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).
Measured: Up to 3 days.
Percentage of Event for Time to Therapeutic Effect
This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.
Measured: From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.

Timeline

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

1 Nov 200820 Jul 2009

First posted17 Sep 2014 (estimated)
Study start1 Nov 2008
Primary completion20 Jul 2009
Study completion20 Jul 2009

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 Abdominal PainStudies 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
Who is masked: Participant, Investigator
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02242305
Sponsor's protocol ID: 202.838
Status last verified: Jul 2017
First submitted: 16 Sep 2014
Last updated: 27 Jul 2017
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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Hyoscine Butylbromide Capsule 10mg, to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets 10 mg (20mg, 3 Times Daily, Orally) Over a Period of 3 Days for the Treatment of Occasional or Recurrent Episodes of Self-reported Gastric or Intestinal Spasm-like Pain
ClinicalTrials.gov ID: NCT02242305
Acronym / sponsor ID: 202.838
Conditions: Abdominal Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Nov 2008 (actual)
Primary completion: 20 Jul 2009 (actual)
Study completion: 20 Jul 2009 (actual)
First posted: 17 Sep 2014 (estimated)
Results: Posted 27 Jul 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Hyoscine Butylbromide - Tablet	Experimental	Drug: Hyoscine Butylbromide - Tablet, Drug: Placebo
Hyoscine Butylbromide - Capsule	Active comparator	Drug: Hyoscine Butylbromide - Capsule, Drug: Placebo

Who may qualify

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

Key inclusion criteria (4 listed)

Written Informed Consent given by the patient
Male and female patients aging from 18 to 70
Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months
The pain intensity score upon screening is at least 4 cm in VAS score

Key exclusion criteria (26 listed)

Patients with the following concomitant disease were not eligible for enrolment
Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
Patients taking the following concomitant medication are not eligible for enrolment
Pregnancy and/or lactation or planned pregnancy
Known hypersensitivity to N-butylscopolammonium bromide

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
Hyoscine Butylbromide - Tablet	Drug	Hyoscine Butylbromide - Tablet
Hyoscine Butylbromide - Capsule	Drug	Hyoscine Butylbromide - Capsule
Placebo	Drug	Hyoscine Butylbromide - Capsule, Hyoscine Butylbromide - Tablet

Primary outcome

Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
Time frame: 3 days (1 day)
The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").

6 secondary outcomes

Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
Time frame: Up to 3 days.
Global Assessment of Efficacy by Patient on 4-point Scale
Time frame: Post 3 days of treatment.
Number of Patients With Adverse Events
Time frame: Up to 3 days.
Global Assessment of Tolerability by Investigator on a 4-point Scale
Time frame: Day 3.
Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
Time frame: Up to 3 days.
Percentage of Event for Time to Therapeutic Effect
Time frame: From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.

Results and safety

Results posted to the registry on 27 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hyoscine Butylbromide - Tablet (Tab.)	151	145
Hyoscine Butylbromide - Capsule (Cap.)	151	141

Primary outcome: Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA

Time frame: 3 days (1 day). Number. Unit: Units on a scale

Measure	Hyoscine Butylbromide - Tablet n = 141	Hyoscine Butylbromide - Capsule n = 140
Within 3 days	-2.48 (1.968)	-2.45 (1.879)
Within 1 day	-2.36 (1.984)	-2.31 (1.914)

Hyoscine Butylbromide - Tablet vs Hyoscine Butylbromide - Capsule: Mean Difference (Final Values): -0.03 (90% CI -0.33 to 0.27), p = 0.809, ANCOVA
Hyoscine Butylbromide - Tablet vs Hyoscine Butylbromide - Capsule: Median Difference (Final Values): -0.05 (95% CI -0.39 to 0.33), p = 0.809, ANCOVA

Population analysed: Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 3 days after last drug administration, up to 284 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hyoscine Butylbromide - Tablet	0 of 146 (0%)	0 of 146 (0%)	Not reported
Hyoscine Butylbromide - Capsule	0 of 142 (0%)	0 of 142 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hyoscine Butylbromide - Tablet and Hyoscine Butylbromide - Capsule in people with Abdominal Pain, run by Boehringer Ingelheim.

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 4 inclusion and 26 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

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 27 Jul 2017). 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?

Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA (time frame: 3 days (1 day)). 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 NCT02242305.

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 27 Jul 2017.