Abdominal PainPhase 2NCT00932737

(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis

A Phase 2 study testing HBB 20 mg in people with Abdominal Pain, run by Boehringer Ingelheim at 19 sites in United States.

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

The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Pain
What is being tested?: HBB 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 197 participants
Where: 19 sitesUnited States
Study dates: 9 Jun 2009to 8 Feb 2010
Phase: Phase 2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of recurrent abdominal pain with cramping (APC) for at least three months.
Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.

Who cannot join

Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

202.839.01009 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
202.839.01019 Boehringer Ingelheim Investigational Site
Chevy Chase, Maryland
202.839.01015 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
202.839.01003 Boehringer Ingelheim Investigational Site
Hollywood, Florida
202.839.01005 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
202.839.01001 Boehringer Ingelheim Investigational Site
Jupiter, Florida
202.839.01002 Boehringer Ingelheim Investigational Site
Jupiter, Florida
202.839.01008 Boehringer Ingelheim Investigational Site
Lake Success, New York
202.839.01004 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire
202.839.01020 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
202.839.01021 Boehringer Ingelheim Investigational Site
Norman, Oklahoma
202.839.01010 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
202.839.01013 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
202.839.01017 Boehringer Ingelheim Investigational Site
Rockford, Illinois
202.839.01006 Boehringer Ingelheim Investigational Site
San Antonio, Texas
202.839.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas
202.839.01011 Boehringer Ingelheim Investigational Site
Toms River, New Jersey
202.839.01007 Boehringer Ingelheim Investigational Site
Virginia Beach, Virginia
202.839.01014 Boehringer Ingelheim Investigational Site
Westlake Village, California

Other trials in United States

About this study

Official title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Pilot Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used on Demand for the Treatment of Self-reported Functional Abdominal Pain Associated With Cramping

Conditions: Abdominal Pain
Being tested: Placebo, HBB 20 mg
Medical subject headings: Abdominal Pain

What participants receive

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

PlaceboDrug
1-5 tablets per episode
HBB 20 mgDrug
Active drug, one to five tablets per episode

Study groups in NCT00932737
Study group	Role	What they receive
Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode	Active comparator	Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode Receives: Drug: HBB 20 mg
Placebo	Placebo comparator	patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Measured: At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Measured: At 4 hours after intake of first tablet of study medication in episode 1
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Measured: At 4 hours after intake of first tablet of study medication in episode 2
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
Measured: At 4 hours after intake of first tablet of study medication in episode 1
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
Measured: At 4 hours after intake of first tablet of study medication in episode 2
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
Measured: At 4 hours after intake of first tablet of study medication in episode 1
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
Measured: At 4 hours after intake of first tablet of study medication in episode 2
Time to Relief in Episode 1
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1.
Measured: From intake of first tablet of study medication up to 4 hours thereafter in episode 1
Time to Relief in Episode 2
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.
Measured: From intake of first tablet of study medication up to 4 hours thereafter in episode 2
Number of Tablets of Study Medication Taken
Number of tablets of study medication taken in each of the two episode.
Measured: From intake of first tablet of study medication up to 4 hours thereafter in each episode.

Secondary outcomes (8)

Percentage of Patients With Drug-related Adverse Events
Measured: From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1
Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?" ("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied").
Measured: At 4 hours after intake of first tablet of study medication in episode 1
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2
Patient's global assessment of tolerability following treatment of an episode of Abdominal pain associated with cramping (APC) was based on a 4-point Verbal rating scale (VRS) in patient's response to the question, "Overall, how satisfied were you with the medication in terms of side effects during this episode?" ("Very Satisfied," "Satisfied," "Dissatisfied," "Very Dissatisfied")
Measured: At 4 hours after intake of first tablet of study medication in episode 2
Change From Baseline to End of Study Visit in Systolic Blood Pressure
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in systolic blood pressure.
Measured: At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
Change From Baseline to End of Study Visit in Diastolic Blood Pressure
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in diastolic blood pressure.
Measured: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Change From Baseline to End of Study Visit in Pulse Rate
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in pulse rate.
Measured: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Change From Baseline to End of Study Visit in Body Temperature
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature.
Measured: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Change From Baseline to End of Study Visit in Respiratory Rate
Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate.
Measured: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Timeline

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

9 Jun 20098 Feb 2010

First posted3 Jul 2009 (estimated)
Study start9 Jun 2009
Primary completion8 Feb 2010
Study completion8 Feb 2010

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932737
Sponsor's protocol ID: 202.839
Other IDs: U09-3181-01
Status last verified: Apr 2022
First submitted: 17 Jun 2009
Last updated: 3 May 2022
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

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomized, Parallel-group Pilot Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used on Demand for the Treatment of Self-reported Functional Abdominal Pain Associated With Cramping
ClinicalTrials.gov ID: NCT00932737
Acronym / sponsor ID: 202.839
Conditions: Abdominal Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 9 Jun 2009 (actual)
Primary completion: 8 Feb 2010 (actual)
Study completion: 8 Feb 2010 (actual)
First posted: 3 Jul 2009 (estimated)
Results: Posted 3 May 2022

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
Number of arms: 2

Arm	Type	Receives
Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode	Active comparator	Drug: HBB 20 mgPatient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode
Placebo	Placebo comparator	Drug: Placebopatient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode

Who may qualify

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

Key inclusion criteria (2 listed)

History of recurrent abdominal pain with cramping (APC) for at least three months.
Recorded at least two episodes of APC of at least "moderate" intensity (i.e., 5 or above on a 0-10 point scale) lasting one hour in the eDiary during the run-in period.

Key exclusion criteria (1 listed)

Experiencing daily episode of APC during Run-in period Active gastrointestinal disease during the past 12 months including malignancy, inflammatory bowel disease, celiac disease or complete or partial bowel obstruction and who have undergone major gastrointestinal surgery with the past 12 months (patients with history of appendectomy, cholecystectomy, bilateral tubal ligation and c-section within past 12 months are allowed in the study).

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
Placebo1-5 tablets per episode	Drug	Placebo
HBB 20 mgActive drug, one to five tablets per episode	Drug	Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode

Primary outcome

Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1
Time frame: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
Time frame: At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
Time frame: At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
Time frame: At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
The intensity of Abdominal pain associated with cramping was rated on an 11-point numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Responses of "no pain" (NPRS = 0) based on the 0 to 10 point NPRS scale were summarized.
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Compared to just before you took the first tablet of study medication, how would you rate your abdominal pain associated with cramping now?" based on the Patient global impression of change (PGI-C), using the available responses: "Much better", "Somewhat better", "A little better", "No change", "A little worse", and "Somewhat worse".
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
At episode 1, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
At episode 2, after the intake of first tablet of study medication, the patient then responded to the question of "Overall, how satisfied were you with the medication in terms of effectiveness for this episode?" based on the 4-point Verbal rating scale (VRS) using the available response: "Very Satisfied", "Satisfied", "Dissatisfied", and "Very Dissatisfied".
Time to Relief in Episode 1
Time frame: From intake of first tablet of study medication up to 4 hours thereafter in episode 1
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 1.
Time to Relief in Episode 2
Time frame: From intake of first tablet of study medication up to 4 hours thereafter in episode 2
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.
Number of Tablets of Study Medication Taken
Time frame: From intake of first tablet of study medication up to 4 hours thereafter in each episode.
Number of tablets of study medication taken in each of the two episode.

8 secondary outcomes

Percentage of Patients With Drug-related Adverse Events
Time frame: From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1
Time frame: At 4 hours after intake of first tablet of study medication in episode 1
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2
Time frame: At 4 hours after intake of first tablet of study medication in episode 2
Change From Baseline to End of Study Visit in Systolic Blood Pressure
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
Change From Baseline to End of Study Visit in Diastolic Blood Pressure
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Change From Baseline to End of Study Visit in Pulse Rate
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Change From Baseline to End of Study Visit in Body Temperature
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Change From Baseline to End of Study Visit in Respiratory Rate
Time frame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit

Results and safety

Results posted to the registry on 3 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	87	86
Hyoscine Butylbromide (Buscopan®) 20 mg	88	87

Primary outcome: Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1

Time frame: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 87	Hyoscine Butylbromide (Buscopan®) 20 mg n = 88
Value	-2.7 (3.10)	-3.1 (3.05)

Placebo vs Hyoscine Butylbromide (Buscopan®) 20 mg: Adjusted mean difference: -0.7 (95% CI -1.3 to -0.1), p = 0.0156, Mixed effect model

Population analysed: Full analysis set (FAS): This patient set includes all treated patients who experienced at least one episode of Abdominal pain associated with cramping (APC) and took at least one dose of study medication to treat the symptoms and had baseline rating of APC in that episode over a four week period following randomization.

Primary outcome: Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2

Time frame: At baseline (prior to intake of first tablet of study medication in episode 2) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours.. Mean (Standard Deviation). Unit: Score on a scale

Measure	Placebo n = 72	Hyoscine Butylbromide (Buscopan®) 20 mg n = 78
Value	-2.9 (3.15)	-3.2 (3.06)

Placebo vs Hyoscine Butylbromide (Buscopan®) 20 mg: Adjusted mean difference: -0.6 (95% CI -1.2 to 0.0), p = 0.0512, Mixed effect model

Primary outcome: Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1

Time frame: At baseline (prior to intake of first tablet of study medication for episode 1) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.. Mean (Standard Deviation). Unit: Score * hours

Measure	Placebo n = 87	Hyoscine Butylbromide (Buscopan®) 20 mg n = 88
Value	-3.71 (2.42)	-4.32 (2.27)

Placebo vs Hyoscine Butylbromide (Buscopan®) 20 mg: Adjusted mean difference: -0.7 (95% CI -1.3 to 0.0), p = 0.0351, ANCOVA

Primary outcome: Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2

Time frame: At baseline (prior to intake of first tablet of study medication for episode 2) and 15 minutes(min), 30min, 45min, 1 hour(h), 1h30min, 2h, 2h30min, 3h, 3h30min, and 4h thereafter.. Mean (Standard Deviation). Unit: Score * hours

Measure	Placebo n = 72	Hyoscine Butylbromide (Buscopan®) 20 mg n = 78
Value	-4.17 (2.51)	-4.40 (2.32)

Placebo vs Hyoscine Butylbromide (Buscopan®) 20 mg: Adjusted mean difference: -0.3 (95% CI -1.0 to 0.4), p = 0.3557, ANCOVA

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose until end of study visit + 3 days, up to 31 days for all-cause mortality; From first dose until 3 days after last dose for each episode, up to 8 days for (serious) adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 87 (0%)	0 of 87 (0%)	0 of 87
Hyoscine Butylbromide (Buscopan®) 20 mg	1 of 88 (1.1%)	0 of 88 (0%)	0 of 88

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HBB 20 mg in people with Abdominal Pain, run by Boehringer Ingelheim at 19 sites in United States.

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 2 inclusion and 1 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 May 2022). 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 From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1 (time frame: At baseline (prior to intake of first tablet of study medication in episode 1) until 4 hours thereafter or until the patient had responded that their pain was absent, up to 4 hours). The study lists 13 primary outcomes in all. 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 NCT00932737.

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 3 May 2022.