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

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
HBB 20 mg
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Sites / Locations

  • 202.839.01014 Boehringer Ingelheim Investigational Site
  • 202.839.01003 Boehringer Ingelheim Investigational Site
  • 202.839.01001 Boehringer Ingelheim Investigational Site
  • 202.839.01002 Boehringer Ingelheim Investigational Site
  • 202.839.01017 Boehringer Ingelheim Investigational Site
  • 202.839.01005 Boehringer Ingelheim Investigational Site
  • 202.839.01019 Boehringer Ingelheim Investigational Site
  • 202.839.01009 Boehringer Ingelheim Investigational Site
  • 202.839.01004 Boehringer Ingelheim Investigational Site
  • 202.839.01011 Boehringer Ingelheim Investigational Site
  • 202.839.01008 Boehringer Ingelheim Investigational Site
  • 202.839.01015 Boehringer Ingelheim Investigational Site
  • 202.839.01021 Boehringer Ingelheim Investigational Site
  • 202.839.01010 Boehringer Ingelheim Investigational Site
  • 202.839.01013 Boehringer Ingelheim Investigational Site
  • 202.839.01006 Boehringer Ingelheim Investigational Site
  • 202.839.01012 Boehringer Ingelheim Investigational Site
  • 202.839.01007 Boehringer Ingelheim Investigational Site
  • 202.839.01020 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode

Placebo

Arm Description

Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode

patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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.
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.
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".
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".
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".
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".
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.
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.
Number of Tablets of Study Medication Taken
Number of tablets of study medication taken in each of the two episode.

Secondary Outcome Measures

Percentage of Patients With Drug-related Adverse Events
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").
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")
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.
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.
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.
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.
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.

Full Information

First Posted
June 17, 2009
Last Updated
April 6, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00932737
Brief Title
(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 9, 2009 (Actual)
Primary Completion Date
February 8, 2010 (Actual)
Study Completion Date
February 8, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode
Arm Type
Active Comparator
Arm Description
Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1-5 tablets per episode
Intervention Type
Drug
Intervention Name(s)
HBB 20 mg
Intervention Description
Active drug, one to five tablets per episode
Primary Outcome Measure Information:
Title
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1
Description
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).
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
Title
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
Description
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).
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.
Title
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
Description
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).
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.
Title
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
Description
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).
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.
Title
Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1
Description
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.
Time Frame
At 4 hours after intake of first tablet of study medication in episode 1
Title
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
Description
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.
Time Frame
At 4 hours after intake of first tablet of study medication in episode 2
Title
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1
Description
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".
Time Frame
At 4 hours after intake of first tablet of study medication in episode 1
Title
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2
Description
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".
Time Frame
At 4 hours after intake of first tablet of study medication in episode 2
Title
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1
Description
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".
Time Frame
At 4 hours after intake of first tablet of study medication in episode 1
Title
Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2
Description
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 Frame
At 4 hours after intake of first tablet of study medication in episode 2
Title
Time to Relief in Episode 1
Description
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 Frame
From intake of first tablet of study medication up to 4 hours thereafter in episode 1
Title
Time to Relief in Episode 2
Description
Time from intake of first tablet of study medication to first response of "no pain" (numeric pain rating scale (NPRS) = 0) in episode 2.
Time Frame
From intake of first tablet of study medication up to 4 hours thereafter in episode 2
Title
Number of Tablets of Study Medication Taken
Description
Number of tablets of study medication taken in each of the two episode.
Time Frame
From intake of first tablet of study medication up to 4 hours thereafter in each episode.
Secondary Outcome Measure Information:
Title
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.
Title
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1
Description
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").
Time Frame
At 4 hours after intake of first tablet of study medication in episode 1
Title
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2
Description
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")
Time Frame
At 4 hours after intake of first tablet of study medication in episode 2
Title
Change From Baseline to End of Study Visit in Systolic Blood Pressure
Description
Change from baseline (intake of the first tablet of trial medication in the study) 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)
Title
Change From Baseline to End of Study Visit in Diastolic Blood Pressure
Description
Change from baseline (intake of the first tablet of trial medication in the study) 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
Title
Change From Baseline to End of Study Visit in Pulse Rate
Description
Change from baseline (intake of the first tablet of trial medication in the study) 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
Title
Change From Baseline to End of Study Visit in Body Temperature
Description
Change from baseline (intake of the first tablet of trial medication in the study) 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
Title
Change From Baseline to End of Study Visit in Respiratory Rate
Description
Change from baseline (intake of the first tablet of trial medication in the study) 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
202.839.01014 Boehringer Ingelheim Investigational Site
City
Westlake Village
State/Province
California
Country
United States
Facility Name
202.839.01003 Boehringer Ingelheim Investigational Site
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
202.839.01001 Boehringer Ingelheim Investigational Site
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
202.839.01002 Boehringer Ingelheim Investigational Site
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
202.839.01017 Boehringer Ingelheim Investigational Site
City
Rockford
State/Province
Illinois
Country
United States
Facility Name
202.839.01005 Boehringer Ingelheim Investigational Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
202.839.01019 Boehringer Ingelheim Investigational Site
City
Chevy Chase
State/Province
Maryland
Country
United States
Facility Name
202.839.01009 Boehringer Ingelheim Investigational Site
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
202.839.01004 Boehringer Ingelheim Investigational Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
202.839.01011 Boehringer Ingelheim Investigational Site
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
202.839.01008 Boehringer Ingelheim Investigational Site
City
Lake Success
State/Province
New York
Country
United States
Facility Name
202.839.01015 Boehringer Ingelheim Investigational Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
202.839.01021 Boehringer Ingelheim Investigational Site
City
Norman
State/Province
Oklahoma
Country
United States
Facility Name
202.839.01010 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
202.839.01013 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
202.839.01006 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
202.839.01012 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
202.839.01007 Boehringer Ingelheim Investigational Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
202.839.01020 Boehringer Ingelheim Investigational Site
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mystudywindow.com/
Description
Related Info

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

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