(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
- Conditions
- Abdominal Pain
- Interventions
- Drug: PlaceboDrug: HBB 20 mg
- Registration Number
- NCT00932737
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
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.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode HBB 20 mg Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode
- Primary Outcome Measures
Name Time Method Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1 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".
Time to Relief in Episode 2 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 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.
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1 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).
Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1 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.
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2 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).
Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2 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.
Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 1 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).
Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2 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 Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2 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 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.
Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2 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 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".
- Secondary Outcome Measures
Name Time Method Percentage of Patients With Drug-related Adverse Events 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 At 4 hours after intake of first tablet of study medication 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").
Change From Baseline to End of Study Visit in Systolic Blood Pressure At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit) 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 Respiratory Rate At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in respiratory rate.
Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2 At 4 hours after intake of first tablet of study medication 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 Diastolic Blood Pressure At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit 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 At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit 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 At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit Change from baseline (intake of the first tablet of trial medication in the study) to end of study visit in body temperature.
Trial Locations
- Locations (19)
202.839.01003 Boehringer Ingelheim Investigational Site
🇺🇸Hollywood, Florida, United States
202.839.01005 Boehringer Ingelheim Investigational Site
🇺🇸Indianapolis, Indiana, United States
202.839.01009 Boehringer Ingelheim Investigational Site
🇺🇸Boston, Massachusetts, United States
202.839.01021 Boehringer Ingelheim Investigational Site
🇺🇸Norman, Oklahoma, United States
202.839.01007 Boehringer Ingelheim Investigational Site
🇺🇸Virginia Beach, Virginia, United States
202.839.01006 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
202.839.01012 Boehringer Ingelheim Investigational Site
🇺🇸San Antonio, Texas, United States
202.839.01004 Boehringer Ingelheim Investigational Site
🇺🇸Lebanon, New Hampshire, United States
202.839.01001 Boehringer Ingelheim Investigational Site
🇺🇸Jupiter, Florida, United States
202.839.01002 Boehringer Ingelheim Investigational Site
🇺🇸Jupiter, Florida, United States
202.839.01014 Boehringer Ingelheim Investigational Site
🇺🇸Westlake Village, California, United States
202.839.01017 Boehringer Ingelheim Investigational Site
🇺🇸Rockford, Illinois, United States
202.839.01011 Boehringer Ingelheim Investigational Site
🇺🇸Toms River, New Jersey, United States
202.839.01015 Boehringer Ingelheim Investigational Site
🇺🇸Cleveland, Ohio, United States
202.839.01019 Boehringer Ingelheim Investigational Site
🇺🇸Chevy Chase, Maryland, United States
202.839.01008 Boehringer Ingelheim Investigational Site
🇺🇸Lake Success, New York, United States
202.839.01013 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
202.839.01010 Boehringer Ingelheim Investigational Site
🇺🇸Oklahoma City, Oklahoma, United States
202.839.01020 Boehringer Ingelheim Investigational Site
🇺🇸Milwaukee, Wisconsin, United States