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NCT00932737 Clinical Trial

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

Abdominal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00932737
Other study ID # 202.839
Secondary ID U09-3181-01
Status Completed
Phase Phase 2
First received
Last updated
Start date June 9, 2009
Est. completion date February 8, 2010

Study information
Verified date April 2022
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 197
Est. completion date February 8, 2010
Est. primary completion date February 8, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
1-5 tablets per episode
• HBB 20 mg
Active drug, one to five tablets per episode

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

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 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
Primary 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). 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.
Primary 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). 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.
Primary 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). 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.
Primary 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. At 4 hours after intake of first tablet of study medication in episode 1
Primary 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. At 4 hours after intake of first tablet of study medication in episode 2
Primary 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". At 4 hours after intake of first tablet of study medication in episode 1
Primary 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". At 4 hours after intake of first tablet of study medication in episode 2
Primary 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". At 4 hours after intake of first tablet of study medication in episode 1
Primary 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". At 4 hours after intake of first tablet of study medication in episode 2
Primary 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. From intake of first tablet of study medication up to 4 hours thereafter in episode 1
Primary 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. From intake of first tablet of study medication up to 4 hours thereafter in episode 2
Primary Number of Tablets of Study Medication Taken Number of tablets of study medication taken in each of the two episode. From intake of first tablet of study medication up to 4 hours thereafter in each episode.
Secondary 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.
Secondary 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"). At 4 hours after intake of first tablet of study medication in episode 1
Secondary 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") At 4 hours after intake of first tablet of study medication in episode 2
Secondary 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. At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
Secondary 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. At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Secondary 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. At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Secondary 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. At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Secondary 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. At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
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