Clinical trial NCT00932737: (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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
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
timeFrame: 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
measure: Change From Baseline in Intensity of Abdominal Pain Associated With Cramping Following Treatment Based on the Numeric Pain Rating Scale (NPRS) in Episode 2
timeFrame: 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.
measure: Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 1
timeFrame: 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.
measure: Area Under the Curve (AUC) Calculated From the Responses to the Numeric Pain Rating Scale (NPRS) Scores in Episode 2
timeFrame: 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.
measure: Percentage of Participants With Response of "no Pain" Based on Numeric Pain Rating Scale (NPRS) in Episode 1
timeFrame: At 4 hours after intake of first tablet of study medication in episode 1
measure: Percentage of Participants With Response of no Pain Based on Numeric Pain Rating Scale (NPRS) in Episode 2
timeFrame: At 4 hours after intake of first tablet of study medication in episode 2
measure: Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 1
timeFrame: At 4 hours after intake of first tablet of study medication in episode 1
measure: Percentage of Participants With Response Based on the Patient Global Impression of Change (PGI-C) of "Much Better" in Episode 2
timeFrame: At 4 hours after intake of first tablet of study medication in episode 2
measure: Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 1
timeFrame: At 4 hours after intake of first tablet of study medication in episode 1
measure: Percentage of Participants With Response Based on the 4-point Verbal Rating Scale (VRS) of "Very Satisfied" in Episode 2
timeFrame: At 4 hours after intake of first tablet of study medication in episode 2
measure: Time to Relief in Episode 1
timeFrame: From intake of first tablet of study medication up to 4 hours thereafter in episode 1
measure: Time to Relief in Episode 2
timeFrame: From intake of first tablet of study medication up to 4 hours thereafter in episode 2
measure: Number of Tablets of Study Medication Taken
timeFrame: From intake of first tablet of study medication up to 4 hours thereafter in each episode.
Secondary outcomes:
measure: Percentage of Patients With Drug-related Adverse Events
timeFrame: From the first dose of study medication until 3 days after the last dose for each episode. Up to 8 days.
measure: Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 1
timeFrame: At 4 hours after intake of first tablet of study medication in episode 1
measure: Number of Participants Per Verbal Rating Scale Assessing Participant's Global Assessment of Tolerability in Episode 2
timeFrame: At 4 hours after intake of first tablet of study medication in episode 2
measure: Change From Baseline to End of Study Visit in Systolic Blood Pressure
timeFrame: At baseline (intake of the first tablet of trial medication in the study) and day 28 (end of study visit)
measure: Change From Baseline to End of Study Visit in Diastolic Blood Pressure
timeFrame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
measure: Change From Baseline to End of Study Visit in Pulse Rate
timeFrame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
measure: Change From Baseline to End of Study Visit in Body Temperature
timeFrame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
measure: Change From Baseline to End of Study Visit in Respiratory Rate
timeFrame: At baseline (intake of the first tablet of trial medication in the study) and day 28 of end of study visit
Other outcomes:
Locations:
city: Westlake Village
country: United States
facility: 202.839.01014 Boehringer Ingelheim Investigational Site
state: California
city: Hollywood
country: United States
facility: 202.839.01003 Boehringer Ingelheim Investigational Site
state: Florida
city: Jupiter
country: United States
facility: 202.839.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: Jupiter
country: United States
facility: 202.839.01002 Boehringer Ingelheim Investigational Site
state: Florida
city: Rockford
country: United States
facility: 202.839.01017 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 202.839.01005 Boehringer Ingelheim Investigational Site
state: Indiana
city: Chevy Chase
country: United States
facility: 202.839.01019 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 202.839.01009 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Lebanon
country: United States
facility: 202.839.01004 Boehringer Ingelheim Investigational Site
state: New Hampshire
city: Toms River
country: United States
facility: 202.839.01011 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Lake Success
country: United States
facility: 202.839.01008 Boehringer Ingelheim Investigational Site
state: New York
city: Cleveland
country: United States
facility: 202.839.01015 Boehringer Ingelheim Investigational Site
state: Ohio
city: Norman
country: United States
facility: 202.839.01021 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: 202.839.01010 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: 202.839.01013 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: 202.839.01006 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 202.839.01012 Boehringer Ingelheim Investigational Site
state: Texas
city: Virginia Beach
country: United States
facility: 202.839.01007 Boehringer Ingelheim Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: 202.839.01020 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: