Status:
COMPLETED
(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Abdominal Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2010
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00932737
Start Date
June 9 2009
End Date
February 8 2010
Last Update
May 3 2022
Active Locations (19)
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1
202.839.01014 Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
2
202.839.01003 Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
3
202.839.01001 Boehringer Ingelheim Investigational Site
Jupiter, Florida, United States
4
202.839.01002 Boehringer Ingelheim Investigational Site
Jupiter, Florida, United States