(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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).
Trial design
Primary purpose
Allocation
Interventional model
Masking
197 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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