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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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-reporte

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 Summary:
Sponsor: Boehringer Ingelheim

Current Primary Outcome:

  • Change from baseline in intensity of APC based on the 0 to 10 point scale. [ Time Frame: 4 hours ]
  • Area under the curve (AUC) calculated from the responses to the 0 to 10 point scale. [ Time Frame: 4 hours ]
  • Response based the 0 to 10 point scale as defined by: a response of no pain at any interval. [ Time Frame: 4 hours ]
  • Response based the 7-point Patient Global Impression of Change (PGI-C) [ Time Frame: 4 weeks ]
  • Response based the 4-point Verbal Rating Scale (VRS) of the patient's global assessment of efficacy [ Time Frame: 4 weeks ]
  • Time to relief [ Time Frame: 4 weeks ]
  • Number of tablets of study medication taken [ Time Frame: 4 weeks ]


Original Primary Outcome: Change from baseline in intensity of APC based on the 0 to 10 point scale. Area under the curve (AUC) calculated from the responses to the 0 to 10 point scale. Response based the 0 to 10 point scale as defined by: a response of no pain at any interval. [ Time Frame: 4 hours ]

Current Secondary Outcome:

  • Adverse events. [ Time Frame: 4 weeks ]
  • Patient's global assessment of tolerability. [ Time Frame: 4 weeks ]
  • Physical examination: changes in pulse rate, diastolic and systolic blood pressure, [ Time Frame: 4 weeks ]
  • body temperature and respiratory rate. [ Time Frame: 4 weeks ]


Original Secondary Outcome: Adverse events. Patient¿s global assessment of tolerability. Physical examination: changes in pulse rate, diastolic and systolic blood pressure, body temperature and respiratory rate. [ Time Frame: 4 weeks ]

Information By: Boehringer Ingelheim

Dates:
Date Received: June 17, 2009
Date Started: June 2009
Date Completion:
Last Updated: April 30, 2014
Last Verified: October 2013