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

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ClinicalTrials.gov Identifier: NCT00932737
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : May 16, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

June 17, 2009
July 3, 2009
May 16, 2014
June 2009
February 2010   (Final data collection date for primary outcome measure)
  • 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 ]
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 ]
Complete list of historical versions of study NCT00932737 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
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(Hyoscine Butylbromide) for Abdominal Pain Associated With Cramping on Demand Basis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Abdominal Pain
  • Drug: Placebo
    1-5 tablets per episode
  • Drug: HBB 20 mg
    Active drug, one to five tablets per episode
  • Active Comparator: HBB 20mg 1-5 tablets per episode
    patient to receive 1-5 tablets containing 20mg HBB per APC episode
    Interventions:
    • Drug: Placebo
    • Drug: HBB 20 mg
  • Placebo Comparator: Placebo
    patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
220
Not Provided
February 2010   (Final data collection date for primary outcome measure)

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).

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00932737
202.839
U09-3181-01
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP