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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00932737
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : May 16, 2014
Information provided by:
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Drug: Placebo Drug: HBB 20 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2009
Actual Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: HBB 20mg 1-5 tablets per episode
patient to receive 1-5 tablets containing 20mg HBB per APC episode
Drug: Placebo
1-5 tablets per episode

Drug: HBB 20 mg
Active drug, one to five tablets per episode

Placebo Comparator: Placebo
patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode
Drug: Placebo
1-5 tablets per episode

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00932737

United States, California
202.839.01014 Boehringer Ingelheim Investigational Site
Westlake Village, California, United States
United States, Florida
202.839.01003 Boehringer Ingelheim Investigational Site
Hollywwod, Florida, United States
202.839.01001 Boehringer Ingelheim Investigational Site
Jupiter, Florida, United States
202.839.01002 Boehringer Ingelheim Investigational Site
Jupiter, Florida, United States
United States, Illinois
202.839.01017 Boehringer Ingelheim Investigational Site
Rockford, Illinois, United States
United States, Indiana
202.839.01005 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
United States, Maryland
202.839.01019 Boehringer Ingelheim Investigational Site
Chevy Chase, Maryland, United States
United States, Massachusetts
202.839.01009 Boehringer Ingelheim Investigational Site
Boston, Massachusetts, United States
United States, New Hampshire
202.839.01004 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire, United States
United States, New Jersey
202.839.01011 Boehringer Ingelheim Investigational Site
Toms River, New Jersey, United States
United States, New York
202.839.01008 Boehringer Ingelheim Investigational Site
Lake Success, New York, United States
United States, Ohio
202.839.01015 Boehringer Ingelheim Investigational Site
Cleveland, Ohio, United States
United States, Oklahoma
202.839.01021 Boehringer Ingelheim Investigational Site
Norman, Oklahoma, United States
202.839.01010 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
202.839.01013 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Texas
202.839.01006 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
202.839.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
202.839.01007 Boehringer Ingelheim Investigational Site
Virginia Beach, Virginia, United States
United States, Wisconsin
202.839.01020 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00932737     History of Changes
Other Study ID Numbers: 202.839
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: October 2013

Additional relevant MeSH terms:
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists