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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00932737
First received: June 17, 2009
Last updated: April 30, 2014
Last verified: October 2013
  Purpose

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 Intervention Phase
Abdominal Pain
Drug: Placebo
Drug: HBB 20 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Secondary Outcome Measures:
  • Adverse events. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient's global assessment of tolerability. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Physical examination: changes in pulse rate, diastolic and systolic blood pressure, [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • body temperature and respiratory rate. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: June 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932737

Locations
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
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00932737     History of Changes
Other Study ID Numbers: 202.839, U09-3181-01
Study First Received: June 17, 2009
Last Updated: April 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Butylscopolammonium Bromide
Scopolamine Hydrobromide
Adjuvants, Anesthesia
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014