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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abdominal Pain

Intervention: Placebo (Drug); Placebo (Drug); HBB 20 mg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.

Response based the 7-point Patient Global Impression of Change (PGI-C)

Response based the 4-point Verbal Rating Scale (VRS) of the patient's global assessment of efficacy

Time to relief

Number of tablets of study medication taken

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

202.839.01014 Boehringer Ingelheim Investigational Site, Westlake Village, California, United States

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

202.839.01017 Boehringer Ingelheim Investigational Site, Rockford, Illinois, United States

202.839.01005 Boehringer Ingelheim Investigational Site, Indianapolis, Indiana, United States

202.839.01019 Boehringer Ingelheim Investigational Site, Chevy Chase, Maryland, United States

202.839.01009 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States

202.839.01004 Boehringer Ingelheim Investigational Site, Lebanon, New Hampshire, United States

202.839.01011 Boehringer Ingelheim Investigational Site, Toms River, New Jersey, United States

202.839.01008 Boehringer Ingelheim Investigational Site, Lake Success, New York, United States

202.839.01015 Boehringer Ingelheim Investigational Site, Cleveland, Ohio, United States

202.839.01021 Boehringer Ingelheim Investigational Site, Norman, Oklahoma, United States

202.839.01010 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

202.839.01013 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

202.839.01006 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States

202.839.01012 Boehringer Ingelheim Investigational Site, San Antonio, Texas, United States

202.839.01007 Boehringer Ingelheim Investigational Site, Virginia Beach, Virginia, United States

202.839.01020 Boehringer Ingelheim Investigational Site, Milwaukee, Wisconsin, United States

Additional Information

Starting date: June 2009
Last updated: April 30, 2014

Page last updated: August 23, 2015

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