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

NCT ID: NCT00932737

Last Updated: 2022-05-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-09

Study Completion Date

2010-02-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Hyoscine butylbromide (HBB) 20mg 1-5 tablets per episode

Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode

Group Type ACTIVE_COMPARATOR

HBB 20 mg

Intervention Type DRUG

Active drug, one to five tablets per episode

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1-5 tablets per episode

Interventions

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Placebo

1-5 tablets per episode

Intervention Type DRUG

HBB 20 mg

Active drug, one to five tablets per episode

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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202.839.01014 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Site Status

202.839.01003 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Site Status

202.839.01001 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Site Status

202.839.01002 Boehringer Ingelheim Investigational Site

Jupiter, Florida, United States

Site Status

202.839.01017 Boehringer Ingelheim Investigational Site

Rockford, Illinois, United States

Site Status

202.839.01005 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Site Status

202.839.01019 Boehringer Ingelheim Investigational Site

Chevy Chase, Maryland, United States

Site Status

202.839.01009 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Site Status

202.839.01004 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Site Status

202.839.01011 Boehringer Ingelheim Investigational Site

Toms River, New Jersey, United States

Site Status

202.839.01008 Boehringer Ingelheim Investigational Site

Lake Success, New York, United States

Site Status

202.839.01015 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

202.839.01021 Boehringer Ingelheim Investigational Site

Norman, Oklahoma, United States

Site Status

202.839.01010 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

202.839.01013 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

202.839.01006 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

202.839.01012 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

202.839.01007 Boehringer Ingelheim Investigational Site

Virginia Beach, Virginia, United States

Site Status

202.839.01020 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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U09-3181-01

Identifier Type: -

Identifier Source: secondary_id

202.839

Identifier Type: -

Identifier Source: org_study_id

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