Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
416 participants
INTERVENTIONAL
2004-03-10
2006-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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YM443
Eligibility Criteria
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Inclusion Criteria
* Written informed consent has been obtained.
* 18-75 years of age on the day the Informed Consent Form is signed.
* Men or women.
* Females, not pregnant, lactating or likely to become pregnant.
* Abdominal ultrasound and/or upper endoscopy findings that are judged as not clinically significant by the Investigator during Screening or within 4 weeks prior to Screening.
* Symptoms of FD at Visits 1 and 4 as defined by Rome II criteria.
* Subjects with a positive H. pylori breath test at Screening may be included in the study.
* Subjects with pH-metry results at Screening indicative of reflux may be included in the study.
* ECG, vital signs, and laboratory results that are judged as not clinically significant by the Investigator during Screening.
Exclusion Criteria
* Subjects with diabetes mellitus are to be excluded.
* Congenital or acquired long QT syndrome, or uncontrolled arrhythmias.
* Prior surgery on the luminal GI tract.
* History of any major psychiatric disorder, current depression or anxiety, alcohol abuse, or substance abuse in the last 2 years.
* Any evidence or treatment for malignancy (with the exception of basal cell carcinoma) within the last 5 years.
* Confirmed structural gastrointestinal disease.
* Predominant symptoms of irritable bowel syndrome (IBS) (Rome II criteria) or gastroesophageal reflux disease (GERD) assessed at Visit 1 or 4.
* Female subjects who are pregnant, lactating, or are likely to become pregnant during the study.
* Males and females of child-bearing potential must be abstinent or agree to use contraceptive regimens throughout the study.
* Any history or condition which, in the opinion of the Investigator, makes the subject unsuitable for any of the procedures used during this study or would not allow for safe completion of the study.
* Known hypersensitivity to gastroprokinetics or proton pump inhibitors.
* Use of anti-ulcer medications, antacid/acid suppression medications, gastroprokinetics, aspirin (\>325 mg daily), other NSAIDs, antibiotics, and other medications that effect the GI system within 2 weeks prior to Screening. Must be able to stay off these medications during the study, except for proton pump inhibitors (PPIs) administered during the PPI Run-in Period.
* Required use of concomitant medications known to adversely interact with other gastroprokinetic agents or proton pump inhibitors.
* H. pylori eradication therapy (PPIs, antibiotics, bismuth preparations) in the 2 weeks prior to the upper endoscopy.
* Treatment for H. pylori required during the study.
* Subject has received an investigational drug within 30 days or 10 half-lives, which ever is longer, or participated in more than 3 clinical studies within 12 months, prior to Visit 1.
* Previous treatment with YM443.
* Employees of the Yamanouchi Group or CROs involved in the study.
* More than one subject per household to participate in the study.
18 Years
75 Years
ALL
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
APUS
Locations
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Dr. Suresh Karne
Huntsville, Alabama, United States
James Thrasher, MD
Little Rock, Arkansas, United States
Dr. Dennis Riff
Anaheim, California, United States
Dr. Peter Winkle
Cypress, California, United States
Dr. Ramin Farsad
Encinitas, California, United States
Dr. Prahalad Jajodia
Fresno, California, United States
Dr. Gurmej Dhillon
Fresno, California, United States
Dr. Steven Duckor
Orange, California, United States
Dr. Theodor Feinstat
Roseville, California, United States
Scott Levenson, MD
San Carlos, California, United States
Dr. Michael Bennett
San Diego, California, United States
Dr. William Snape
San Francisco, California, United States
Dr. Abbass Shafii
Colorado Springs, Colorado, United States
Dr. Julio Salcedo
Washington D.C., District of Columbia, United States
Dr. Daniel Maico
Gainesville, Florida, United States
Dr. Simon Behar
Hialeah, Florida, United States
Wayne Schonfeld, MD
Hollywood, Florida, United States
Dr. Stephen Palte
Atlanta, Georgia, United States
Dr. Nathan Segall
Atlanta, Georgia, United States
Azazuddin Ahmed, MD
Oak Brook, Illinois, United States
Brian Covey, MD
Dubuque, Iowa, United States
Dr. Richard McCallum
Kansas City, Kansas, United States
Robert Braun, MD
Topeka, Kansas, United States
Carroll Steinfeld, MD
Madisonville, Kentucky, United States
David Dulitz, MD
Metairie, Louisiana, United States
Dr. Bal Raj Bhandari
Monroe, Louisiana, United States
Dr. Robert Hardi
Chevy Chase, Maryland, United States
Dr. Braden Kuo
Boston, Massachusetts, United States
Dr. Robert Lustig
Bridgewater, New Jersey, United States
Dr. Rejendra Prasad Gupta
Trenton, New Jersey, United States
Dr. Vitaly Fishbein
West Orange, New Jersey, United States
Dr. Wieslaw Ignatowicz
Brooklyn, New York, United States
Dr. Eugene Bonapace
Great Neck, New York, United States
Dr. James Grendell
Mineola, New York, United States
Dr. William Harlan
Asheville, North Carolina, United States
Dr. John Poulos
Fayetteville, North Carolina, United States
Dr. Peter Eweje
Jacksonville, North Carolina, United States
Dr. Charles Barish
Raleigh, North Carolina, United States
Dr. William Gramley
Wilmington, North Carolina, United States
Dr. Robert Kindel
Cincinnati, Ohio, United States
Dr. Gregory Cooper
Cleveland, Ohio, United States
Dr. Gary Falk
Cleveland, Ohio, United States
Dr. Michael Grossman
Oklahoma City, Oklahoma, United States
Michael Mirhej, MD
Eugene, Oregon, United States
Dr. Nayan Shah
Eynon, Pennsylvania, United States
Dr. Robert Fisher
Philadelphia, Pennsylvania, United States
Dr. Cynthia Strout
Mt. Pleasant, South Carolina, United States
Robert Smith, MD
Saluda, South Carolina, United States
Dr. Richard Krause
Chattanooga, Tennessee, United States
Dr. Mark Swaim
Jackson, Tennessee, United States
George James, MD
Nashville, Tennessee, United States
Dr. Ronald Pruitt
Nashville, Tennessee, United States
Dr. James Race
Dallas, Texas, United States
Sardar Khan, MD
Houston, Texas, United States
Ralph Alhalel, MD
McAllen, Texas, United States
Dr. Daniel Pambianco
Charlottesville, Virginia, United States
Dr. Mark Ringold
Christiansburg, Virginia, United States
Vinod Rustgi, MD
Fairfax, Virginia, United States
Dr. Michael Schmalz
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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443-CL-008
Identifier Type: -
Identifier Source: org_study_id
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