YM443 in Subjects With Functional Dyspepsia
- Conditions
- NauseaIndigestion
- Registration Number
- NCT00102310
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The primary objective of this study will be to characterize the dose response profile of YM443 in subjects with functional dyspepsia (FD) to enable the selection of doses for the Phase 3 clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- Ability to read and write in English.
- 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.
- Significant renal, hepatic, bilirubin, cardiovascular, pulmonary, endocrine, metabolic, hematological, neurologic, or gastrointestinal (other than the one being studied) condition.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Dr. Michael Bennett
🇺🇸San Diego, California, United States
Dr. William Snape
🇺🇸San Francisco, California, United States
Dr. Braden Kuo
🇺🇸Boston, Massachusetts, United States
Dr. Robert Kindel
🇺🇸Cincinnati, Ohio, United States
Dr. Gary Falk
🇺🇸Cleveland, Ohio, United States
Dr. Michael Grossman
🇺🇸Oklahoma City, Oklahoma, United States
Dr. Ronald Pruitt
🇺🇸Nashville, Tennessee, United States
James Thrasher, MD
🇺🇸Little Rock, Arkansas, United States
Dr. Suresh Karne
🇺🇸Huntsville, Alabama, United States
Dr. Ramin Farsad
🇺🇸Encinitas, California, United States
Dr. Dennis Riff
🇺🇸Anaheim, California, United States
Wayne Schonfeld, MD
🇺🇸Hollywood, Florida, United States
Azazuddin Ahmed, MD
🇺🇸Oak Brook, Illinois, United States
Dr. Richard McCallum
🇺🇸Kansas City, Kansas, United States
Dr. Gurmej Dhillon
🇺🇸Fresno, California, United States
Dr. James Grendell
🇺🇸Mineola, New York, United States
Dr. John Poulos
🇺🇸Fayetteville, North Carolina, United States
Dr. Peter Eweje
🇺🇸Jacksonville, North Carolina, United States
Dr. Gregory Cooper
🇺🇸Cleveland, Ohio, United States
Dr. Cynthia Strout
🇺🇸Mount Pleasant, South Carolina, United States
Dr. James Race
🇺🇸Dallas, Texas, United States
Dr. Peter Winkle
🇺🇸Cypress, 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. Abbass Shafii
🇺🇸Colorado Springs, Colorado, United States
Dr. Julio Salcedo
🇺🇸Washington, District of Columbia, United States
Robert Braun, MD
🇺🇸Topeka, Kansas, United States
Dr. Bal Raj Bhandari
🇺🇸Monroe, Louisiana, United States
Brian Covey, MD
🇺🇸Dubuque, Iowa, United States
David Dulitz, MD
🇺🇸Metairie, Louisiana, United States
Carroll Steinfeld, MD
🇺🇸Madisonville, Kentucky, United States
Dr. Robert Hardi
🇺🇸Chevy Chase, Maryland, 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. Eugene Bonapace
🇺🇸Great Neck, New York, United States
Dr. William Harlan
🇺🇸Asheville, North Carolina, United States
Dr. William Gramley
🇺🇸Wilmington, North Carolina, United States
Dr. Charles Barish
🇺🇸Raleigh, North Carolina, United States
Michael Mirhej, MD
🇺🇸Eugene, Oregon, United States
Dr. Nayan Shah
🇺🇸Eynon, Pennsylvania, United States
George James, MD
🇺🇸Nashville, Tennessee, United States
Sardar Khan, MD
🇺🇸Houston, Texas, United States
Dr. Richard Krause
🇺🇸Chattanooga, Tennessee, United States
Dr. Mark Swaim
🇺🇸Jackson, Tennessee, United States
Dr. Daniel Pambianco
🇺🇸Charlottesville, Virginia, United States
Ralph Alhalel, MD
🇺🇸McAllen, Texas, United States
Dr. Mark Ringold
🇺🇸Christiansburg, Virginia, United States
Dr. Robert Fisher
🇺🇸Philadelphia, Pennsylvania, United States
Vinod Rustgi, MD
🇺🇸Fairfax, Virginia, United States
Robert Smith, MD
🇺🇸Saluda, South Carolina, United States
Dr. Simon Behar
🇺🇸Hialeah, Florida, United States
Dr. Wieslaw Ignatowicz
🇺🇸Brooklyn, New York, United States
Dr. Stephen Palte
🇺🇸Atlanta, Georgia, United States
Dr. Nathan Segall
🇺🇸Atlanta, Georgia, United States
Dr. Prahalad Jajodia
🇺🇸Fresno, California, United States
Dr. Michael Schmalz
🇺🇸Milwaukee, Wisconsin, United States
Dr. Daniel Maico
🇺🇸Gainesville, Florida, United States