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.

Condition	Treatment or Intervention	Phase
Indigestion Nausea	Drug: YM443	Phase II

Further Study Details: 

Expected Total Enrollment:  400

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Alabama
      Dr. Suresh Karne, Huntsville,  Alabama,  35802,  United States; Recruiting
California
      Dr. Michael Bennet, San Diego,  California,  92123,  United States; Recruiting
      Dr. Gurmej Dhillon, Fresno,  California,  93710,  United States; Recruiting
      Dr. Steven Duckor, Orange,  California,  92869,  United States; Recruiting
      Dr. Ramin Farsad, Encinitas,  California,  92024,  United States; Recruiting
      Dr. Theodor Feinstat, Roseville,  California,  95661,  United States; Recruiting
      Dr. Prahalad Jajodia, Fresno,  California,  93703,  United States; Recruiting
      Dr. Dean Rider, San Francisco,  California,  94117,  United States; Recruiting
      Dr. Dennis Riff, Anaheim,  California,  92801,  United States; Recruiting
      Dr. Herbert Rubin, Los Angeles,  California,  90067,  United States; Recruiting
      Dr. William Snape, San Francisco,  California,  94115,  United States; Recruiting
      Dr. Gregory Wiener, Chula Vista,  California,  91910,  United States; Recruiting
      Dr. Peter Winkle, Cypress,  California,  90630,  United States; Recruiting
Colorado
      Dr. Abbass Shafii, Colorado Springs,  Colorado,  80909,  United States; Recruiting
District of Columbia
      Dr. Julio Salcedo, Washington,  District of Columbia,  20010,  United States; Recruiting
Florida
      Dr. Simon Behar, Hialeah,  Florida,  33013,  United States; Recruiting
      Dr. Daniel Maico, Gainesville,  Florida,  32605,  United States; Recruiting
      Dr. Jeffrey Schneider, Plantation,  Florida,  33324,  United States; Recruiting
Georgia
      Dr. Stephen Palte, Atlanta,  Georgia,  30339,  United States; Recruiting
      Dr. Nathan Segall, Atlanta,  Georgia,  30342,  United States; Recruiting
Kansas
      Dr. Luis Angles, Shawnee Mission,  Kansas,  66216,  United States; Recruiting
      Dr. Richard McCallum, Kansas City,  Kansas,  66160,  United States; Recruiting
Louisiana
      Dr. Bal Raj Bhandari, Monroe,  Louisiana,  71201,  United States; Recruiting
Maryland
      Dr. Robert Hardi, Chevy Chase,  Maryland,  20815,  United States; Recruiting
Massachusetts
      Dr. Braden Kuo, Boston,  Massachusetts,  02114,  United States; Recruiting
New Jersey
      Dr. Vitaly Fishbein, West Orange,  New Jersey,  07052,  United States; Recruiting
      Dr. Robert Lustig, Bridgewater,  New Jersey,  08807,  United States; Recruiting
      Dr. Rejendra Prasad Gupta, Trenton,  New Jersey,  08618,  United States; Recruiting
New York
      Dr. Eugene Bonapace, Great Neck,  New York,  11021,  United States; Recruiting
      Dr. James Grendell, Mineola,  New York,  11501,  United States; Recruiting
      Dr. Wieslaw Ignatowicz, Brooklyn,  New York,  11222,  United States; Recruiting
North Carolina
      Dr. Charles Barish, Raleigh,  North Carolina,  27812,  United States; Recruiting
      Dr. Peter Eweje, Jacksonville,  North Carolina,  28546,  United States; Recruiting
      Dr. William Gramley, Wilmington,  North Carolina,  28401,  United States; Recruiting
      Dr. William Harlan, Asheville,  North Carolina,  28801,  United States; Recruiting
      Dr. John Poulos, Fayetteville,  North Carolina,  28304,  United States; Recruiting
Ohio
      Dr. Gregory Cooper, Cleveland,  Ohio,  44106,  United States; Recruiting
      Dr. Gary Falk, Cleveland,  Ohio,  44195,  United States; Recruiting
      Dr. Robert Kindel, Cincinnati,  Ohio,  45220,  United States; Recruiting
Oklahoma
      Dr. Michael Grossman, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Dr. Phillip Miner, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Pennsylvania
      Dr. Robert Fisher, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
      Dr. Nayan Shah, Eynon,  Pennsylvania,  18403,  United States; Recruiting
South Carolina
      Dr. Cynthia Strout, Mt. Pleasant,  South Carolina,  29464,  United States; Recruiting
Tennessee
      Dr. Richard Krause, Chattanooga,  Tennessee,  37404,  United States; Recruiting
      Dr. Ronald Pruitt, Nashville,  Tennessee,  37205,  United States; Recruiting
      Dr. Mark Swaim, Jackson,  Tennessee,  38305,  United States; Recruiting
Texas
      Dr. Frank Martinez, Corpus Christi,  Texas,  78411,  United States; Recruiting
      Dr. James Race, Dallas,  Texas,  75224,  United States; Recruiting
Virginia
      Dr. Daniel Pambianco, Charlottesville,  Virginia,  22911,  United States; Recruiting
      Dr. Mark Ringold, Christiansburg,  Virginia,  24073,  United States; Recruiting
Wisconsin
      Dr. Michael Schmalz, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study ID Numbers:  443-CL-008
Record last reviewed:  January 2005
Last Updated:  January 26, 2005
Record first received:  January 26, 2005
ClinicalTrials.gov Identifier:  NCT00102310
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08