YM443 in Subjects With Functional Dyspepsia

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.