The purposes of this study are to determine whether an experimental drug known as IC351 (tadalafil) can reduce symptoms of dyspepsia in diabetic patients (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting), and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of IC351 given once daily for 8 weeks in this population will also be studied.

Condition	Treatment or Intervention
Gastroparesis	Drug: Investigational drug (IC351, tadalafil)

Further Study Details: 

Ages Eligible for Study:  18 Years   -   69 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of diabetes mellitus
• Delayed gastric emptying
• History of upper abdominal discomfort
• Symptoms of dyspepsia (upset stomach)

Exclusion Criteria:

• Major gastrointestinal surgery or medical conditions known to affect gastric motility
• Irritable Bowl Syndrome
• Medications known to affect gastric motility
• Angina treated with nitrates
• Uncontrolled diabetes mellitus

Canada, Alberta
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Edmonton,  Alberta,  Canada
Canada, British Columbia
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Vancouver,  British Columbia,  Canada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Victoria,  British Columbia,  Canada
Canada, Manitoba
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Winnipeg,  Manitoba,  Canada
Canada, Ontario
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Courtice,  Ontario,  Canada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., London,  Ontario,  Canada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Kitchener,  Ontario,  Canada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Hamilton,  Ontario,  Canada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Ottawa,  Ontario,  Canada
Canada, Quebec
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Sainte-Foy,  Quebec,  Canada
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Montreal,  Quebec,  Canada
Canada, Saskatchewan
      "For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician"., Saskatoon,  Saskatchewan,  Canada

Study ID Numbers:  4979
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  December 16, 2002
ClinicalTrials.gov Identifier:  NCT00050609
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08