Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying
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ClinicalTrials.gov Identifier: NCT00050609 |
Recruitment Status :
Completed
First Posted : December 18, 2002
Last Update Posted : November 20, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastroparesis | Drug: tadalafil Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis |
Study Start Date : | February 2003 |
Actual Study Completion Date : | September 2003 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1 |
Drug: placebo
Placebo tablet taken by mouth once a day for 8 weeks |
Active Comparator: 2
5 mg tadalafil
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Drug: tadalafil
5 mg tadalafil tablet taken by mouth once a day for 8 weeks
Other Names:
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Active Comparator: 3
20 mg tadalafil
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Drug: tadalafil
20 mg tadalafil tablet taken by mouth once a day for 8 weeks
Other Names:
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- Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo [ Time Frame: 8 weeks ]
- Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 20 mg tadalafil compared to placebo [ Time Frame: 8 weeks ]
- Measure of change from baseline to endpoint using the Visual Analog Score and Nepean Dyspepsia Index Symptom Checklist in patients taking 5 mg tadalafil, 20 mg tadalafil and placebo [ Time Frame: 8 weeks ]

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of diabetes mellitus
- Delayed gastric emptying
- 3 month minimum history of chronic 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 and history of certain heart problems

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050609
Canada, Alberta | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Edmonton, Alberta, Canada | |
Canada, British Columbia | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Vancouver, British Columbia, Canada | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Victoria, British Columbia, Canada | |
Canada, Manitoba | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Winnipeg, Manitoba, Canada | |
Canada, Ontario | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Courtice, Ontario, Canada | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Hamilton, Ontario, Canada | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Kitchener, Ontario, Canada | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
London, Ontario, Canada | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Ottawa, Ontario, Canada | |
Canada, Quebec | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Montreal, Quebec, Canada | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Sainte-Foy, Quebec, Canada | |
Canada, Saskatchewan | |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
Saskatoon, Saskatchewan, Canada |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00050609 |
Other Study ID Numbers: |
4979 H6D-MC-LVDC |
First Posted: | December 18, 2002 Key Record Dates |
Last Update Posted: | November 20, 2007 |
Last Verified: | November 2007 |
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Tadalafil |
Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |