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Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying
This study has been completed.
First Received: December 16, 2002   Last Updated: November 16, 2007   History of Changes
Sponsor: Eli Lilly and Company
Collaborator: ICOS Corporation
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00050609
  Purpose

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


Condition Intervention Phase
Gastroparesis
 Drug: tadalafil
Drug: placebo
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis

Resource links provided by NLM:

MedlinePlus related topics: Indigestion Nausea and Vomiting
Drug Information available for: Tadalafil
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: February 2003
Study Completion Date: September 2003
Arms Assigned Interventions
1: Placebo Comparator Drug: placebo
Placebo tablet taken by mouth once a day for 8 weeks
2: Active Comparator
5 mg tadalafil
Drug: tadalafil
5 mg tadalafil tablet taken by mouth once a day for 8 weeks
3: Active Comparator
20 mg tadalafil
Drug: tadalafil
20 mg tadalafil tablet taken by mouth once a day for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050609

Locations
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.
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.
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.
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.
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.
Sainte-Foy, 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.
Montreal, 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
Sponsors and Collaborators
Eli Lilly and Company
ICOS Corporation
Investigators
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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 4979, H6D-MC-LVDC
Study First Received: December 16, 2002
Last Updated: November 16, 2007
ClinicalTrials.gov Identifier: NCT00050609     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paralysis
Signs and Symptoms
Phosphodiesterase Inhibitors
Digestive System Diseases
Stomach Diseases
Molecular Mechanisms of Pharmacological Action
 Gastrointestinal Diseases
Tadalafil
Neurologic Manifestations
Enzyme Inhibitors
Pharmacologic Actions
Gastroparesis

ClinicalTrials.gov processed this record on November 09, 2009



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