Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying - Full Text View

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

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
Placebo Comparator: 1	Drug: placebo Placebo tablet taken by mouth once a day for 8 weeks
Active Comparator: 2 5 mg tadalafil	Drug: tadalafil 5 mg tadalafil tablet taken by mouth once a day for 8 weeks Other Names: LY450190 Cialis IC351
Active Comparator: 3 20 mg tadalafil	Drug: tadalafil 20 mg tadalafil tablet taken by mouth once a day for 8 weeks Other Names: LY450190 Cialis IC351

Eligibility


Ages Eligible for Study:	18 Years to 69 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
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

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


ClinicalTrials.gov Identifier:	NCT00050609 History of Changes
Other Study ID Numbers:	4979 H6D-MC-LVDC
Study First Received:	December 16, 2002
Last Updated:	November 16, 2007

Additional relevant MeSH terms:


Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Signs and Symptoms	Tadalafil Vasodilator Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents

ClinicalTrials.gov processed this record on May 25, 2017