The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks
Change from baseline in symptoms associated with diabetic gastroparesis
Time frame: 12 Weeks
Change from baseline in health-related quality of life
Time frame: 12 Weeks
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
Time frame: 12 Weeks
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Huntsville, Alabama, United States
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Tucson, Arizona, United States
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North Little Rock, Arkansas, United States
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Long Beach, California, United States
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Ventura, California, United States
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Hialeah, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
...and 25 more locations