Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Gastroparesis

In brief

Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.

Key facts

Study ID

NCT02187094

Run by

Targacept Inc.

People needed

80

Starts

2014-06-01

Expected to finish

2015-01-01

Last updated by the study team

2015-05-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score >22)
• Gastroparesis confirmed using the GEBT
• Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%
• Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT
• Body Mass Index (BMI) ≤ 40
• Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures
• Willingness to use a double barrier method of birth control (except post-menopausal females)
• Able to understand study procedures and provide written informed consent

You may not qualify if…

• History of abdominal surgery including gastric banding procedure
• Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube
• Persistent daily vomiting
• A history of eating disorder
• Recent history of poor control of diabetes
• Acute severe gastroenteritis
• Have implanted or use any type of gastric electric stimulator
• Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs
• Use of medications potentially influencing upper gastrointestinal motility or appetite
• Allergies or intolerance to egg, wheat, milk, or algae
• Pregnant or lactating females
• Presence of a clinically significant medical condition at any time during the study
• Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
• Participated in an investigational drug study within 30 days of screening

Where it is running

• Horizon Research Group, Inc. — Mobile, Alabama, United States
• Prefered Research Partners, Inc. — Little Rock, Arkansas, United States
• Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
• Ventura Clinical Trials — Ventura, California, United States
• Wake Research associates, LLC — Raleigh, North Carolina, United States
• ClinSearch, LLC — Chattanooga, Tennessee, United States
• Quality Medical Research — Nashville, Tennessee, United States
• Aspen Clinical Research, LLC — Orem, Utah, United States

Full record on ClinicalTrials.gov

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