Status:
COMPLETED
Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
Lead Sponsor:
Targacept Inc.
Conditions:
Gastroparesis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 st...
Detailed Description
This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. Duri...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02187094
Start Date
June 1 2014
End Date
January 1 2015
Last Update
May 12 2015
Active Locations (8)
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1
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
2
Prefered Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
3
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
4
Ventura Clinical Trials
Ventura, California, United States, 93003