Status:
COMPLETED
A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis
Lead Sponsor:
UCB Pharma
Conditions:
Diabetic Gastroparesis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is metabolized faster than the conventional Reglan tablet in patients with diabetic gastroparesis, pharmacokinetics f...
Detailed Description
See approved Package Insert for Adverse Event information.
Eligibility Criteria
Inclusion
- Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis
Exclusion
- Serum glucose \>300 mg/dL, HbA1C \>10%, and concurrent illness interfering with gastrointestinal motility
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00139893
Start Date
June 1 2005
Last Update
March 26 2013
Active Locations (1)
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1
Schwarz
Milwaukee, Wisconsin, United States