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
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Gastroparesis
Intervention: Reglan ODT (Drug)
Phase: N/A
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Patricia Witt, Study Director, Affiliation: UCB
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 following a single 10 mg dose of each formulation are being
compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented
gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each
dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent
illness interfering with gastrointestinal motility. Subjects will stay in the clinic
overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning
dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve
(AUC) from time zero to 8 hr will be compared for the 2 formulations.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment
Detailed description:
See approved Package Insert for Adverse Event information.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis
Exclusion Criteria:
- Serum glucose >300 mg/dL, HbA1C >10%, and concurrent illness interfering with
gastrointestinal motility
Locations and Contacts
Schwarz, Milwaukee, Wisconsin, United States
Additional Information
Starting date: June 2005
Last updated: May 16, 2008
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