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...
Date First Received: August 29, 2005
Last Updated: May 16, 2008
Verified by: UCB, May 2008
Clinical Trial Phase: N/A | Start Date: June 2005
Overall Status: Completed
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment
Study Primary Completion Date: October 2005
Detailed Clinical Trial Description
See approved Package Insert for Adverse Event information.
Intervention(s) in this Clinical Trial
- Drug: Reglan ODT
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: UCB
Overall Clinical Trial Officials and Contacts
Patricia Witt Study Director UCB
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139893
Study ID Number: SP850
ClinicalTrials.gov Identifier: NCT00139893
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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