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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 Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Gastroparesis

Intervention: Reglan ODT (Drug)

Phase: N/A

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
Patricia Witt, Study Director, Affiliation: UCB Pharma

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: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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: March 25, 2013

Page last updated: August 23, 2015

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