Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Milwaukee, Wisconsin


Purpose:

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 summary:

See approved Package Insert for Adverse Event information.


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


NCT ID:

NCT00139893


Primary Contact:

Study Director
Patricia Witt
UCB, Inc.


Backup Contact:

N/A


Location Contact:

Milwaukee, Wisconsin
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.