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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00139893

First received: August 29, 2005

Last updated: March 25, 2013

Last verified: May 2008

History of Changes

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.

Condition	Intervention
Diabetic Gastroparesis	Drug: Reglan ODT


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Metoclopramide Metoclopramide hydrochloride

U.S. FDA Resources

Further study details as provided by UCB Pharma:


Study Start Date:	June 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Detailed Description:

See approved Package Insert for Adverse Event information.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139893

Locations


United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	Patricia Witt	UCB Pharma

More Information

No publications provided


Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT00139893 History of Changes
Other Study ID Numbers:	SP850
Study First Received:	August 29, 2005
Last Updated:	March 25, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations	Paralysis Signs and Symptoms Stomach Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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