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.

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00139893

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

Drug Information available for: Metoclopramide Metoclopramide hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment
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

Further study details as provided by UCB:

Study Start Date:	June 2005
Estimated 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

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

Locations

United States, Wisconsin
Schwarz
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

Patricia Witt

UCB

More Information

Study ID Numbers:	SP850
Study First Received:	August 29, 2005
Last Updated:	May 16, 2008
ClinicalTrials.gov Identifier:	NCT00139893
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Paralysis
Signs and Symptoms
Dopamine
Digestive System Diseases
Stomach Diseases

Gastrointestinal Diseases
Neurologic Manifestations
Metoclopramide
Gastroparesis

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents

Antiemetics
Dopamine Agents
Dopamine Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009