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.

First Received: August 29, 2005 Last Updated: May 16, 2008 History of Changes

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

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

Resource links provided by NLM:

Drug Information available for: Metoclopramide hydrochloride Metoclopramide

U.S. FDA Resources

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

No publications provided

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

Study placed in the following topic categories:

Neurotransmitter Agents
Gastrointestinal Diseases
Antiemetics
Metoclopramide
Paralysis
Signs and Symptoms
Stomach Diseases

Digestive System Diseases
Dopamine
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Gastroparesis

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Dopamine Antagonists
Metoclopramide
Pharmacologic Actions
Paralysis

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Autonomic Agents
Therapeutic Uses
Neurologic Manifestations
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastroparesis

ClinicalTrials.gov processed this record on July 02, 2009