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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

Sponsor
UCB Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00139893
Collaborator
(none)
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Reglan ODT
 N/A

Detailed Description

See approved Package Insert for Adverse Event information.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Oct 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Schwarz Milwaukee Wisconsin United States

    Sponsors and Collaborators

    • UCB Pharma

    Investigators

    • Study Director: Patricia Witt, UCB Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCB Pharma
    ClinicalTrials.gov Identifier:
    NCT00139893
    Other Study ID Numbers:
    • SP850
    First Posted:
    Aug 31, 2005
    Last Update Posted:
    Mar 26, 2013
    Last Verified:
    May 1, 2008
    Additional relevant MeSH terms:
    Gastroparesis
    Metoclopramide

    Study Results

    No Results Posted as of Mar 26, 2013