Back to resultsA 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
Primary Purpose
Diabetic Gastroparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reglan ODT
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis
Eligibility 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
Sites / Locations
- Schwarz
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139893
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
5. 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.
Detailed Description
See approved Package Insert for Adverse Event information.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Reglan ODT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Witt
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Schwarz
City
Milwaukee
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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