NCT00139893

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

March 26, 2013

Status Verified

May 1, 2008

Enrollment Period

4 months

First QC Date

August 29, 2005

Last Update Submit

March 25, 2013

Conditions

Diabetic Gastroparesis

Interventions

Reglan ODTDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis

You may not qualify if:

  • Serum glucose \>300 mg/dL, HbA1C \>10%, and concurrent illness interfering with gastrointestinal motility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schwarz

Milwaukee, Wisconsin, United States

Location

Study Officials

  • Patricia Witt

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

June 1, 2005

Primary Completion

October 1, 2005

Last Updated

March 26, 2013

Record last verified: 2008-05

Locations

US(1)