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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00139893
Other study ID # SP850
Secondary ID
Status Completed
Phase N/A
First received August 29, 2005
Last updated March 25, 2013
Start date June 2005

Study information

Verified date May 2008
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

See approved Package Insert for Adverse Event information.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Reglan ODT


Locations

Country Name City State
United States Schwarz Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

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