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NCT00139893 · ClinicalTrials.gov registry record · NA
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
A NA study, sponsored by UCB Pharma.
- Completed
- Registry status
- NA
- Development phase
NCT00139893: Completed NA study, sponsored by UCB Pharma.
NCT00139893 is a NA study that has completed, run by UCB Pharma. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00139893, a NA study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- NA
- Development phase
Study 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.
Interventions
- DRUG Reglan ODT
Trial Details
| Field | Value |
|---|---|
| Start Date | 2005-06 |
| Phase | NA |
What the finished NCT00139893 record still lists
NCT00139893 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which Reglan ODT is the first listed.
NCT00139893 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00139893 about?
NCT00139893 is a clinical study titled "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". 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, h...
What is the current status of trial NCT00139893?
This trial is currently completed. It is a NA study. The study started on 2005-06.
What interventions are being tested in trial NCT00139893?
The interventions under investigation include: Reglan ODT (DRUG).
Who is sponsoring clinical trial NCT00139893?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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