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Last Updated: October 19, 2019

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CLINICAL TRIALS PROFILE FOR REGLAN ODT

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Clinical Trials for Reglan Odt

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000654 The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU Completed Oclassen Pharmaceuticals Phase 2 1969-12-31 To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00000654 The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00139893 A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to ReglanĀ® Tablets in Subjects With Diabetic Gastroparesis Completed UCB Pharma N/A 2005-06-01 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 ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Reglan Odt

Condition Name

Condition Name for Reglan Odt
Intervention Trials
Gastroparesis 3
Diabetic Gastroparesis 2
Headache 2
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Condition MeSH

Condition MeSH for Reglan Odt
Intervention Trials
Headache 10
Migraine Disorders 8
Emergencies 5
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Clinical Trial Locations for Reglan Odt

Trials by Country

Trials by Country for Reglan Odt
Location Trials
United States 57
Nepal 1
Canada 1
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Trials by US State

Trials by US State for Reglan Odt
Location Trials
New York 7
Pennsylvania 4
Tennessee 3
California 3
North Carolina 3
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Clinical Trial Progress for Reglan Odt

Clinical Trial Phase

Clinical Trial Phase for Reglan Odt
Clinical Trial Phase Trials
Phase 4 10
Phase 3 5
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Reglan Odt
Clinical Trial Phase Trials
Completed 14
Recruiting 6
Terminated 3
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Clinical Trial Sponsors for Reglan Odt

Sponsor Name

Sponsor Name for Reglan Odt
Sponsor Trials
Montefiore Medical Center 3
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2
Children's Hospital of Michigan 1
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Sponsor Type

Sponsor Type for Reglan Odt
Sponsor Trials
Other 35
NIH 4
Industry 3
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