CLINICAL TRIALS PROFILE FOR REGLAN ODT

All Clinical Trials for REGLAN ODT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00139893 ↗	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	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.
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.

Clinical Trial Conditions for REGLAN ODT

Condition Name

Condition Name for REGLAN ODT
Intervention	Trials
Gastroparesis	3
Diabetic Gastroparesis	2
Anesthesia	2

Condition MeSH

Condition MeSH for REGLAN ODT
Intervention	Trials
Headache	11
Migraine Disorders	8
Vomiting	5

Clinical Trial Locations for REGLAN ODT

Trials by Country

+

−

Trials by Country for REGLAN ODT
Location	Trials
United States	60
Nepal	1
India	1
Canada	1

Trials by US State

+

−

Trials by US State for REGLAN ODT
Location	Trials
New York	8
Pennsylvania	4
Tennessee	3
California	3
North Carolina	3

Clinical Trial Progress for REGLAN ODT

Clinical Trial Phase

Clinical Trial Phase for REGLAN ODT
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for REGLAN ODT
Clinical Trial Phase	Trials
Completed	18
Unknown status	5
Terminated	4

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
Women and Infants Hospital of Rhode Island	2

Sponsor Type

Sponsor Type for REGLAN ODT
Sponsor	Trials
Other	43
NIH	4
Industry	3

Reglan ODT: Clinical Trials, Market Analysis, and Projections

Introduction to Reglan ODT

Reglan ODT, or Metoclopramide Orally Disintegrating Tablets, is a medication used to treat various gastrointestinal conditions. It acts as a dopamine-2 (D2) antagonist, making it effective for conditions such as gastroesophageal reflux disease (GERD) and acute or recurrent diabetic gastroparesis[2].

Clinical Uses of Reglan ODT

Reglan ODT is indicated for the treatment of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy, as well as for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. It is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms[1].

Dosage and Administration

The recommended adult dosage of Reglan ODT is 10 to 15 mg four times daily for 4 to 12 weeks. The dosage should be administered 30 minutes before each meal and at bedtime, with a maximum recommended daily dosage of 60 mg. Special considerations are necessary for patients with hepatic or renal impairment, as well as for those who are CYP2D6 poor metabolizers or using strong CYP2D6 inhibitors[1].

Clinical Trials Overview

Several clinical trials have been conducted to evaluate the efficacy and safety of Reglan ODT and its counterparts.

Efficacy in Diabetic Gastroparesis

A dose-ranging Phase 2b clinical trial conducted by Evoke Pharma involved 287 male and female subjects with diabetic gastroparesis. The trial showed that doses of 10 mg and 14 mg of Gimoti (a nasal formulation of metoclopramide) were effective in improving symptoms associated with gastroparesis, particularly in women. The trial demonstrated statistically significant improvements in nausea and upper abdominal pain over 28 days[4].

Comparative Exposure PK Trial

A comparative exposure pharmacokinetic (PK) trial was conducted to compare the bioequivalence of Gimoti with Reglan Tablets. The trial involved 108 healthy male and female volunteers and showed that two of the three tested doses of Gimoti met the dose selection criteria for bioequivalence. The study also highlighted sex-based differences in exposure, with women showing higher AUC values compared to men[4].

Safety and Efficacy in Endoscopy

A double-blind, randomized, placebo-controlled trial evaluated the safety and effects of metoclopramide ODT versus traditional tablets (TT) and placebo in non-fasting patients undergoing outpatient endoscopy. The study found that metoclopramide ODT had fewer adverse events and significantly shorter recovery times compared to TT and placebo[5].

Market Analysis

Current Market Position

Reglan ODT is a well-established medication in the market for treating GERD and diabetic gastroparesis. Its orally disintegrating formulation offers convenience and better tolerability compared to traditional tablets, which can be particularly beneficial for patients with difficulty swallowing[5].

Regulatory Changes

The European Medicines Agency has recommended changes to the use of metoclopramide-containing medicines to reduce the risk of neurological side effects. These changes include restricting maximum recommended doses and removing higher strength formulations from the market to minimize the risk of overdose, especially in children[3].

Competitive Landscape

The market for gastrointestinal medications is competitive, with various drugs available for similar indications. However, Reglan ODT's unique formulation and established efficacy profile maintain its position in the market. The introduction of new formulations, such as Gimoti, which is a nasal spray version of metoclopramide, may also impact the market dynamics by offering alternative delivery methods[4].

Projections and Future Outlook

Market Growth

The demand for effective treatments for GERD and diabetic gastroparesis is expected to grow due to increasing prevalence rates and an aging population. Reglan ODT, with its proven efficacy and safety profile, is likely to continue being a preferred option for healthcare providers.

Regulatory Compliance

Compliance with the new regulatory guidelines set by the European Medicines Agency and other regulatory bodies will be crucial for the continued availability of Reglan ODT. Manufacturers will need to ensure that their formulations adhere to the recommended dose restrictions and safety measures to minimize adverse effects[3].

Innovations and New Formulations

The development of new formulations, such as Gimoti, which has shown promising results in clinical trials, may expand the market share of metoclopramide-based treatments. These innovations could attract more patients and healthcare providers, further solidifying the position of Reglan ODT and its counterparts in the market[4].

Key Takeaways

• Clinical Efficacy: Reglan ODT is effective in treating GERD and diabetic gastroparesis, with clinical trials demonstrating significant improvements in symptoms.
• Safety Profile: While generally well-tolerated, Reglan ODT carries risks such as tardive dyskinesia and other extrapyramidal symptoms, particularly with long-term use.
• Market Position: Reglan ODT remains a preferred treatment option due to its convenience and established efficacy.
• Regulatory Changes: Manufacturers must comply with new regulatory guidelines to ensure the continued availability of the medication.
• Future Outlook: The market is expected to grow, driven by increasing demand for effective gastrointestinal treatments and the introduction of new formulations.

FAQs

What are the primary indications for Reglan ODT?

Reglan ODT is indicated for the treatment of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy and for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis[1].

What are the recommended dosages for Reglan ODT?

The recommended adult dosage is 10 to 15 mg four times daily for 4 to 12 weeks, administered 30 minutes before each meal and at bedtime, with a maximum recommended daily dosage of 60 mg[1].

What are the potential side effects of Reglan ODT?

Potential side effects include drowsiness, restlessness, movement disorders, and the risk of developing tardive dyskinesia with longer-term use[1][2].

How does Reglan ODT compare to other formulations of metoclopramide?

Reglan ODT offers better tolerability and convenience compared to traditional tablets, and new formulations like Gimoti provide alternative delivery methods that may enhance patient compliance[5][4].

What regulatory changes have been made regarding metoclopramide-containing medicines?

The European Medicines Agency has recommended restricting maximum recommended doses and removing higher strength formulations from the market to minimize the risk of overdose and neurological side effects[3].

Sources

1. RxList: Reglan ODT (Metoclopramide Orally Disintegrating Tablets) - RxList.
2. Synapse: Metoclopramide Hydrochloride - Drug Targets, Indications, Patents.
3. European Medicines Agency: Metoclopramide-containing medicines - referral.
4. Evoke Pharma: Evoke Pharma, Inc. - Annual Reports.
5. SCIRP: Effects of Metoclopramide Orally Disintegrating Tablet in Optimizing ...