CLINICAL TRIALS PROFILE FOR ALCOHOL 5% IN DEXTROSE 5% IN WATER

505(b)(2) Clinical Trials for Alcohol 5% In Dextrose 5% In Water

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00071227 ↗	Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders	Completed	National Eye Institute (NEI)	Phase 1	2003-10-15	This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation. This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known. Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study: - Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older) - Macular edema associated with retinal vein occlusion (18 years of age and older) - Diabetic macular edema ((18 years of age and older) Participants undergo the following tests and procedures: - Medical history and physical examination - Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination. - Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light. - Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same. - Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye. - Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment. - Blood tests to measure liver and kidney function. Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment. Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.
OTC	NCT00754247 ↗	A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars	Completed	University of Miami	Phase 4	2006-03-01	Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.

All Clinical Trials for Alcohol 5% In Dextrose 5% In Water

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000152 ↗	Randomized Trial of Beta-Carotene and Macular Degeneration	Unknown status	National Eye Institute (NEI)	Phase 3	1982-04-01	To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000159 ↗	Sorbinil Retinopathy Trial (SRT)	Completed	National Eye Institute (NEI)	Phase 3	1983-08-01	To evaluate the safety and efficacy of the investigational drug sorbinil, an aldose reductase inhibitor, in preventing the development of diabetic retinopathy and neuropathy in persons with insulin-dependent diabetes.
NCT00000161 ↗	Randomized Trials of Vitamin Supplements and Eye Disease	Unknown status	National Eye Institute (NEI)	Phase 3	1993-08-01	To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes.

Clinical Trial Conditions for Alcohol 5% In Dextrose 5% In Water

Condition Name

Condition Name for Alcohol 5% In Dextrose 5% In Water
Intervention	Trials
Alcoholism	184
Alcohol Use Disorder	169
Alcohol Dependence	159

Condition MeSH

Condition MeSH for Alcohol 5% In Dextrose 5% In Water
Intervention	Trials
Alcoholism	553
Alcohol Drinking	234
Disease	188

Clinical Trial Locations for Alcohol 5% In Dextrose 5% In Water

Trials by Country

Trials by Country for Alcohol 5% In Dextrose 5% In Water
Location	Trials
Canada	123
United Kingdom	54
Germany	42
China	36
Brazil	36

Trials by US State

Trials by US State for Alcohol 5% In Dextrose 5% In Water
Location	Trials
California	174
New York	127
Texas	126
Connecticut	119
Maryland	111

Clinical Trial Progress for Alcohol 5% In Dextrose 5% In Water

Clinical Trial Phase

Clinical Trial Phase for Alcohol 5% In Dextrose 5% In Water
Clinical Trial Phase	Trials
Phase 4	434
Phase 3	222
Phase 2/Phase 3	73

Clinical Trial Status

Clinical Trial Status for Alcohol 5% In Dextrose 5% In Water
Clinical Trial Phase	Trials
Completed	1135
Recruiting	260
Not yet recruiting	200

Clinical Trial Sponsors for Alcohol 5% In Dextrose 5% In Water

Sponsor Name

Sponsor Name for Alcohol 5% In Dextrose 5% In Water
Sponsor	Trials
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	274
Yale University	97
National Institute on Drug Abuse (NIDA)	91

Sponsor Type

Sponsor Type for Alcohol 5% In Dextrose 5% In Water
Sponsor	Trials
Other	2425
NIH	527
Industry	463

Alcohol 5% in Dextrose 5% in Water: Clinical Trials, Market Analysis, and Projections

Introduction

Alcohol 5% in Dextrose 5% in Water is a sterile, nonpyrogenic, hypertonic solution used for parenteral replenishment of fluid and carbohydrate calories. This solution combines ethyl alcohol and dextrose in water, making it a valuable tool in clinical settings for various indications.

Clinical Indications and Usage

This solution is indicated for patients whose oral intake is restricted or inadequate to maintain nutritional requirements. It provides a source of water and carbohydrate calories, particularly useful in increasing caloric intake in patients with limited oral nutrition[1].

Clinical Pharmacology

The solution is metabolized by the body, with ethyl alcohol being metabolized at a rate of approximately 10 to 20 mL per hour, depending on body weight and tolerance. Dextrose can be infused at a maximum rate of 0.5 g/kg of body weight per hour without producing glycosuria. The sedative effects of alcohol can occur if the infusion rate exceeds the metabolic rate[1].

Contraindications and Precautions

Alcohol in this solution is contraindicated in patients with epilepsy, urinary tract infections, diabetic coma, and those with a history of alcohol addiction. It should be administered slowly, and patients should be observed for restlessness or narcosis. Additionally, it can interact with various medications, such as antihypertensive drugs, and may potentiate postural hypotension[1].

Clinical Trials and Efficacy

While there are no specific clinical trials focused solely on Alcohol 5% in Dextrose 5% in Water, the component of dextrose in similar solutions has been studied extensively. For instance, 5% dextrose water injections have been used effectively in treating peripheral entrapment neuropathies, such as carpal tunnel syndrome and ulnar neuropathy at the elbow. These studies highlight the therapeutic potential of dextrose solutions in clinical settings[3][5].

Perineural Injection Therapy (PIT) with Dextrose

PIT using 5% dextrose water has shown promising results in treating peripheral entrapment neuropathies. The mechanism involves both pharmacological and mechanical effects, including hydrodissection, which helps in relieving nerve compression. This method is increasingly recommended as an alternative local treatment for conditions like carpal tunnel syndrome[3][5].

Market Analysis

Dextrose Market Overview

The global dextrose market is experiencing significant growth, driven by various factors including the expansion of the food and beverage industry, the pharmaceutical sector, and the increasing demand for convenience foods and sports drinks. The market size is projected to grow from $5.8 billion in 2023 to $6.29 billion in 2024 and further to $8.49 billion by 2028, at a compound annual growth rate (CAGR) of 7.8%[2].

Segmentation of the Dextrose Market

The dextrose market is segmented by type (anhydrous and monohydrate), form (crystalline, powdered, and liquid), and application (food and beverage, confectionery, bakery, dairy, pharmaceuticals, and others). The pharmaceutical sector is a significant driver, with dextrose being used in various medical applications, including intravenous administration to provide energy and manage hypoglycemia[2].

Market Projections

Growth Drivers

The growth of the dextrose market is driven by several factors:

• Expanding Pharmaceutical Sector: The increasing expenditure on pharmaceuticals, projected to range between $380 and $400 billion by 2025 in the US, is a significant driver[2].
• Rising Demand in Confectionery and Functional Foods: Growing demand in the confectionery industry and the increasing adoption of functional foods are expected to propel the market forward[2].
• Advancements in Biotechnology: Innovations in biotechnology and clean-label formulations are also contributing to the market's growth[2].

Restraints and Challenges

Despite the growth, there are several restraints and challenges:

• Regulatory Compliance: Strict regulatory requirements can hinder market growth.
• Competition from Alternatives: The availability of alternative sweeteners and energy sources can pose a challenge to the dextrose market[2].

Dosage and Administration

Alcohol 5% in Dextrose 5% in Water should be administered by slow intravenous infusion. The recommended dosage ranges from 1 to 2 liters per day, depending on the patient's needs. It is crucial to monitor the patient for restlessness, narcosis, and other adverse effects, and to ensure that the solution is clear and the seal is intact before administration[1].

Key Takeaways

• Clinical Indications: The solution is used for parenteral replenishment of fluid and carbohydrate calories.
• Metabolism: Ethyl alcohol is metabolized at a rate of 10 to 20 mL per hour, and dextrose at 0.5 g/kg of body weight per hour.
• Contraindications: It is contraindicated in patients with epilepsy, urinary tract infections, diabetic coma, and alcohol addiction.
• Market Growth: The dextrose market is growing significantly, driven by the pharmaceutical and food industries.
• Future Projections: The market is expected to reach $8.49 billion by 2028, with a CAGR of 7.8%.

FAQs

What is the primary indication for Alcohol 5% in Dextrose 5% in Water?

The primary indication is for parenteral replenishment of fluid and carbohydrate calories, especially in patients with restricted or inadequate oral intake.

How is Alcohol 5% in Dextrose 5% in Water metabolized?

Ethyl alcohol is metabolized at a rate of approximately 10 to 20 mL per hour, and dextrose at 0.5 g/kg of body weight per hour.

What are the contraindications for this solution?

It is contraindicated in patients with epilepsy, urinary tract infections, diabetic coma, and those with a history of alcohol addiction.

What is the projected growth of the dextrose market?

The dextrose market is expected to grow from $5.8 billion in 2023 to $8.49 billion by 2028, at a CAGR of 7.8%.

What are the common applications of dextrose in the pharmaceutical sector?

Dextrose is used in various medical applications, including intravenous administration to provide energy, manage hypoglycemia, and support hydration.

Sources

1. Drugs.com: Alcohol in Dextrose: Package Insert / Prescribing Info.
2. The Business Research Company: Global Dextrose Market Report 2024.
3. PubMed: Efficacy of 5% Dextrose Water Injection for Peripheral Entrapment Neuropathy.
4. Baxter: 5% Dextrose Injection, USP.
5. MDPI: Efficacy of 5% Dextrose Water Injection for Peripheral Entrapment Neuropathy: A Narrative Review.