CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

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	NCT04026945 ↗	Sustained Release Lidocaine for Treatment of Scrotal Pain	Completed	University of British Columbia	Phase 1/Phase 2	2019-10-31	In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing chronic scrotal pain (CSCP). The new formulation ST-CP is a lidocaine sustained-release formulation and is expected to provide pain relief over 4 weeks. Currently, the drug lidocaine is not available as an injectable slow-release formulation and chronic scrotal pain patients are often left untreated.
OTC	NCT02749123 ↗	Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis	Unknown status	J.A.R. Laboratories	N/A	2016-04-01	A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	National Cancer Institute (NCI)	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
OTC	NCT02229539 ↗	Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy	Completed	Alliance for Clinical Trials in Oncology	Phase 3	2014-11-01	The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.
New Formulation	NCT01348243 ↗	Efficacy Of Clodronate 200 Mg/4 Ml I.M. Solution With 1% Lidocaine Every Other Week Vs Clodronate 100 Mg/3,3ml I.M. Solution With 1% Lidocaine Once-Week In A 1-Year Treatment Period Of Women With Postmenopausal Osteoporosis	Completed	Chiesi Farmaceutici S.p.A.	Phase 3	2011-10-01	Clodronic acid 100 mg/3,3 ml is used to prevent and treat postmenopausal osteoporosis. The intramuscular formulation, which is given at a dose of 100 mg every 7 o 14 days, is at least as effective as daily oral therapy and appears more effective than intermittent intravenous treatment. Intramuscular clodronic acid in particular has also been associated with improvements in back pain. The drug is well tolerated, with no deleterious effects on bone mineralization, and use of parenteral therapy eliminates the risk of gastrointestinal adverse effects that may be seen in patients receiving oral bisphosphonates therapy. In order to simplify the therapeutic dosing regimen, reducing the number of administrations per month, and therefore increase adherence to bisphosphonates therapy of the patient, a new formulation of disodium clodronic acid containing 200 mg/4 mL for i.m. administration has been developed. Lidocaine in this new formulation, as local anaesthetic, is maintained at the same concentration as in the 100 mg clodronic acid formulation. The pharmacokinetics and tolerability of the intramuscular formulation of clodronic acid 200 mg in comparison to the marketed formulation clodronic acid 100 mg was evaluated in healthy post-menopausal volunteers. Two formulations were similar in terms of amount and rate of clodronic acid urinary excretion and in terms of safety profile.

All Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001784 ↗	Mexiletine for the Treatment of Focal Dystonia	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1998-07-01	Dystonia refers to a condition characterized by involuntary muscle contractions that may cause pain, abnormal posture, or abnormal movements. The cause of dystonia is unknown, but some researchers believe it is a result of overactivity in the areas of the brain responsible for movement (basal ganglia). Lidocaine is a drug used for the treatment of irregular heartbeats. It is given by injection. Recent studies have shown that lidocaine is also effective for the treatment dystonia. Mexiletine is a drug similar to lidocaine used for irregular heartbeats that can be taken by mouth. Researchers would like to test the effectiveness of Mexiletine for the treatment of dystonia. Patients participating in the study will be divided into two groups; Group 1 will take Mexiletine for six weeks then stop. They will remain drug free for one week then begin taking a placebo "inactive sugar pill" for an additional six weeks. Group 2 will take a placebo "inactive sugar pill" for six weeks then stop. They will remain drug free for one week then begin taking a Mexiletine for an additional six weeks. Throughout the study researchers will test the effectiveness of the treatment by evaluating patients using clinical rating scales and neurophysiological studies. In addition, researchers will test patient's reflexes in an attempt to find out where mexiletine works in the nervous system.
NCT00001724 ↗	Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1997-11-01	This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
NCT00002901 ↗	Docetaxel in Treating Patients With Solid Tumors and Abnormal Liver Function	Completed	National Cancer Institute (NCI)	Phase 1	1996-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of docetaxel in treating patients with advanced solid tumors that have not responded to standard therapy or for which there is no effective therapy.
NCT00001524 ↗	Thalidomide to Treat Oral Lesions in HIV-Infected Patients	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1996-06-01	This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
NCT00001303 ↗	Effects of Endotoxin in Normal Human Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	1992-04-06	Bacterial infections can progress to a life-threatening illness called septic shock, characterized by low blood pressure and vital organ damage. The syndrome is thought to be caused by parts of the bacteria and by the body s own immune response to the infection. A major bacterial product that interacts with the immune defenses is called endotoxin. This study will examine the body s response to endotoxin in the lungs or bloodstream. When endotoxin is given in small amounts to humans, even though it is not an infection, it triggers a set of responses that are typical of what one would see with a true bacterial infection. This allows us to study the earliest changes in molecules and cells that are involved in some bacterial infections. This type of model is safe and has been used in humans for many years to understand the body s responses during infections. Normal volunteers 18 to 45 years of age may be eligible for this study. Candidates will have a history and physical examination, blood and urine tests, electrocardiogram (EKG) and chest X-ray. In addition, volunteers 40 to 45 years old will have an exercise stress test to screen for asymptomatic coronary artery disease. Participants will undergo one or more of the following procedures: Bronchoscopy, Bronchoalveolar Lavage, Bronchial Brushings, and Endobronchial Mucosal Biopsies: These techniques for examining lung function are used routinely in patient care and clinical research. The mouth and nasal and lung airways are numbed with an anesthetic. A bronchoscope (pencil-thin flexible tube) is then passed through the nose into the large airways of the lung. Cells and secretions from the airways are rinsed with salt water (bronchoalveolar lavage) and a flexible brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways. Lastly, pieces of tissue (the size of the ball of a ballpoint pen) lining the airways are removed for examination under the microscope. Intravenous Endotoxin: A small dose of endotoxin is injected into a vein. Blood samples are drawn at regular intervals for 8 hours after the injection and again after 1, 2, 3, 7 and 14 days to analyze the body s immune response to the bacteria in the blood. Instilled Endotoxin in the Lungs: A small amount (2 teaspoons) of salt water is squirted through a bronchoscope into a lobe of one lung, and then salt water containing a small dose of endotoxin is squirted into the other lung. Bronchial lavage, brushing, and biopsy (see above) are then done to study the response of the lung to the endotoxin. In addition, air is withdrawn through the bronchoscope to study air components from the lung that was instilled with salt water or endotoxin. Nitric Oxide Therapy: Endotoxin is instilled in a lung (see above) and then nitric oxide a colorless, odorless, tasteless gas mixed with room air in a concentration of 40 parts per million, is given through a cushioned mask placed over the mouth and nose. (Some participants will be given the nitric oxide mixture and others will breathe only room air through the mask to test the effects of the nitric oxide on the lung inflammation.) The mask will be worn continuously for 6 hours and removed before repeat bronchoscopy with lavage, brushing and biopsy. Some of the above procedures require placement of a catheter (thin plastic tube) in a wrist artery to monitor blood pressure from heartbeat to heartbeat and to collect blood samples. First, the skin is numbed with an anesthetic (lidocaine). A needle is then inserted into the artery, the catheter is slipped over the needle into the vessel, and the needle is removed.

Clinical Trial Conditions for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Condition Name

Condition Name for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Pain	191
Postoperative Pain	75
Pain, Postoperative	69
Anesthesia	62

Condition MeSH

Condition MeSH for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Intervention	Trials
Pain, Postoperative	190
Neuralgia	56
Acute Pain	37
Syndrome	36

Clinical Trial Locations for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Trials by Country

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Trials by Country for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
Egypt	170
Canada	111
China	70
France	56
Brazil	53

Trials by US State

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Trials by US State for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Location	Trials
California	115
New York	66
Pennsylvania	62
Texas	59
North Carolina	55

Clinical Trial Progress for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	571
Phase 3	214
Phase 2/Phase 3	58

Clinical Trial Status

Clinical Trial Status for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	936
Recruiting	281
Unknown status	208

Clinical Trial Sponsors for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Assiut University	45
Cairo University	27
Northwestern University	22

Sponsor Type

Sponsor Type for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	2027
Industry	214
U.S. Fed	49

Lidocaine Hydrochloride 0.2% in Dextrose 5%: Clinical Trials, Market Analysis, and Projections

Introduction

Lidocaine Hydrochloride 0.2% in Dextrose 5% is a sterile, nonpyrogenic solution widely used in medical settings for its anesthetic and antiarrhythmic properties. Here, we will delve into the current clinical trials, market analysis, and future projections for this formulation.

Clinical Uses and Indications

Lidocaine Hydrochloride 0.2% in Dextrose 5% is primarily used for intravenous administration to treat ventricular tachycardia and premature ventricular beats, especially in cases of acute myocardial infarction, digitalis toxicity, or other cardiac diseases. It is also used as a continuous intravenous infusion when fluid restriction is necessary[1][4].

Pharmacokinetics and Administration

The solution contains 0.2% lidocaine hydrochloride and 5% dextrose in water for injection. The administration rates vary, typically ranging from 1-4 mg/min for adults, with careful monitoring of electrocardiographic and blood pressure parameters essential during infusion. Pediatric patients require adjusted dosages, typically around 30 mcg/kg/min[1].

Clinical Trials and Safety Considerations

While specific recent clinical trials for Lidocaine Hydrochloride 0.2% in Dextrose 5% are not extensively detailed in the available sources, it is crucial to note that prolonged infusion can lead to reduced elimination of lidocaine, resulting in toxic accumulation. Therefore, adjusting the infusion rate according to the patient's ability to eliminate the drug is critical[1].

Contraindications and Side Effects

Lidocaine is contraindicated in patients with hypersensitivity to amide-type local anesthetics, severe heart block, or advanced hepatic disease. Common side effects include central nervous system toxicity and cardiovascular effects, emphasizing the need for careful patient monitoring[4].

Market Analysis

Market Size and Growth

The global lidocaine hydrochloride market, which includes various formulations such as the 0.2% in Dextrose 5% solution, was estimated to be around USD 0.773 billion in 2023. It is projected to grow to USD 1.56 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 6.57% during the forecast period[3].

Driving Factors

The market growth is driven by several key factors:

• Increasing Surgical Procedures: The rise in surgical procedures, including dental and cosmetic surgeries, increases the demand for lidocaine hydrochloride.
• Growing Prevalence of Chronic Pain: The increasing prevalence of chronic pain conditions necessitates effective pain management solutions, contributing to market growth.
• Technological Advancements: Developments in drug delivery technologies enhance the effectiveness and flexibility of lidocaine hydrochloride formulations.
• Aging Population: The expanding elderly population, which requires more medical interventions, also propels the market[2][3].

Market Segmentation

The lidocaine hydrochloride market is segmented based on dosage, application, distribution channel, and region. Dental procedures account for a significant market share due to the widespread use of lidocaine hydrochloride for numbing during dental interventions. Retail pharmacies are expected to witness the highest growth in the distribution channels segment due to increasing demand and accessibility[2][3].

Regional Dominance

North America dominates the global lidocaine hydrochloride market, driven by the rising number of aging people, increasing surgical procedures, and technological advancements in various medical fields[2][3].

Regulatory Scrutiny and Challenges

Despite the growth potential, the lidocaine hydrochloride market faces several challenges:

• Regulatory Scrutiny: Stringent safety standards and thorough approvals are required, posing a challenge to market growth.
• Potential Side Effects: The need for continuous research to address safety concerns and potential side effects adds complexity to market dynamics.
• Competition: Intense competition from alternative pain management solutions also impacts market growth[2][3].

Future Projections

Market Expansion

The lidocaine hydrochloride market is expected to continue growing, driven by the increasing demand for pain management solutions and the expanding elderly population. The development of new formulations and advancements in drug delivery technologies will further enhance market growth.

Emerging Applications

Lidocaine hydrochloride is expected to see increased adoption in diverse and emerging applications across various medical specialties, contributing to its market expansion[3].

Distribution Channels

Retail pharmacies will continue to play a crucial role in distributing lidocaine products, driven by growing awareness and accessibility[2].

Key Takeaways

• Lidocaine Hydrochloride 0.2% in Dextrose 5% is a critical formulation used in treating cardiac arrhythmias and providing anesthesia.
• The global lidocaine hydrochloride market is projected to grow significantly, driven by increasing surgical procedures, chronic pain prevalence, and technological advancements.
• Regulatory scrutiny and potential side effects are key challenges that need to be addressed.
• North America dominates the market, with retail pharmacies expected to see significant growth in distribution.

FAQs

What are the primary clinical uses of Lidocaine Hydrochloride 0.2% in Dextrose 5%?

Lidocaine Hydrochloride 0.2% in Dextrose 5% is primarily used for treating ventricular tachycardia and premature ventricular beats, especially in cases of acute myocardial infarction or digitalis toxicity.

What are the key factors driving the growth of the lidocaine hydrochloride market?

The market growth is driven by increasing surgical procedures, growing prevalence of chronic pain, technological advancements in drug delivery, and the expanding elderly population.

Which region dominates the global lidocaine hydrochloride market?

North America dominates the global lidocaine hydrochloride market due to the rising number of aging people and increasing surgical procedures.

What are the main challenges facing the lidocaine hydrochloride market?

The main challenges include regulatory scrutiny, potential side effects, and intense competition from alternative pain management solutions.

How is the lidocaine hydrochloride market segmented?

The market is segmented based on dosage, application, distribution channel, and region, with dental procedures and retail pharmacies being significant segments.

Sources

1. DailyMed: Lidocaine Hydrochloride and 5% Dextrose Injection USP.
2. Polaris Market Research: Lidocaine Hydrochloride Market Size, Share, Global Analysis Report.
3. GlobeNewswire: Global Lidocaine Hydrochloride Market Report 2024.
4. Health Canada: 2% Lidocaine Hydrochloride Injection USP 20 mg/mL 0.4% Lidocaine Hydrochloride and 5% Dextrose Injection USP.