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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER


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505(b)(2) Clinical Trials for Lidocaine Hydrochloride 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 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.
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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lidocaine Hydrochloride In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
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.
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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lidocaine Hydrochloride In Plastic Container

Condition Name

Condition Name for Lidocaine Hydrochloride In Plastic Container
Intervention Trials
Pain 191
Postoperative Pain 75
Pain, Postoperative 69
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Condition MeSH

Condition MeSH for Lidocaine Hydrochloride In Plastic Container
Intervention Trials
Pain, Postoperative 190
Neuralgia 56
Acute Pain 37
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Clinical Trial Locations for Lidocaine Hydrochloride In Plastic Container

Trials by Country

Trials by Country for Lidocaine Hydrochloride In Plastic Container
Location Trials
Egypt 170
Canada 111
China 70
France 56
Brazil 53
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Trials by US State

Trials by US State for Lidocaine Hydrochloride In Plastic Container
Location Trials
California 115
New York 66
Pennsylvania 62
Texas 59
North Carolina 55
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Clinical Trial Progress for Lidocaine Hydrochloride In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Lidocaine Hydrochloride In Plastic Container
Clinical Trial Phase Trials
Phase 4 571
Phase 3 214
Phase 2/Phase 3 58
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Clinical Trial Status

Clinical Trial Status for Lidocaine Hydrochloride In Plastic Container
Clinical Trial Phase Trials
Completed 936
Recruiting 281
Unknown status 208
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Clinical Trial Sponsors for Lidocaine Hydrochloride In Plastic Container

Sponsor Name

Sponsor Name for Lidocaine Hydrochloride In Plastic Container
Sponsor Trials
Assiut University 45
Cairo University 27
Northwestern University 22
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Sponsor Type

Sponsor Type for Lidocaine Hydrochloride In Plastic Container
Sponsor Trials
Other 2027
Industry 214
U.S. Fed 49
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Lidocaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Last updated: January 12, 2025

Introduction to Lidocaine Hydrochloride

Lidocaine hydrochloride is a widely used local anesthetic that blocks sodium channels in nerve membranes, preventing the initiation and transmission of pain signals. It is versatile, available in various dosage forms such as topical creams, patches, and injectable solutions, making it a staple in medical procedures for pain management.

Clinical Trials Update

Interstitial Cystitis Trial

One notable clinical trial involving lidocaine hydrochloride is the study conducted by UCSD on interstitial cystitis (IC) / bladder pain syndrome (BPS). This Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center study aims to evaluate the efficacy and safety of a combination product (VNX001) that includes lidocaine hydrochloride and heparin sodium compared to its individual components and a placebo. The study focuses on reducing bladder pain in patients with moderate to severe acute bladder pain. Participants will receive a single dose of VNX001, placebo, alkalinized lidocaine, or alkalinized heparin, with a randomization ratio of 3:1:3:1, respectively[1].

Ocular Surface Anesthesia

Another clinical trial involves the use of lidocaine hydrochloride gel for ocular surface anesthesia. This study, conducted in China, evaluated the pharmacokinetics and effectiveness of a new generic formulation of 3.5% lidocaine hydrochloride ophthalmic gel. The results showed that the lidocaine hydrochloride gel group achieved anesthesia within 5 minutes significantly more often than other groups, highlighting its efficacy in ocular surface anesthesia[4].

Market Analysis

Market Size and Growth

The lidocaine hydrochloride market is poised for significant growth. As of 2023, the market size was valued at USD 752.5 million and is estimated to grow at a CAGR of 5.5% from 2024 to 2032. This growth is driven by the increasing prevalence of chronic pain management and neurological disorders such as epilepsy and heart arrhythmias[5].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the lidocaine hydrochloride market. The potential anesthetic and anti-inflammatory properties of lidocaine in treating COVID-19 patients, particularly in reducing cytokines and protecting patients' lungs, contributed to the market's growth. Additionally, the relaxation of strict regulations on surgical procedures in the post-pandemic period has further boosted demand for lidocaine hydrochloride[2][3].

Application and Dosage Forms

Lidocaine hydrochloride is used in various medical applications, including dental procedures, minor surgeries, and the treatment of cardiac arrhythmic disorders. The market is segmented into different dosage forms such as creams, patches, injectables, and other forms. The injectable segment is expected to lead the market, accounting for the largest revenue, while the dental procedures segment holds the largest market share in terms of application[5].

Geographic Distribution

The U.S. dominates the North American lidocaine hydrochloride market, accounting for USD 274.4 million in 2023. Germany shows high growth potential in the European market, while the Asia Pacific region is poised for rapid growth with a CAGR of 5.9% during the forecast period[5].

Market Trends

Increasing Surgical Procedures

The rise in surgical procedures worldwide, including dental, cosmetic, and orthopedic surgeries, is anticipated to propel market expansion. Enhanced healthcare accessibility and a growing population contribute to the increasing demand for lidocaine hydrochloride as an efficient pain management tool[5].

Advancements in Drug Delivery Systems

Advancements in drug delivery systems, such as topical patches and gels, have expanded the application scope of lidocaine hydrochloride. These innovations enhance patient compliance and efficacy, further driving market growth[5].

Preference Over Opioids

The preference for anesthetics like lidocaine hydrochloride over opioids due to their safer profile and fewer side effects is another factor contributing to market expansion. This shift is driven by growing concerns about opioid addiction and the need for effective, non-addictive pain management solutions[5].

Projections and Future Outlook

Market Size Projections

By 2032, the lidocaine hydrochloride market is expected to grow significantly, driven by the increasing prevalence of chronic pain and neurological disorders. The market is projected to reach a substantial value, with the injectable segment and dental procedures segment continuing to dominate[5].

Emerging Markets

Emerging markets, particularly in the Asia Pacific region, are expected to show rapid growth due to increasing healthcare spending and a growing demand for advanced medical treatments. This region's high growth potential is attributed to its large population and improving healthcare infrastructure[5].

Innovations and New Products

The introduction of new products and formulations by key market players is expected to enhance market growth. Innovations in drug delivery systems and the development of new dosage forms will continue to demonstrate safety and efficacy, further expanding the market[5].

Key Takeaways

  • Clinical Trials: Ongoing trials like the UCSD study on interstitial cystitis and the ocular surface anesthesia trial highlight the continuous evaluation and expansion of lidocaine hydrochloride's therapeutic applications.
  • Market Growth: The lidocaine hydrochloride market is expected to grow at a CAGR of 5.5% from 2024 to 2032, driven by increasing demand in chronic pain management and neurological disorders.
  • COVID-19 Impact: The pandemic has positively impacted the market due to lidocaine's potential benefits in treating COVID-19 patients and the post-pandemic relaxation of surgical regulations.
  • Application and Dosage Forms: The market is dominated by injectable forms and dental procedures, with advancements in drug delivery systems expanding its application scope.
  • Geographic Distribution: The U.S., Germany, and the Asia Pacific region are key markets with significant growth potential.

FAQs

What is the current market size of lidocaine hydrochloride?

The lidocaine hydrochloride market size was valued at USD 752.5 million in 2023[5].

How is the COVID-19 pandemic impacting the lidocaine hydrochloride market?

The COVID-19 pandemic has positively impacted the market due to lidocaine's potential benefits in treating COVID-19 patients and the post-pandemic relaxation of surgical regulations[2][3].

What are the primary applications of lidocaine hydrochloride?

Lidocaine hydrochloride is primarily used for pain relief during dental procedures, minor surgeries, and the treatment of certain cardiac arrhythmic disorders[5].

What are the key drivers of the lidocaine hydrochloride market growth?

Key drivers include the increasing prevalence of chronic pain and neurological disorders, advancements in drug delivery systems, and the preference for anesthetics over opioids[5].

Which region is expected to show the most rapid growth in the lidocaine hydrochloride market?

The Asia Pacific region is poised for rapid growth with a CAGR of 5.9% during the forecast period[5].

Sources

  1. UCSD Interstitial Cystitis Trial: "Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS" - ClinicalTrials.gov
  2. Lidocaine Hydrochloride Market Size: "Lidocaine Hydrochloride Market Size - Mordor Intelligence"
  3. Lidocaine Hydrochloride Market - Growth, Trends, COVID-19 Impact: "Lidocaine Hydrochloride Market - Growth, Trends, COVID-19 Impact" - ResearchAndMarkets
  4. Lidocaine Hydrochloride Gel for Ocular Surface Anesthesia: "Lidocaine Hydrochloride Gel for Ocular Surface Anesthesia - PubMed"
  5. Lidocaine Hydrochloride Market Size & Share Report, 2032: "Lidocaine Hydrochloride Market Size & Share Report, 2032" - Global Market Insights

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