CLINICAL TRIALS PROFILE FOR DYCLONINE HYDROCHLORIDE

All Clinical Trials for dyclonine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03352700 ↗	Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy	Unknown status	Changhai Hospital	Phase 4	2017-12-01	In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.
NCT01566448 ↗	Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash	Completed	Aaron Cumpston, PharmD	Phase 2	2012-02-01	Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).
NCT01566448 ↗	Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash	Completed	Aaron Cumpston, PharmD, BCOP	Phase 2	2012-02-01	Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).

Clinical Trial Conditions for dyclonine hydrochloride

Condition Name

Condition Name for dyclonine hydrochloride
Intervention	Trials
Adenoma Detection Rate	1
Bowel Preparation Scale	1
Mucositis	1
the Amount of Air Bubble	1

Condition MeSH

Condition MeSH for dyclonine hydrochloride
Intervention	Trials
Adenoma	1
Mucositis	1

Clinical Trial Locations for dyclonine hydrochloride

Trials by Country

+

−

Trials by Country for dyclonine hydrochloride
Location	Trials
China	1
United States	1

Trials by US State

+

−

Trials by US State for dyclonine hydrochloride
Location	Trials
West Virginia	1

Clinical Trial Progress for dyclonine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dyclonine hydrochloride
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for dyclonine hydrochloride
Clinical Trial Phase	Trials
Completed	1
Unknown status	1

Clinical Trial Sponsors for dyclonine hydrochloride

Sponsor Name

Sponsor Name for dyclonine hydrochloride
Sponsor	Trials
Aaron Cumpston, PharmD	1
Aaron Cumpston, PharmD, BCOP	1
Changhai Hospital	1

Sponsor Type

Sponsor Type for dyclonine hydrochloride
Sponsor	Trials
Other	3

Dyclonine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Dyclonine Hydrochloride

Dyclonine hydrochloride is a local anesthetic commonly used in various medical applications, including topical anesthetics, lozenges, sprays, and creams for pain relief. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are currently underway or have recently been completed to evaluate the efficacy and safety of dyclonine hydrochloride in different settings.

• Impact of Different Administration Methods of Dyclonine on Postoperative Throat Pain: This Phase 4, randomized controlled trial investigates the effects of different administration methods of dyclonine hydrochloride on postoperative throat pain after laparoscopic gynecological surgery. The trial, which started in June 2024, aims to compare the efficacy of various administration methods[4].

• Effects of Dyclonine Gel and Compound Lidocaine Cream as Catheter Lubricants: This early Phase 1 trial, recruiting since July 2022, examines the effects of dyclonine gel and compound lidocaine cream as catheter lubricants on postoperative airway complications in patients with endotracheal intubation under general anesthesia[4].

• Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy: In this Phase 4 trial, which began in December 2017, patients were randomized to receive either only polyethylene glycol (PEG) or PEG plus dyclonine hydrochloride mucilage before colonoscopy. The study found that the addition of dyclonine hydrochloride improved the visibility during the procedure and did not increase adverse reactions[4].

Potential Therapeutic Applications

Recent studies have also explored the potential of dyclonine hydrochloride in treating conditions beyond its traditional use as a local anesthetic.

• Parkinson's Disease: Research using a rotenone-induced Drosophila model of Parkinson's disease has shown that dyclonine hydrochloride can improve motor ability and reduce the loss of dopaminergic neurons. This suggests a potential role for dyclonine in the treatment of Parkinson's disease, although further human trials are needed[4].

Market Analysis

Current Market Size and Growth

The global dyclonine hydrochloride market is experiencing steady growth driven by several key factors.

• Market Size: As of 2022, the global dyclonine hydrochloride market size was approximately USD 66.8 million. It is projected to grow to USD 95.6 million by 2032, with a compound annual growth rate (CAGR) of 3.7% from 2023 to 2032[2].

• Key Drivers: The market expansion is fueled by increasing demand in pharmaceuticals, particularly in topical anesthetics, and the growing awareness of dyclonine hydrochloride's benefits in pain management and medical procedures. Technological advancements in drug delivery systems, such as sustained-release and targeted delivery systems, are also enhancing the market[2].

Market Segmentation

The market can be segmented based on type, application, and region.

• Type: The market is segmented into dyclonine hydrochloride with purity levels up to 99% and above 99%. The segment with purity up to 99% has a significant impact on the market due to its widespread use in various applications[5].

• Application: The primary applications include industrial and laboratory settings, with the pharmaceutical sector being the largest consumer. Dyclonine hydrochloride is used in topical anesthetics, lozenges, sprays, and creams for pain relief[2].

• Regional Insights: The market is expected to grow significantly in both developed and emerging regions. Increasing consumer awareness and regulatory approvals for new indications are driving growth in these areas[2].

Market Projections

Future Outlook

The global dyclonine hydrochloride market is poised for steady growth over the next decade.

• Growth Drivers: The increasing demand for pain management solutions, particularly in the pharmaceutical and healthcare sectors, will continue to drive market expansion. Advances in drug delivery systems, expanding indications for dyclonine hydrochloride, and rising demand in emerging markets are key growth opportunities[2].

• Regional Expansion: Companies that invest in product innovation, regulatory compliance, and strategic market expansion into emerging regions are likely to gain a competitive edge. Marketing and awareness campaigns aimed at healthcare professionals and consumers will also play a crucial role in driving demand[2].

Technological Advancements

Drug Delivery Systems

Innovations in drug delivery systems are enhancing the efficacy of dyclonine hydrochloride. Advanced formulations such as sustained-release and targeted delivery systems are improving patient outcomes and increasing the demand for the drug.

• Example: Research has developed films loaded with dyclonine hydrochloride and dexamethasone for the treatment of oral ulcers. These films have a high Young's modulus and large strain, adhering strongly to tissue and providing controlled drug release rates. This technology demonstrates the potential for dyclonine hydrochloride in new therapeutic applications[4].

Consumer Preference and Awareness

Growing Popularity

Consumers are increasingly seeking products that offer quick and effective pain relief with minimal side effects. Dyclonine hydrochloride's efficacy as a topical anesthetic, along with its favorable safety profile, is contributing to its growing popularity in over-the-counter products.

• Regulatory Approvals: Regulatory approvals for new indications of dyclonine hydrochloride are creating additional market opportunities. As more pharmaceutical companies receive approvals for new uses of the compound, the market is expected to expand further, particularly in emerging regions[2].

Key Takeaways

• Clinical Trials: Ongoing trials are exploring the efficacy of dyclonine hydrochloride in various medical settings, including postoperative pain management and potential therapeutic applications in Parkinson's disease.
• Market Growth: The global dyclonine hydrochloride market is expected to grow from USD 66.8 million in 2022 to USD 95.6 million by 2032, with a CAGR of 3.7%.
• Market Drivers: Increasing demand for pain management solutions, technological advancements in drug delivery systems, and expanding indications are key drivers of market growth.
• Regional Expansion: Emerging regions offer significant growth opportunities due to increasing consumer awareness and regulatory approvals.

FAQs

What is the current market size of the dyclonine hydrochloride market?

The current market size of the dyclonine hydrochloride market was approximately USD 66.8 million in 2022[2].

What is the projected growth rate of the dyclonine hydrochloride market?

The market is projected to grow at a CAGR of 3.7% from 2023 to 2032[2].

What are the primary applications of dyclonine hydrochloride?

The primary applications include topical anesthetics, lozenges, sprays, and creams for pain relief in various medical conditions[2].

Are there any ongoing clinical trials for dyclonine hydrochloride?

Yes, there are several ongoing clinical trials evaluating the efficacy and safety of dyclonine hydrochloride in different settings, including postoperative pain management and potential therapeutic applications in Parkinson's disease[4].

What technological advancements are driving the growth of the dyclonine hydrochloride market?

Innovations in drug delivery systems, such as sustained-release and targeted delivery systems, are enhancing the efficacy of dyclonine hydrochloride and driving market growth[2].

Sources

1. OpenPR: Dyclonine Hydrochloride Market Set for Steady Growth: Market Insights and Forecast Till 2032[2].
2. GlobeNewswire: Clinical Trial Supplies Industry Forecast Report 2025-2033[3].
3. Synapse: Dyclonine Hydrochloride - Drug Targets, Indications, Patents[4].
4. Cognitive Market Research: Global Dyclonine Hydrochloride Market Report 2024 Edition[5].