CLINICAL TRIALS PROFILE FOR CHLOROPROCAINE HYDROCHLORIDE

All Clinical Trials for CHLOROPROCAINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01909089 ↗	Determination of the Minimum Local Analgesic Dose of Spinal Chloroprocaine in Labour	Unknown status	University Hospital, Ghent	Phase 4	2013-06-01	Combined spinal-epidural (CSE) analgesia has become a widely accepted approach to provide analgesia for labour pain. Despite the increasingly widespread use of this technique, an optimal intrathecal drug regimen has not been established yet. Several investigations using local anesthetics such as Bupivacaine, Levobupivacaine and Ropivacaine in CSE during labour have been published. But despite the reintroduction of Chloroprocaine recently there haven't been any investigations about spinal chloroprocaine. Chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile. It is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism by plasma cholinesterases and short half-life both in mother and fetus. Because of this beneficial profile, Chloroprocaine is widely used intrathecally for surgical anesthesia. Several investigations demonstrate that for surgical anesthesia doses Chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical duration of 40 - 90 minutes. Despite these "standards" for surgical anesthesia, little is known about spinal Chloroprocaine dose regimens. Therefore the primary goal of this study is to determine the minimum adequate dose of Chloroprocaine that is to be given spinally to a woman in labour using a CSE procedure. We will use the up-down sequential allocation to identify the median effective dose (ED50) or concentration (EC50). The Effective dose in 95% of the population (ED95) can be estimated also from an up-down sequential allocation and will become an important valuable approximation of the clinical dose.
NCT01719237 ↗	Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture	Completed	VA Palo Alto Health Care System	Phase 4	2009-08-01	A double blinded randomized controlled trial comparing the onset and duration of the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic (Ropivacaine-Chloroprocaine Mixture).
NCT01719237 ↗	Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture	Completed	University of New Mexico	Phase 4	2009-08-01	A double blinded randomized controlled trial comparing the onset and duration of the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic (Ropivacaine-Chloroprocaine Mixture).
NCT00845962 ↗	A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia	Completed	Centre hospitalier de l'Université de Montréal (CHUM)	N/A	2009-02-01	The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
NCT00845962 ↗	A Comparison of Bupivacaine and 2-chloroprocaine for Spinal Anesthesia	Completed	Université de Montréal	N/A	2009-02-01	The purpose of this study is to compare the efficacity and the readiness for discharge between two local anesthetics, bupivacaine and 2-chloroprocaine, used for spinal anesthesia.
NCT00487084 ↗	Effect of Timing on Efficacy of Morphine Analgesia After 2-chloroprocaine Anesthesia	Completed	Northwestern University	N/A	2004-08-01	Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1). Several studies have hypothesized a specific opioid receptor mediated antagonism of chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due to a disparity between the time the chloroprocaine anesthesia resolves and the onset of epidural morphine analgesia, resulting in a time window of pain (2). The duration of action of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is 60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3). Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and morphine. There was no difference in postoperative analgesia between the two groups (3 and personal communication, Dr. Philip Hess). A literature search cross referencing epidural chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given before the procedure (in an attempt to time the onset of analgesia with the resolution of chloroprocaine anesthesia) to the standard administration time after the procedure.

Clinical Trial Conditions for CHLOROPROCAINE HYDROCHLORIDE

Condition Name

Condition Name for CHLOROPROCAINE HYDROCHLORIDE
Intervention	Trials
Spinal Anesthesia	3
Anesthesia, Spinal	3
Pain	3
Anesthesia	2

Condition MeSH

Condition MeSH for CHLOROPROCAINE HYDROCHLORIDE
Intervention	Trials
Hernia, Inguinal	3
Uterine Cervical Incompetence	2
Hernia	2
Leg Injuries	1

Clinical Trial Locations for CHLOROPROCAINE HYDROCHLORIDE

Trials by Country

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Trials by Country for CHLOROPROCAINE HYDROCHLORIDE
Location	Trials
United States	15
Belgium	6
Italy	6
Switzerland	3
Spain	3

Trials by US State

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Trials by US State for CHLOROPROCAINE HYDROCHLORIDE
Location	Trials
New York	3
Oregon	2
Arkansas	2
Massachusetts	1
Tennessee	1

Clinical Trial Progress for CHLOROPROCAINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CHLOROPROCAINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CHLOROPROCAINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	23
Recruiting	4
Active, not recruiting	2

Clinical Trial Sponsors for CHLOROPROCAINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for CHLOROPROCAINE HYDROCHLORIDE
Sponsor	Trials
Sintetica SA	10
Cross Research S.A.	3
Cross S.A.	2

Sponsor Type

Sponsor Type for CHLOROPROCAINE HYDROCHLORIDE
Sponsor	Trials
Other	32
Industry	17
U.S. Fed	1

Chloroprocaine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Chloroprocaine Hydrochloride

Chloroprocaine hydrochloride is an ester local anesthetic known for its rapid onset and short duration of action, making it a preferred choice for various medical procedures, particularly in surgical anesthesia and pain management.

Pharmacology of Chloroprocaine Hydrochloride

Chloroprocaine hydrochloride belongs to the class of ester local anesthetics, providing local anesthesia by blocking the conduction of nerve impulses. Its pharmacological profile is characterized by a quick onset of action and a short duration, which is advantageous in outpatient surgeries and procedures requiring rapid patient turnover[1].

Current Clinical Trials

Several clinical trials are ongoing or have been completed to evaluate the efficacy and safety of chloroprocaine hydrochloride in different medical settings.

• Johns Hopkins University: A Phase 3 clinical trial is being conducted to assess the efficacy and safety of chloroprocaine hydrochloride in a specific clinical context[1].
• Sintetica SA: Multiple trials are underway, including a Phase 2/Phase 3 and a Phase 1/Phase 2 study, to further investigate the drug's potential in various medical applications[1].
• Harrow's IHEEZO™: Clinical trials for IHEEZO™, a chloroprocaine hydrochloride ophthalmic gel, have demonstrated its safety and efficacy in ocular surface anesthesia, particularly in patients undergoing cataract surgery. These trials included randomized, double-blinded, placebo-controlled studies and a multi-center, active-controlled study[3][4].

Market Analysis

The market for chloroprocaine hydrochloride injection is experiencing significant growth driven by several key factors.

Increasing Demand for Surgical Procedures

The global increase in surgical procedures necessitates the use of effective and short-acting local anesthetics. Chloroprocaine hydrochloride's rapid onset and short duration make it an ideal choice for many healthcare providers, especially in outpatient surgeries[2].

Advancements in Medical Technology

Advancements in medical technology and anesthesia techniques are enhancing the efficacy and safety of chloroprocaine hydrochloride injections. This has led to increased adoption in various medical settings[2].

Focus on Pain Management

The growing focus on pain management and the need for efficient anesthetic solutions are further propelling the demand for chloroprocaine hydrochloride. Its use in labor and delivery, as well as in other surgical procedures, is becoming more prevalent[5].

Regulatory Approvals and Reimbursement

Recent regulatory approvals, such as the FDA approval of IHEEZO™ for ocular surface anesthesia, and favorable reimbursement policies, including the transitional pass-through reimbursement status approved by CMS, are supporting market growth. This ensures that chloroprocaine hydrochloride products are reimbursed separately by Medicare, enhancing their accessibility[3][4].

Market Projections

The chloroprocaine hydrochloride injection market is projected to witness substantial growth in the coming years.

• Global Market Size: The market is expected to grow from USD 18.58 billion in 2024 to USD 34.89 billion by 2031, with a compound annual growth rate (CAGR) of 9.42%[2].
• Regional Growth: North America, Europe, and the Asia-Pacific region are significant contributors to the market growth. The Asia-Pacific region, in particular, is expected to see rapid growth due to its large population, rising disposable income, and increasing urbanization[2].
• Segmented Growth: The market is driven by the increasing prevalence of surgical procedures, rising awareness around patient safety, advancements in healthcare infrastructure, and the growing demand for local anesthesia during surgical procedures and labor and delivery[5].

Key Players in the Market

Several key players are driving the chloroprocaine hydrochloride injection market:

• Kaifu Pharmaceutical
• Haisi Pharma
• B. Braun Medical
• Fresenius Kabi
• Hikma Pharmaceuticals
• Harrow (with its FDA-approved IHEEZO™ ophthalmic gel)
• Sintetica SA (involved in various clinical trials and licensing agreements)[2][3].

Regional Analysis

North America

North America is a significant player in the global chloroprocaine hydrochloride injection market, driven by a robust economy, technological advancements, and a strong consumer base with high purchasing power. The United States and Canada are major contributors to this regional market[2].

Europe

Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries such as the United Kingdom, Germany, France, and Italy are key players in this region[2].

Asia-Pacific

The Asia-Pacific region is rapidly growing, driven by countries like China, Japan, India, and South Korea. This growth is attributed to a large population, rising disposable income, and increasing urbanization[2].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa represent emerging markets with opportunities and challenges. Economic fluctuations and political instability in some countries can impact market dynamics, but overall, these regions show promising growth potential[2].

Key Takeaways

• Chloroprocaine hydrochloride is a rapidly acting and short-duration local anesthetic, ideal for outpatient surgeries and procedures.
• The market is driven by increasing surgical procedures, advancements in medical technology, and a growing focus on pain management.
• Regulatory approvals and favorable reimbursement policies are supporting market growth.
• The global market is projected to grow from USD 18.58 billion in 2024 to USD 34.89 billion by 2031.
• Key players include Kaifu Pharmaceutical, Haisi Pharma, B. Braun Medical, Fresenius Kabi, Hikma Pharmaceuticals, Harrow, and Sintetica SA.

FAQs

1. What is the current market size and future growth prospects of the chloroprocaine hydrochloride injection market?

   • The market is anticipated to grow from USD 18.58 billion in 2024 to USD 34.89 billion by 2031, with a CAGR of 9.42%[2].

2. What are the key drivers of the chloroprocaine hydrochloride injection market?

   • The market is driven by the increasing number of surgical procedures, advancements in medical technology, growing focus on pain management, and favorable regulatory and reimbursement policies[2][5].

3. Which regions are significant contributors to the chloroprocaine hydrochloride injection market?

   • North America, Europe, and the Asia-Pacific region are significant contributors, with the Asia-Pacific region showing rapid growth due to its large population and rising disposable income[2].

4. What is the significance of IHEEZO™ in the chloroprocaine hydrochloride market?

   • IHEEZO™ is the first branded ocular anesthetic approved for the U.S. market in nearly 14 years, indicated for ocular surface anesthesia, and has received transitional pass-through reimbursement status from CMS[3][4].

5. Who are the key players in the chloroprocaine hydrochloride injection market?

   • Key players include Kaifu Pharmaceutical, Haisi Pharma, B. Braun Medical, Fresenius Kabi, Hikma Pharmaceuticals, Harrow, and Sintetica SA[2][3].

Sources

1. DrugPatentWatch: Generic CHLOROPROCAINE HYDROCHLORIDE INN equivalents and recent clinical trials.
2. OpenPR: Chloroprocaine Hydrochloride Injection Market Size, Share and Forecast.
3. Harrow Investors: U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3%.
4. Ophthalmology Times: Harrow announces transitional pass-through reimbursement status for chloroprocaine hydrochloride ophthalmic gel.
5. Proficient Market Insights: Global Chloroprocaine Hydrochloride Injection Market Research.