CLINICAL TRIALS PROFILE FOR CHLORZOXAZONE

All Clinical Trials for CHLORZOXAZONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00330434 ↗	Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	N/A	2005-12-01	The two purposes of this study are 1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has 1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and 2. on the stimulant effect of bupropion and 2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has 1. on the blood levels of bupropion and its major breakdown products in the blood and 2. on the stimulant effect of bupropion. Two groups of volunteers will be recruited for this study: 1. volunteers who drink moderate to heavy amounts of alcohol frequently and 2. volunteers who usually do not drink alcohol. Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.
NCT01187862 ↗	Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes	Completed	University Hospital, Basel, Switzerland	Phase 1	2010-07-01	The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
NCT01342341 ↗	Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake	Completed	University of California, San Francisco	Phase 4	2011-04-01	The overall goals of this study are to (1) expand knowledge about interactions of chlorzoxazone with alcohol by assessing the effects of chlorzoxazone compared to placebo in moderate and heavy social alcohol users and (2) to compare the effects of chlorzoxazone on visual cue induced alcohol craving to placebo in moderate to heavy social alcohol users.
NCT01933542 ↗	The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2013-08-01	Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
NCT01933542 ↗	The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery	Completed	Rigshospitalet, Denmark	Phase 4	2013-08-01	Chlorzoxazone is a centrally acting muscle relaxant used to treat muscle spasm and the resulting pain or discomfort. It acts on the spinal cord by depressing reflexes. Our purpose is to investigate the effect of chlorzoxazone on moderate to severe postoperative pain after spine surgery. Our hypothesis is that chlorzoxazone can reduce postoperative pain and reduce opioidconsumption and side effects compared to placebo.
NCT02291666 ↗	Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects	Completed	Canadian Institutes of Health Research (CIHR)	Phase 4	2015-04-01	Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. In our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and macro-vascular complications and inadequately controlled T2D due to high intersubject variability in drug disposition and action. Characterization of the effects of T2D on drug metabolism capacity will be performed using a cocktail of CYP450 probe drugs. CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2), bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1). Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated and compared between three groups of subjects. Other co-variables to be studied include T2D biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and inflammatory markers. Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the activity of major CYP450s. Moreover, this project will indicate to us whether glycemic control should be considered as a covariate of intersubject variability in drug metabolism capacity.
NCT02291666 ↗	Evaluation of CYP450 Activities in Diabetic Patients vs. Non-diabetic Subjects	Completed	Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4	2015-04-01	Type 2 diabetes (T2D) could modulate CYP450 activities involved in drug-metabolism and cardiovascular homeostasis. We propose to carry out, for the first time, a comprehensive characterization of the effects of T2D on the expression and activity of major CYP450s. In our studies, patients with T2D will be studied since hyperglycaemia and/or hyperinsulinemia are believed to modulate CYP450s. This vicious cycle puts patients at risk of micro- and macro-vascular complications and inadequately controlled T2D due to high intersubject variability in drug disposition and action. Characterization of the effects of T2D on drug metabolism capacity will be performed using a cocktail of CYP450 probe drugs. CYP450 phenotype will be determined in 3 groups of patients (n=126 patients): 1) 42 T2D patients with good glycemic control; 2) 42 T2D patients with poor glycemic control; and 3) 42 non-T2D healthy subjects following a single oral administration of a cocktail of CYP450 probe drugs. Subjects will receive the CRCHUM-MT cocktail consisting of caffeine (CYP1A2), bupropion (CYP2B6), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan (CYP2D6), midazolam (CYP3A4/5) and chlorxozaxone (which will be administered separately) (CYP2E1). Serial blood samples will be drawn and urine collected. Metabolic ratios will be calculated and compared between three groups of subjects. Other co-variables to be studied include T2D biomarkers at baseline (glucose, insulin, HbA1c), medications, genetic polymorphisms and inflammatory markers. Our cocktail probe drug approach should allow us to demonstrate the effects of T2D on the activity of major CYP450s. Moreover, this project will indicate to us whether glycemic control should be considered as a covariate of intersubject variability in drug metabolism capacity.

Clinical Trial Conditions for CHLORZOXAZONE

Condition Name

Condition Name for CHLORZOXAZONE
Intervention	Trials
Pharmacokinetics	2
Alcohol Abuse	1
Osteoarthritis of Hip	1
Alcohol Drinking	1

Condition MeSH

Condition MeSH for CHLORZOXAZONE
Intervention	Trials
Diabetes Mellitus, Type 2	1
Obesity, Morbid	1
Pain, Postoperative	1
Obesity	1

Clinical Trial Locations for CHLORZOXAZONE

Trials by Country

Trials by Country for CHLORZOXAZONE
Location	Trials
United States	3
Denmark	2
Switzerland	1
Germany	1
Canada	1

Trials by US State

Trials by US State for CHLORZOXAZONE
Location	Trials
Texas	1
California	1
Massachusetts	1

Clinical Trial Progress for CHLORZOXAZONE

Clinical Trial Phase

Clinical Trial Phase for CHLORZOXAZONE
Clinical Trial Phase	Trials
Phase 4	4
Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for CHLORZOXAZONE
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for CHLORZOXAZONE

Sponsor Name

Sponsor Name for CHLORZOXAZONE
Sponsor	Trials
University Hospital, Basel, Switzerland	1
The Institute of Molecular and Translational Medicine, Czech Republic	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for CHLORZOXAZONE
Sponsor	Trials
Other	17
Industry	2
NIH	1

CHLORZOXAZONE Market Analysis and Financial Projection

Chlorzoxazone: Clinical Trials, Market Analysis, and Projections

Introduction to Chlorzoxazone

Chlorzoxazone is a muscle relaxant commonly used to treat muscle spasms and musculoskeletal pain. It has been a preferred choice for doctors due to its effectiveness and relatively low side-effect profile. Here, we will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Perioperative Use in Orthopedic Surgery

A clinical trial (EudraCT Number 2015-001214-10) investigated the analgetic effect of perioperative chlorzoxazone in patients undergoing total hip or knee arthroplasty. The trial was a double-blind study where patients received either 250 mg of chlorzoxazone or a placebo three times a day for the first seven days post-surgery. The main objective was to assess the need for supplementary analgesics and the experience of pain after surgery.

• Results: The trial found no significant difference in the need for supplementary analgesics or pain experience between the chlorzoxazone and placebo groups. However, the trial ensured that any discomfort was managed with necessary treatments, and no non-serious adverse events were recorded[1].

Acute Pain After Spine Surgery

Another study published in the Acta Anaesthesiologica Scandinavica explored the effect of chlorzoxazone on acute pain after spine surgery. In this blinded study, 110 patients were randomly assigned to receive either 500 mg of oral chlorzoxazone or a placebo. The primary outcome was pain during mobilization 2 hours after the intervention.

• Results: The study found no significant difference in pain during mobilization or at rest between the chlorzoxazone and placebo groups. There was also no significant difference in opioid consumption or adverse effects. This led to the conclusion that chlorzoxazone did not demonstrate an analgesic effect in patients with acute pain after spine surgery[3].

Market Analysis

Market Growth and Projections

The chlorzoxazone market is expected to experience significant growth driven by several key factors:

• Increasing Demand for Non-Opioid Solutions: Amid the global opioid crisis, healthcare providers are increasingly prescribing muscle relaxants like chlorzoxazone due to their lower risk of dependency. This shift towards safer pain relief options is driving the market forward[2][4].

• Rising Healthcare Expenditure and Aging Population: The growing aging population and increasing incidents of musculoskeletal disorders are contributing to the growth of the chlorzoxazone market. Regions such as North America, Europe, and Asia-Pacific are leading this demand due to high healthcare standards and widespread healthcare access[2][4].

• Innovations in Formulations: The development of more effective formulations, including extended-release tablets, is enhancing the drug’s usability and patient adherence. New drug delivery methods are being researched to improve absorption rates and reduce side effects, making chlorzoxazone an even more attractive option[2].

Market Size and CAGR

The chlorzoxazone market is projected to register a Compound Annual Growth Rate (CAGR) of over 5% from 2023 to 2031. This growth is driven by the increasing prevalence of musculoskeletal disorders and a growing preference for non-opioid alternatives. The market is expected to see a substantial increase in value, with analysts predicting a steady rise in market share[2][4].

Distribution Channels and Regional Outlook

The market is segmented by form (tablets), distribution channels (hospital pharmacies, retail pharmacies, online pharmacies), and region. Key regions such as North America, Europe, and Asia-Pacific are expected to lead the demand due to advancements in healthcare and a rising focus on non-opioid treatments[2][4].

Innovations and Future Trends

Extended-Release Formulations

The continued development of extended-release formulations of chlorzoxazone is a significant trend. These formulations improve absorption rates, provide longer-lasting relief, and potentially reduce side effects, making chlorzoxazone more appealing for treating musculoskeletal pain[2].

New Drug Delivery Methods

Ongoing research aims to develop more effective delivery methods to enhance patient adherence and reduce side effects. This includes innovations in tablet formulations and other delivery systems that could further boost the market for chlorzoxazone[2].

Strategic Partnerships and Consolidation

Major pharmaceutical companies are investing in the chlorzoxazone market by forming strategic partnerships and acquiring smaller firms specializing in pain relief medications. This consolidation is driving new clinical trials and regulatory approvals, leading to innovative treatments in the pain management space[2].

Key Takeaways

• Clinical Trials: Recent trials have shown mixed results, with some indicating no significant analgesic effect in certain surgical contexts, while others highlight the drug's safety and efficacy in managing musculoskeletal pain.
• Market Growth: The chlorzoxazone market is expected to grow significantly, driven by the demand for non-opioid pain management solutions, rising healthcare expenditure, and an aging population.
• Innovations: Extended-release formulations and new drug delivery methods are enhancing the drug’s usability and patient adherence.
• Regional Outlook: North America, Europe, and Asia-Pacific are leading the demand due to high healthcare standards and a focus on non-opioid treatments.

FAQs

What is chlorzoxazone used for?

Chlorzoxazone is primarily used to treat muscle spasms and musculoskeletal pain by relaxing the muscles and alleviating associated pain.

Is chlorzoxazone effective for acute pain after surgery?

Clinical trials have shown mixed results. For example, one study found no significant analgesic effect of chlorzoxazone in patients with acute pain after spine surgery, while another trial did not show a significant difference in pain management post-orthopedic surgery[1][3].

What are the key drivers of the chlorzoxazone market growth?

The market growth is driven by the increasing demand for non-opioid pain management solutions, rising healthcare expenditure, a growing aging population, and innovations in drug formulations and delivery methods[2][4].

Which regions are leading the demand for chlorzoxazone?

North America, Europe, and Asia-Pacific are leading the demand due to high healthcare standards, widespread healthcare access, and a rising focus on non-opioid treatments[2][4].

Are there any new innovations in chlorzoxazone formulations?

Yes, there are ongoing developments in extended-release formulations and new drug delivery methods aimed at improving absorption rates, reducing side effects, and enhancing patient adherence[2].

Sources

1. Clinical Trial Results: "Analgetic effect of perioperative klorzoxazon at total hip or knee arthroplasty" - EU Clinical Trials Register[1].
2. Market Research Intellect: "Chlorzoxazone Tablets Market Set to Revolutionize Pain Relief in 2024"[2].
3. PubMed: "The effect of chlorzoxazone on acute pain after spine surgery. A randomized, double-blind, placebo-controlled trial"[3].
4. FutureWise Research: "Chlorzoxazone Market By Form, By Distribution Channel and By Region"[4].