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Last Updated: January 22, 2025

CLINICAL TRIALS PROFILE FOR ROXICODONE


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All Clinical Trials for Roxicodone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00726830 ↗ Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer Terminated National Cancer Institute (NCI) N/A 2009-03-01 RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.
NCT00726830 ↗ Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer Terminated M.D. Anderson Cancer Center N/A 2009-03-01 RATIONALE: Methadone, morphine, or oxycodone may help relieve pain caused by cancer. It is not yet known whether methadone is more effective than morphine or oxycodone in treating pain in patients with cancer. PURPOSE: This randomized clinical trial is studying methadone to see how well it works compared with morphine or oxycodone in treating pain in patients with cancer.
NCT00853216 ↗ Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodoneâ„¢ 30 mg Tablets Completed Mallinckrodt Phase 1 2003-01-01 The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available oxycodone tablet (Roxicodoneâ„¢ 30 mg, Roxane Laboratories, Inc.) in a test group of healthy subjects under fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Roxicodone

Condition Name

Condition Name for Roxicodone
Intervention Trials
Healthy 4
Pain 3
Fractures, Bone 1
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Condition MeSH

Condition MeSH for Roxicodone
Intervention Trials
Fractures, Bone 2
Pain, Postoperative 2
Neoplasms 2
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Clinical Trial Locations for Roxicodone

Trials by Country

Trials by Country for Roxicodone
Location Trials
United States 16
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Trials by US State

Trials by US State for Roxicodone
Location Trials
Missouri 3
California 2
Florida 2
Texas 2
West Virginia 1
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Clinical Trial Progress for Roxicodone

Clinical Trial Phase

Clinical Trial Phase for Roxicodone
Clinical Trial Phase Trials
Phase 4 6
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Roxicodone
Clinical Trial Phase Trials
Completed 10
Terminated 2
Recruiting 2
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Clinical Trial Sponsors for Roxicodone

Sponsor Name

Sponsor Name for Roxicodone
Sponsor Trials
Mallinckrodt 3
National Cancer Institute (NCI) 2
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for Roxicodone
Sponsor Trials
Other 14
Industry 8
NIH 3
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Oxycodone: Clinical Trials, Market Analysis, and Projections

Introduction to Oxycodone

Oxycodone, a potent opioid analgesic, is widely used for the management of moderate to severe pain. It is available in various formulations, including immediate-release and controlled-release tablets. Here, we will delve into the current clinical trials, market analysis, and future projections for oxycodone.

Clinical Trials Update

Pediatric Safety Study

One notable clinical trial is the "An Open-Label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-Release Tablets in Opioid Experienced Children from Ages 6 to 16 Years Old" conducted by Nemours Children's Health System. This study aims to investigate the safety, effectiveness, and dosage of oxycodone hydrochloride controlled-release tablets in pediatric patients with moderate to severe pain requiring opioid therapy.

  • Eligibility Criteria: Children aged 6-16 years who need around-the-clock opioid medication for at least two weeks, have taken opioids for at least five days before the study, and can swallow pills without chewing or crushing them.
  • Study Duration: The participation lasts about 5-6 weeks, including a screening period, treatment period, and follow-up period. Participants will have regular office visits and phone calls to monitor their condition[1].

Comparative Studies

Another significant study compares the effectiveness of oxycodone hydrochloride versus a combination of acetaminophen and codeine. This double-blind, randomized clinical trial assesses the pain relief efficacy of these medications in patients.

  • Methodology: Participants were prescribed either oxycodone hydrochloride or a combination of acetaminophen and codeine for a maximum of three weeks. The primary outcome was the mean daily pain score measured using the Numerical Pain Rating Scale (NRS)[4].

Market Analysis

Global Market Size and Growth

The global oxycodone market is expected to experience significant growth over the coming years. Here are some key market insights:

  • Market Size: The oxycodone market was valued at USD 10.39 billion in 2024 and is projected to exceed USD 25.87 billion by 2037, growing at a CAGR of over 7.2% during the forecast period[5].
  • Regional Dominance: North America currently dominates the oxycodone market, driven by the increasing number of patients suffering from cancers, osteoarthritis, and rheumatoid arthritis. However, the Asia Pacific region is expected to hold the largest market share by 2037 due to its aging population and government initiatives to raise awareness about oxycodone[3][5].

Market Drivers

Several factors are driving the growth of the oxycodone market:

  • Rising Incidence of Chronic Pain: Conditions such as cancer, rheumatoid arthritis, lower back pain, and fibromyalgia are increasing, leading to higher demand for oxycodone[2].
  • Post-Surgical Pain Management: The rise in the number of surgical procedures worldwide is translating into extensive use of oxycodone for post-surgical pain relief[3].
  • Unresponsiveness to Other Medications: The ineffectiveness of other pain medications has increased the prescription volumes of oxycodone, especially extended-release formulations[2].

Market Challenges

Despite the growth, the oxycodone market faces several challenges:

  • Side Effects: Common side effects such as constipation, sedation, euphoria, and breathing problems are likely to restrain market growth[3].
  • Regulatory Scrutiny: Opioid misuse and addiction have led to increased regulatory scrutiny, which can impact market dynamics[3].

Market Projections

Future Growth

The oxycodone market is projected to grow significantly due to several factors:

  • Increasing Demand for Pain Management: The need for enhanced pain management activities in healthcare settings is driving the demand for oxycodone hydrochloride[3].
  • Extended Release Formulations: The convenience and better compliance offered by extended-release oxycodone drugs are expected to fuel market growth[2].
  • Geographical Expansion: Companies are making efforts to reach unexplored geographies, creating awareness about the benefits of oxycodone hydrochloride for pain relief and relaxation post-surgery and for chronic ailments[3].

Regional Outlook

  • Asia Pacific: This region is expected to hold the largest market share by 2037, driven by the growing aged population and government initiatives to raise awareness about oxycodone[5].
  • North America: This region will continue to be a significant market due to the increasing number of cancer patients and the presence of large research institutes[5].

Key Statistics

  • Global Market Size by 2032: Expected to reach USD 8.29 billion with a CAGR of 5.4%[2].
  • Global Market Size by 2037: Projected to exceed USD 25.87 billion with a CAGR of over 7.2%[5].
  • Surgical Procedures: Approximately 313 million surgical procedures are performed every year, contributing to the increased use of oxycodone for post-surgical pain relief[3].

Expert Insights

"The increasing incidence of chronic pain diseases such as cancer, rheumatoid arthritis, and lower back pain is a primary contributor to the oxycodone market expansion. Additionally, the benefits associated with extended-release oxycodone drugs, such as better compliance and convenience, will continue to drive market growth."[2]

Illustrative Examples

  • Clinical Trial Example: The study by Nemours Children's Health System highlights the need for tailored opioid therapy in pediatric patients, underscoring the importance of safety and efficacy in this demographic[1].
  • Market Example: The significant growth projected in the Asia Pacific region due to the aging population and government initiatives demonstrates the potential for oxycodone in emerging markets[5].

Key Takeaways

  • Clinical Trials: Ongoing clinical trials focus on the safety and efficacy of oxycodone in various patient populations, including pediatric patients.
  • Market Growth: The global oxycodone market is expected to grow significantly driven by the increasing incidence of chronic pain and the need for effective post-surgical pain management.
  • Regional Dynamics: North America and the Asia Pacific region are key markets, with the latter expected to dominate by 2037.
  • Challenges: Despite growth, the market faces challenges such as side effects and regulatory scrutiny.

FAQs

What is the primary focus of the current clinical trials on oxycodone?

The primary focus is on the safety, effectiveness, and dosage of oxycodone hydrochloride in various patient populations, including pediatric patients and those requiring post-surgical pain relief.

What are the key drivers of the oxycodone market growth?

The key drivers include the rising incidence of chronic pain diseases, the need for enhanced pain management activities, and the benefits associated with extended-release oxycodone formulations.

Which region is expected to dominate the oxycodone market by 2037?

The Asia Pacific region is expected to hold the largest market share by 2037 due to its growing aged population and government initiatives to raise awareness about oxycodone.

What are the common side effects of oxycodone that could restrain market growth?

Common side effects include constipation, sedation, euphoria, and breathing problems, which are likely to restrain market growth.

How is the oxycodone market expected to grow in terms of market size by 2037?

The oxycodone market is projected to exceed USD 25.87 billion by 2037, growing at a CAGR of over 7.2% during the forecast period.

Sources

  1. Nemours Children's Health System. Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-Release Tablets.
  2. Polaris Market Research. Oxycodone Drugs Market Share, Size, Trends, Industry Analysis Report.
  3. Transparency Market Research. Oxycodone Hydrochloride Market Size & Share, Outlook, 2034.
  4. JAMA Network Open. Effectiveness of Oxycodone Hydrochloride (Strong Opioid) vs Combination Acetaminophen and Codeine.
  5. Research Nester. Oxycodone Market Size | Growth Analysis 2025-2037.

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