CLINICAL TRIALS PROFILE FOR NABUMETONE

All Clinical Trials for nabumetone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00688961 ↗	Effects of Omacor and Aspirin on Platelet Function	Completed	Sanford Research	Early Phase 1	2007-06-01	Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.
NCT00864604 ↗	Single Dose Two-Way Crossover Fed Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers	Completed	Actavis Inc.	Phase 1	2007-04-01	The purpose of this study is to evaluate the relative bioavailability of two formulations of nabumetone tablets to establish their average bioequivalence
NCT00864968 ↗	Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers	Completed	Actavis Inc.	Phase 1	2007-02-01	The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
NCT01164813 ↗	Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2006-03-01	The purpose of this study is: - To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fasting conditions with a washout period of 14 days. - To monitor adverse events and ensure the safety of subjects.
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	GlaxoSmithKline	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.
NCT00610610 ↗	Paroxetine-CR (Paxil-CR) in the Treatment of Patients With Fibromyalgia Syndrome	Completed	Duke University	Phase 4	2002-01-01	Objective: Although there is a high comorbidity of depressive and/or anxiety disorders with fibromyalgia, information on the clinical implications of this comorbidity is limited. We investigated whether a history of depressive and/or anxiety disorders was associated with response to treatment in a double blind, randomized, placebo controlled trial of paroxetine controlled release (CR) in fibromyalgia. Method: One hundred and sixteen fibromyalgia subjects were randomized to receive paroxetine CR (dose 12.5-62.5 mg/day) or placebo for 12 weeks. The Mini International Neuropsychiatric Interview (M.I.N.I-plus) was used to ascertain current or past diagnoses of depressive and anxiety disorders. Patients with current depressive or anxiety disorders were excluded, but those with past diagnoses were enrolled in the trial. Subjective depression and anxiety were assessed using the Beck Depression Inventory (BDI) and the Beck Anxiety Inventory (BAI); subjects were excluded if they scored greater than 23 on the BDI. Health Status was determined using the 36-Item Short Form Health Survey (SF-36), the Sheehan Disability Scale (SDS), the Perceived Stress Scale (PSS) and the Pittsburgh Sleep Quality Index (PSQI). The primary outcome was treatment response defined as ≥ 25% reduction in the Fibromyalgia Impact Questionnaire (FIQ) score. Secondary outcomes included changes in scores on the Clinical Global Impression-Severity and Improvement (CGI-S and CGI-I respectively), the Visual Analogue Scale for Pain (VAS) scores and number of tender points.

Clinical Trial Conditions for nabumetone

Condition Name

Condition Name for nabumetone
Intervention	Trials
Healthy	5
Atrial Fibrillation	1
Fibromyalgia Syndrome	1
Osteoarthritis, Knee	1

Condition MeSH

Condition MeSH for nabumetone
Intervention	Trials
Myofascial Pain Syndromes	1
Fibromyalgia	1
Atrial Fibrillation	1
Osteoarthritis, Knee	1

Clinical Trial Locations for nabumetone

Trials by Country

+

−

Trials by Country for nabumetone
Location	Trials
United States	5
India	2
Brazil	1
Denmark	1

Trials by US State

+

−

Trials by US State for nabumetone
Location	Trials
North Carolina	3
South Dakota	1
Pennsylvania	1

Clinical Trial Progress for nabumetone

Clinical Trial Phase

Clinical Trial Phase for nabumetone
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	4
N/A	1

Clinical Trial Status

Clinical Trial Status for nabumetone
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for nabumetone

Sponsor Name

Sponsor Name for nabumetone
Sponsor	Trials
Actavis Inc.	2
Dr. Reddy's Laboratories Limited	2
University of Southern Denmark	1

Sponsor Type

Sponsor Type for nabumetone
Sponsor	Trials
Other	9
Industry	5

Nabumetone: Clinical Trials, Market Analysis, and Projections

Introduction to Nabumetone

Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to treat mild to moderate pain and relieve symptoms of arthritis, including osteoarthritis and rheumatoid arthritis. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Comparative Study with SAMe

A significant clinical trial compared the efficacy and tolerability of nabumetone with S-adenosylmethionine (SAMe) in Korean patients with knee osteoarthritis (OA). This 8-week, multicenter, randomized, double-blind, double-dummy Phase IV clinical trial involved 134 patients, with 67 receiving nabumetone 1000 mg once daily and 67 receiving SAMe 1200 mg/day (400 mg three times a day)[1].

• Pain Relief: Both treatments effectively reduced pain intensity from baseline, with no significant difference between the groups.
• Tolerability: There were no significant differences in adverse events, drug-related clinical or laboratory-determined adverse events, or discontinuations due to adverse events between the two treatments.
• Secondary End Points: Both groups showed significant improvements in functional class, patient's global assessment of disease status, physician's global assessment of response to therapy, and the Western Ontario and McMaster Universities (WOMAC) index.

This study indicates that nabumetone is as effective and tolerable as SAMe in treating knee OA in an Asian population.

Market Analysis

Global Market Trends

The global nabumetone market is expected to grow significantly over the next few years, driven by several key factors:

• Increasing Geriatric Population: The growing number of elderly individuals, who are more prone to arthritis, is a major driver of the market[3].
• Generic Pharmaceutical Production: The increasing production of generic pharmaceutical products, including nabumetone, is another significant factor contributing to market growth[3].
• Regional Growth: Developing regions are expected to provide vital growth opportunities due to the rising number of pharmaceutical startups and increasing healthcare needs[3].

Market Segmentation

The nabumetone market is segmented based on application and distribution channel:

• Application: The market is primarily segmented into osteoarthritis and rheumatoid arthritis. Other applications may include various inflammatory conditions[3].
• Distribution Channel: The market is segmented into online distribution, hospital and retail pharmacies, and hyper and super markets[3].

Regional Framework

The market is analyzed across various regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and South & Central America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics and growth opportunities[3].

Market Projections

Growth Rate and Market Size

The global nabumetone market is projected to grow at a significant Compound Annual Growth Rate (CAGR) from 2023 to 2031. The market size is expected to increase from US$ XX million in 2023 to US$ XX million by 2031[3].

Production and Consumption

The report on the global nabumetone API market provides insights into production, growth rate, market share by manufacturers, and consumption by region and country. It forecasts the market size and development potential for each region and its main countries from 2019 to 2030[2].

Competitive Landscape

The market is competitive, with several generic pharmaceutical companies producing nabumetone. The report provides profiles of key manufacturers, including their product descriptions, sales, revenue, price, gross margin, and recent developments. It also analyzes the competitive landscape, market positioning, and recent developments of major stakeholders[2].

Safety and Precautions

Common and Rare Side Effects

Nabumetone, like other NSAIDs, comes with several potential side effects:

• Common Side Effects: Acid or sour stomach, belching, bloated full feeling, mild diarrhea, and indigestion[4].
• Less Common Side Effects: Increased sweating, sleepiness or unusual drowsiness, and trouble sleeping[4].
• Rare Side Effects: Anxiety, burning or itching sensations, general feeling of discomfort or illness, and trembling or shaking of the legs or arms[4].

Serious Side Effects

Nabumetone can cause serious side effects, including:

• Cardiovascular Risks: Increased risk of heart attack or stroke, especially in people with pre-existing heart disease[4].
• Gastrointestinal Risks: Bleeding in the stomach or intestines, which can occur without warning signs[4].
• Skin Reactions: Serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis[4].

Key Takeaways

• Efficacy and Tolerability: Nabumetone is as effective and tolerable as SAMe in treating knee OA, based on clinical trials.
• Market Growth: The global nabumetone market is expected to grow significantly due to the increasing geriatric population and generic pharmaceutical production.
• Regional Opportunities: Developing regions offer vital growth opportunities due to rising healthcare needs and pharmaceutical startups.
• Safety Considerations: Nabumetone has potential side effects, including common, less common, and rare adverse events, as well as serious cardiovascular and gastrointestinal risks.

FAQs

What is Nabumetone used for?

Nabumetone is used to treat mild to moderate pain and relieve symptoms of arthritis, including osteoarthritis and rheumatoid arthritis[4].

What are the common side effects of Nabumetone?

Common side effects include acid or sour stomach, belching, bloated full feeling, mild diarrhea, and indigestion[4].

Is Nabumetone safe for elderly patients?

Elderly patients are more likely to have age-related kidney, stomach, or bowel problems, which may require caution when using nabumetone. However, no geriatric-specific problems have been demonstrated to limit its usefulness in the elderly[4].

What are the serious side effects of Nabumetone?

Serious side effects include increased risk of heart attack or stroke, bleeding in the stomach or intestines, and serious skin reactions such as exfoliative dermatitis and Stevens-Johnson syndrome[4].

How is the global Nabumetone market projected to grow?

The global nabumetone market is projected to grow at a significant CAGR from 2023 to 2031, driven by factors such as the increasing geriatric population and generic pharmaceutical production[3].

What regions offer the most growth opportunities for Nabumetone?

Developing regions, particularly in Asia-Pacific and other emerging markets, are expected to provide vital growth opportunities due to rising healthcare needs and the presence of pharmaceutical startups[3].