CLINICAL TRIALS PROFILE FOR DICLOFENAC POTASSIUM

All Clinical Trials for Diclofenac Potassium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00474136 ↗	Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium	Completed	Javelin Pharmaceuticals	Phase 1	2007-03-01	The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product.
NCT01009021 ↗	Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy	Completed	University of Sao Paulo	N/A	2008-03-01	The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation. Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.
NCT01019980 ↗	Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections	Terminated	Novartis Pharmaceuticals	Phase 4	2010-03-01	The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.
NCT01257126 ↗	Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection	Withdrawn	Novartis Pharmaceuticals	Phase 4	2011-04-01	This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.
NCT01458600 ↗	Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)	Completed	Mikael Lantz	Phase 4	2006-09-01	AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.
NCT01666197 ↗	Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain	Completed	Novartis	Phase 4	2012-08-01	The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
NCT01762306 ↗	Efficacy of Diclofenac on Pain During Endometrial Sampling	Unknown status	Mahidol University	N/A	2012-11-01	Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number of patients, the diagnosis of its cause is performed via fractional curettage under local anesthesia such as paracervical nerve block or intravenous meperidine. Pain is one of a common adverse effect of this procedure and this topic should be concerned by a responsible doctor. NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain control and is as effective as coxib in acute pain management. Because of its cost, easy accessible and easy administration, Diclofenac Potassium was selected to be used in this study. Its onset of action is about 1 hour and only one dose of this drug do not cause any serious side effects. The hypothesis of this study is that "Diclofenac Potassium has an additional effectiveness for acute pain control in patients undergoing fractional curettage under paracervical nerve block due to abnormal uterine bleeding" Double blind randomised controlled trial was performed in this study with 45 patients included in each group.

Clinical Trial Conditions for Diclofenac Potassium

Condition Name

Condition Name for Diclofenac Potassium
Intervention	Trials
Pain	4
Pulpitis - Irreversible	2
Symptomatic Irreversible Pulpitis	2
Healthy	2

Condition MeSH

Condition MeSH for Diclofenac Potassium
Intervention	Trials
Pulpitis	5
Migraine Disorders	3
Pain, Postoperative	3
Infection	2

Clinical Trial Locations for Diclofenac Potassium

Trials by Country

Trials by Country for Diclofenac Potassium
Location	Trials
United States	13
Egypt	9
Germany	2
Chile	1
Mexico	1

Trials by US State

Trials by US State for Diclofenac Potassium
Location	Trials
California	3
Texas	2
Alabama	2
New York	1
Florida	1

Clinical Trial Progress for Diclofenac Potassium

Clinical Trial Phase

Clinical Trial Phase for Diclofenac Potassium
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	3
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Diclofenac Potassium
Clinical Trial Phase	Trials
Completed	18
Not yet recruiting	6
Unknown status	4

Clinical Trial Sponsors for Diclofenac Potassium

Sponsor Name

Sponsor Name for Diclofenac Potassium
Sponsor	Trials
Cairo University	8
Depomed	4
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for Diclofenac Potassium
Sponsor	Trials
Other	22
Industry	18

Diclofenac Potassium: Clinical Trials, Market Analysis, and Projections

Introduction

Diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID), has been widely used for its potent analgesic and anti-inflammatory properties. This article delves into the recent clinical trials, market analysis, and future projections for diclofenac potassium, highlighting its efficacy, market trends, and potential growth.

Clinical Trials: Efficacy and Safety

Postoperative Pain Relief

A significant Cochrane systematic review compared the efficacy of diclofenac potassium and diclofenac sodium in relieving moderate to severe postoperative pain. The review included 18 randomized controlled trials involving 3,714 adults. It found that a single 50mg dose of diclofenac potassium was more effective than diclofenac sodium, with only two people needing to be treated for one person to achieve at least 50% pain relief compared to a placebo. In contrast, seven people would need to be treated with diclofenac sodium for the same level of pain relief[1].

Pharmacokinetics and Bioavailability

Studies have shown that diclofenac potassium has a faster rate of absorption compared to diclofenac sodium. For instance, the mean Tmax (time to reach maximum concentration) for diclofenac potassium was approximately 0.6 hours, significantly shorter than the 1.3 hours for diclofenac sodium. This faster absorption translates to quicker pain relief[3].

Long-Term Use and Quality of Life

A randomized, double-blind, double-dummy study compared the efficacy of prolonged-release diclofenac potassium (150 mg once daily) with immediate-release diclofenac potassium (50 mg three times a day) in patients with knee osteoarthritis. The study found that both formulations provided similar analgesic efficacy and improvements in quality of life, as measured by the WOMAC scale, over a 30-day period. However, the prolonged-release formulation offered the convenience of once-daily dosing[4].

Market Analysis

Market Size and Growth

The global diclofenac potassium market is expected to exhibit a healthy Compound Annual Growth Rate (CAGR) from 2023 to 2030. The market growth is driven by the increasing prevalence of pain and inflammation-related conditions, such as osteoarthritis and rheumatoid arthritis, and the growing demand for NSAIDs. The market size is projected to expand significantly, with North America and Europe being the major regional markets, followed by Asia Pacific and the Middle East & Africa[2][5].

Key Market Trends

• Growing Adoption in Combination Therapies: Diclofenac potassium is increasingly being used in combination with other drugs to enhance efficacy.
• Topical Formulations: There is a rising trend towards the use of topical formulations for localized pain relief.
• Long-Acting Formulations: The development of long-acting formulations aims to reduce the frequency of administration and improve patient compliance[2].
• Generic Market: Generic diclofenac potassium is gaining market share due to its lower cost and comparable efficacy[2].

Regulatory Scrutiny

Despite its benefits, diclofenac potassium faces regulatory scrutiny due to potential cardiovascular risks associated with its use. This has led to intensified monitoring and stricter prescribing guidelines, which could impact market growth[2].

Market Segmentation

The diclofenac potassium market is segmented based on application, type, and geography. The application segment includes osteoarthritis, rheumatoid arthritis, and other conditions. The type segment comprises tablets, capsules, injections, and topical formulations. Geographically, the market is dominated by North America and Europe, with significant growth potential in emerging markets[2][5].

Technological Advancements

Innovations in drug formulations and delivery systems are enhancing the convenience and effectiveness of diclofenac potassium treatment. For example, the development of prolonged-release formulations and topical applications is improving patient outcomes and compliance[2].

Potential Side Effects and Safety Concerns

While diclofenac potassium is generally well-tolerated, prolonged use can lead to side effects such as gastrointestinal bleeding and renal impairment. These safety concerns are being closely monitored by regulatory bodies and healthcare providers[2].

Expansion into Emerging Markets

The increasing healthcare expenditure and aging population in emerging economies are creating new opportunities for diclofenac potassium manufacturers. This expansion is expected to drive market growth in regions such as Asia Pacific and the Middle East & Africa[2].

Key Players

The market is dominated by several key players, including Jiangsu Lianshui, Beida Pharma, Dingyan Chemical, Nanjing Haina, Shengying Pharma, Dongtai Pharma, and Haobang Pharma. These companies are investing in research and development to enhance the efficacy and safety of diclofenac potassium formulations[5].

Conclusion

Diclofenac potassium remains a potent and effective NSAID for various pain and inflammatory conditions. Clinical trials have consistently shown its superiority over diclofenac sodium in terms of faster pain relief and better bioavailability. The market for diclofenac potassium is expected to grow significantly, driven by increasing demand, technological advancements, and expansion into emerging markets. However, regulatory scrutiny and potential side effects must be carefully managed to ensure continued market growth.

Key Takeaways

• Diclofenac potassium is more effective than diclofenac sodium for postoperative pain relief.
• The drug has a faster rate of absorption and higher bioavailability.
• Market growth is driven by increasing prevalence of pain and inflammation-related conditions.
• Technological advancements are enhancing the convenience and effectiveness of diclofenac potassium.
• Regulatory scrutiny and potential side effects are key concerns.
• Emerging markets offer significant growth opportunities.

FAQs

Q: What is the primary difference between diclofenac potassium and diclofenac sodium?

A: Diclofenac potassium has a faster rate of absorption and higher bioavailability compared to diclofenac sodium, leading to quicker pain relief[1][3].

Q: What are the common applications of diclofenac potassium?

A: Diclofenac potassium is commonly used for treating osteoarthritis, rheumatoid arthritis, and other pain and inflammation-related conditions[2][5].

Q: What are the potential side effects of prolonged use of diclofenac potassium?

A: Prolonged use of diclofenac potassium can lead to side effects such as gastrointestinal bleeding and renal impairment[2].

Q: Which regions are expected to drive the growth of the diclofenac potassium market?

A: North America and Europe are currently the major markets, but significant growth is expected in emerging economies such as Asia Pacific and the Middle East & Africa[2][5].

Q: What are the key trends in the diclofenac potassium market?

A: Key trends include the growing adoption in combination therapies, increasing use of topical formulations, development of long-acting formulations, and expansion into emerging markets[2].

Sources

1. NIHR Evidence: A single dose of diclofenac potassium is more effective for postoperative pain than the more commonly used diclofenac sodium.
2. Data Insights Market: Diclofenac Potassium's Role in Shaping Industry Trends 2025-2033.
3. FDA: CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW.
4. SCIRP: Randomized, Double-Blind, Double-Masked, Parallel Group Clinical Trial.
5. Verified Market Reports: Diclofenac Potassium Market Size, Trends & Forecast 2030.