CLINICAL TRIALS PROFILE FOR CATAFLAM

All Clinical Trials for Cataflam

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00276419 ↗	Treatment of Breast Pain Using A Medication (Diclofenac) Applied to the Skin	Terminated	Mayo Clinic	Phase 2/Phase 3	2005-06-01	The study was a randomized, double-blinded, crossover trial of topical diclofenac and placebo (10 weeks of each) for the treatment of noncyclic breast pain.
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.
NCT00548678 ↗	Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers	Completed	Javelin Pharmaceuticals	Phase 1	2007-10-01	This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.
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.
NCT01812538 ↗	A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects	Completed	Hospira, Inc.	Phase 1	2009-05-01	This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular repolarization in healthy subjects compared to placebo. Other secondary objectives are as follows: - To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD). - To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations. - Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy subjects. - Provide additional safety information.
NCT01812538 ↗	A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects	Completed	Hospira, now a wholly owned subsidiary of Pfizer	Phase 1	2009-05-01	This study is conducted to evaluate the effectiveness of DIC075V on ventricular repolarization in healthy subjects compared to placebo after a single dose of DIC075V administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular repolarization in healthy subjects compared to placebo. Other secondary objectives are as follows: - To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD). - To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations. - Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy subjects. - Provide additional safety information.

Clinical Trial Conditions for Cataflam

Condition Name

Condition Name for Cataflam
Intervention	Trials
Healthy	3
Endoscopy	1
Surgical Scar-Related Breast Pain	1
Symptomatic Irreversible Pulpitis	1

Condition MeSH

Condition MeSH for Cataflam
Intervention	Trials
Pulpitis	3
Pain, Postoperative	2
Hemorrhage	1
Mastodynia	1

Clinical Trial Locations for Cataflam

Trials by Country

Trials by Country for Cataflam
Location	Trials
United States	4
Egypt	3
Jordan	1
Mexico	1
Thailand	1

Trials by US State

Trials by US State for Cataflam
Location	Trials
North Dakota	1
Florida	1
Maryland	1
Minnesota	1

Clinical Trial Progress for Cataflam

Clinical Trial Phase

Clinical Trial Phase for Cataflam
Clinical Trial Phase	Trials
Phase 4	2
Phase 2/Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Cataflam
Clinical Trial Phase	Trials
Completed	8
Unknown status	3
Not yet recruiting	3

Clinical Trial Sponsors for Cataflam

Sponsor Name

Sponsor Name for Cataflam
Sponsor	Trials
Cairo University	5
Javelin Pharmaceuticals	2
Manal El Namrawy	1

Sponsor Type

Sponsor Type for Cataflam
Sponsor	Trials
Other	12
Industry	7

Cataflam (Diclofenac Potassium): Clinical Trials, Market Analysis, and Projections

Introduction to Cataflam

Cataflam, also known as diclofenac potassium, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for the treatment of various pain and inflammatory conditions, including primary dysmenorrhea, mild to moderate pain, and the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults[4].

Clinical Trials Experience

Clinical trials involving Cataflam have provided valuable insights into its efficacy and safety profile. Here are some key points:

• Short-Term Trials: In clinical trials involving 718 patients treated with Cataflam for periods of 2 weeks or less, adverse reactions were reported less frequently compared to those treated for longer periods[1].
• Comparative Trials: A 6-month double-blind trial comparing Cataflam with diclofenac sodium delayed-release tablets and ibuprofen showed similar adverse reaction rates and nature among the three treatments[1].
• Monitoring: Clinical trials and postmarketing experiences highlight the importance of monitoring transaminases within 4 to 8 weeks after initiating treatment with diclofenac to ensure liver safety[1].

Market Analysis

Global Market Size and Growth

The diclofenac market, which includes Cataflam, is projected to grow significantly over the coming years.

• Forecast: By 2027, the diclofenac market is expected to reach $6.1 billion, growing at a Compound Annual Growth Rate (CAGR) of 3.9% from 2022 to 2027[3].
• Regional Dominance: North America held a dominant market share in 2021, primarily due to robust medical infrastructure and widespread knowledge of diclofenac usage. However, the Asia-Pacific region is expected to offer lucrative growth opportunities driven by medical advertisements and government support for medicinal developments[3].

Key Drivers of Growth

Several factors are driving the growth of the diclofenac market:

• Geriatric Population: The increasing burden of the geriatric population and their associated physical ailments, such as osteoarthritis and other inflammatory disorders, are significant drivers[3].
• Sports Injuries: The rise in sports-related injuries, particularly with increased government support for sporting events, is also contributing to market growth[3].
• Topical Solutions: The active rollout of topical diclofenac solutions for various sports-related ailments and injuries further boosts the market[3].

Market Segmentation

The diclofenac market is segmented based on administration routes and indications:

• Administration Routes: Oral, injection, topical solution, sprays, patches, eye-drops, and others. Topical solutions and sprays are particularly fast-growing segments[3].
• Indications: Osteoarthritis, ankylosing spondylitis, dysmenorrhea, rheumatoid arthritis, and other inflammatory conditions[3].

Challenges and Barriers

Despite the growth potential, the diclofenac market faces several challenges:

• Side Effects: Cases of unwanted side effects, such as thrombotic cardiovascular events, gastrointestinal effects, and potential for bleeding, ulceration, and perforation of the stomach or intestines, have hampered market growth[3].
• Regulatory Policies: Stringent regulatory policies, especially concerning cardiovascular risks associated with certain NSAIDs, limit their widespread adoption[5].

Competitive Landscape

The NSAID market, including diclofenac, is competitive with various formulations and brands:

• COX-2 Selective NSAIDs: While not directly related to Cataflam, the COX-2 selective NSAIDs market is growing, driven by the need for safer and more effective anti-inflammatory drugs. This market is expected to reach $11.33 billion by 2030, growing at a CAGR of 5.42% from 2023 to 2030[5].

Projections and Future Outlook

Market Growth Projections

• The diclofenac market is expected to continue growing, driven by the increasing prevalence of chronic diseases and a growing aging population. By 2027, the market is projected to reach $6.1 billion[3].

Geographical Expansion

• Asia-Pacific is set to offer significant growth opportunities due to robust medical advertisements and government support for medicinal developments. This region is expected to become a key market for diclofenac products[3].

Product Innovations

• The development of safer and more effective formulations, such as topical solutions and sprays, will continue to drive market growth. For example, diclofenac sprays are actively used to treat sports injuries, contributing to the market's expansion[3].

Key Takeaways

• Clinical Trials: Cataflam has been tested in various clinical trials, showing a similar safety and efficacy profile to other diclofenac formulations.
• Market Growth: The diclofenac market is projected to reach $6.1 billion by 2027, driven by the geriatric population and increasing sports injuries.
• Challenges: The market faces challenges from side effects and stringent regulatory policies.
• Geographical Expansion: Asia-Pacific is expected to be a significant growth region.
• Product Innovations: Topical solutions and sprays are key growth drivers.

Frequently Asked Questions (FAQs)

1. What is Cataflam used for?

Cataflam, or diclofenac potassium, is used for the treatment of primary dysmenorrhea, mild to moderate pain, and the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in adults[4].

2. What are the common side effects of Cataflam?

Common side effects include gastrointestinal effects such as bleeding, ulceration, and perforation of the stomach or intestines, as well as thrombotic cardiovascular events like myocardial infarction and stroke[3].

3. How is the diclofenac market segmented?

The diclofenac market is segmented based on administration routes (oral, injection, topical solution, etc.) and indications (osteoarthritis, ankylosing spondylitis, dysmenorrhea, etc.)[3].

4. What drives the growth of the diclofenac market?

The growth is driven by the increasing burden of the geriatric population, sports-related injuries, and the development of safer and more effective formulations like topical solutions and sprays[3].

5. What are the challenges facing the diclofenac market?

The market faces challenges from unwanted side effects, stringent regulatory policies, and the cardiovascular risks associated with certain NSAIDs[3][5].

Cited Sources:

1. RxList: Cataflam (Diclofenac Potassium Immediate-Release Tablets) - RxList.
2. Drug-Dev: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. IndustryARC: Diclofenac Market Size Report, 2022-2027.
4. FDA: 204592Orig1s000PharmR.pdf.
5. GlobeNewswire: COX-2 Selective NSAIDs Market Research Report 2025-2030.