CLINICAL TRIALS PROFILE FOR VALDECOXIB

All Clinical Trials for valdecoxib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00115752 ↗	Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain	Completed	National Institute of Nursing Research (NINR)	Phase 2	2005-06-20	This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription. Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study. Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced. During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20 minutes, patients will rate the pain they feel by answering questions. If there is pain before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the study procedures are completed, patients will receive pain medication for pain after surgery. Patients will be monitored closely, because all drugs have side effects. Ketorolac is a nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a powerful narcotic drug that is safe at the dosage used in this study, but stomach upset, dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort from injecting the numbing medicine, infection, and bleeding. There may be discomfort from the sedative injected into the vein, and there may be bruising. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. There are no plans to give patients the results of genetic tests or questionnaires. Years of research may be needed before such information has the chance to become meaningful.
NCT00122096 ↗	Perioperative Inflammation and Cyclooxygenase 2 (COX-2)	Completed	Pfizer	Phase 4	2002-11-01	Surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response. The purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients treated with a COX-2 inhibitor.
NCT00092339 ↗	A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-08-01	The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00092300 ↗	A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-05-01	The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00021996 ↗	Valdecoxib in Treating Chronic Pain in Cancer Patients	Completed	Dana-Farber Cancer Institute	N/A	2001-01-01	RATIONALE: Valdecoxib may be effective in relieving chronic pain in cancer patients. It is not yet known if valdecoxib is effective in treating chronic pain. PURPOSE: Randomized clinical trial to study the effectiveness of valdecoxib in relieving chronic pain in cancer patients.

Clinical Trial Conditions for valdecoxib

Condition Name

Condition Name for valdecoxib
Intervention	Trials
Pain	10
Osteoarthritis	2
Postoperative Pain	2
Sprains and Strains	2

Condition MeSH

Condition MeSH for valdecoxib
Intervention	Trials
Pain, Postoperative	7
Sprains and Strains	3
Signs and Symptoms	3
Osteoarthritis, Knee	3

Clinical Trial Locations for valdecoxib

Trials by Country

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Trials by Country for valdecoxib
Location	Trials
United States	114
Brazil	22
Canada	12
Colombia	11
Japan	9

Trials by US State

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−

Trials by US State for valdecoxib
Location	Trials
Pennsylvania	7
Florida	6
California	6
Arizona	6
Maryland	6

Clinical Trial Progress for valdecoxib

Clinical Trial Phase

Clinical Trial Phase for valdecoxib
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for valdecoxib
Clinical Trial Phase	Trials
Completed	24
Terminated	4
Unknown status	1

Clinical Trial Sponsors for valdecoxib

Sponsor Name

Sponsor Name for valdecoxib
Sponsor	Trials
Pfizer	20
Merck Sharp & Dohme Corp.	3
Fundação de Amparo à Pesquisa do Estado de São Paulo	2

Sponsor Type

Sponsor Type for valdecoxib
Sponsor	Trials
Industry	23
Other	12
NIH	3

Valdecoxib: Clinical Trials, Market Analysis, and Projections

Introduction to Valdecoxib

Valdecoxib, marketed under the brand name Bextra, is a selective COX-2 inhibitor that was approved by the U.S. Food and Drug Administration (FDA) in 2004 for the relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA)[1].

Clinical Trials and Efficacy

Clinical trials comparing valdecoxib to conventional NSAIDs and placebo have demonstrated its efficacy in treating OA and RA. These trials, lasting 3-6 months, showed that valdecoxib was as effective as conventional NSAIDs in treating the signs and symptoms of these conditions but with a significantly lower risk of serious gastrointestinal side effects[1].

A multi-center, randomized, double-blind, placebo-controlled trial compared the efficacy and safety of valdecoxib with the conventional NSAID naproxen and placebo in treating RA. The results indicated that valdecoxib, at doses of 10 mg, 20 mg, and 40 mg once daily, produced significant improvements in the American College of Rheumatology-Responder Index (ACR-20) compared to placebo. The efficacy of valdecoxib was similar to that of naproxen, and all doses of valdecoxib were well tolerated[4].

Safety Profile

Valdecoxib has been noted for its favorable safety profile, particularly in reducing the risk of gastrointestinal side effects. In placebo-controlled trials, the incidence of endoscopically-detected gastroduodenal ulcers in patients treated with valdecoxib was similar to those treated with placebo, highlighting its gastrointestinal safety compared to traditional NSAIDs[1].

However, it is important to note that valdecoxib, like other COX-2 inhibitors, carries cardiovascular risks and should not be taken by women in their third trimester of pregnancy or by individuals who have had allergic reactions after taking aspirin[1].

Market Analysis

The COX-2 selective NSAIDs market, which includes valdecoxib, has been growing steadily. In 2023, the market size was USD 7.83 billion, and it increased to USD 8.19 billion in 2024. The market is projected to continue growing at a Compound Annual Growth Rate (CAGR) of 5.42%, reaching USD 11.33 billion by 2030[2].

Drivers of Market Growth

• Increasing Prevalence of Chronic Diseases: The growing need for pain management in chronic diseases such as osteoarthritis and rheumatoid arthritis is a significant driver of the market.
• Aging Population: An increasing aging population also contributes to the demand for effective pain management solutions.
• Advancements in Drug Delivery Systems: Recent advances in drug delivery systems and molecular targeting offer opportunities for innovation, including the development of novel formulations that minimize side effects and maximize therapeutic benefits[2].

Challenges

• Regulatory Policies: Stringent regulatory policies and the need for rigorous post-marketing surveillance are challenges faced by the market.
• Cardiovascular Risks: The long-term cardiovascular risks associated with certain COX-2 inhibitors, including valdecoxib, limit their widespread adoption[2].

Market Projections

Despite the challenges, the COX-2 selective NSAIDs market is expected to grow significantly. Here are some key projections:

• Market Size: The market is projected to reach USD 11.33 billion by 2030, driven by the increasing prevalence of chronic diseases and advancements in drug delivery systems[2].
• Personalized Medicine: The market is expected to benefit from advancements in personalized medicine, with a focus on balancing efficacy with safety. Strategic alliances and R&D endeavors focused on enhancing drug profiles are likely to drive growth[2].

Future Innovations and Opportunities

The market is dynamic, with several opportunities for innovation:

• Novel Formulations: The development of novel formulations that minimize side effects and maximize therapeutic benefits is a key area of innovation.
• Biomarkers and Customized Drug Regimens: Research into more precise biomarkers for inflammatory diseases could lead to customized drug regimens, driving market expansion.
• Complementary Therapies: Integrating COX-2 inhibitors with complementary therapies or pursuing advancements in biodegradable delivery mechanisms can spur business growth[2].

Key Takeaways

• Efficacy and Safety: Valdecoxib has demonstrated efficacy similar to conventional NSAIDs but with a lower risk of gastrointestinal side effects.
• Market Growth: The COX-2 selective NSAIDs market is expected to grow significantly, driven by the increasing prevalence of chronic diseases and advancements in drug delivery systems.
• Challenges and Opportunities: Despite challenges such as regulatory policies and cardiovascular risks, the market offers opportunities for innovation in novel formulations, biomarkers, and complementary therapies.

FAQs

What is valdecoxib used for?

Valdecoxib is used for the relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA)[1].

What are the common side effects of valdecoxib?

The most common side effects of valdecoxib include headache, abdominal pain, upset stomach, and nausea[1].

Why was valdecoxib preferred over conventional NSAIDs in clinical trials?

Valdecoxib was preferred due to its lower risk of serious gastrointestinal side effects compared to conventional NSAIDs[1].

What is the projected market size of COX-2 selective NSAIDs by 2030?

The COX-2 selective NSAIDs market is projected to reach USD 11.33 billion by 2030[2].

What are the key drivers of the COX-2 selective NSAIDs market growth?

The key drivers include the increasing prevalence of chronic diseases, an aging population, and advancements in drug delivery systems[2].

Sources

1. FDA Approves Valdecoxib (Bextra) for Treatment in Osteoarthritis and Rheumatoid Arthritis - Hopkins Arthritis
2. COX-2 Selective NSAIDs Market Research Report 2025-2030 - GlobeNewswire
3. PrimeC Emerging Drug Insight and Market Forecast - DelveInsight
4. Efficacy and safety of valdecoxib in treating the signs and symptoms of rheumatoid arthritis - Oxford Academic
5. Celecoxib Market Size, Share, Growth, And Industry 2032 - Business Research Insights