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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR CELECOXIB


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505(b)(2) Clinical Trials for Celecoxib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00177853 ↗ Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Terminated Pharmacia and Upjohn Phase 1 2006-12-01 The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination NCT00177853 ↗ Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer Terminated University of Pittsburgh Phase 1 2006-12-01 The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination NCT00230399 ↗ Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer Completed University of Michigan Cancer Center Phase 2 2003-06-01 This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Celecoxib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001693 ↗ Phase I-II Multiple-Dose Safety and Efficacy Study of a Selective Inhibitor of Cyclooxygenase - 2 (SC-58635) in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients and Carriers Completed National Cancer Institute (NCI) Phase 1 1998-03-01 This is a randomized, placebo-controlled Phase I/II multi-center trial, of the safety and efficacy of Celecoxib in a cohort of 81 HNPCC subjects and gene carriers. The three proposed intervention arms are: Celecoxib (to be provided by Searle) will be administered at 200mg p.o. BID x 12 months or 400mg p.o. BID x 12 months vs. Placebo p.o. BID x 12 months. Assessment of endoscopic and tissue-based biomarker endpoints will be conducted at baseline and 12 months on study drug or placebo. Patients that present with polyps at baseline will undergo a month 4 endoscopy. Plasma drug trough samples for pharmacokinetic analyses will be collected at baseline and month 12. NCI-Chemoprevention Branch will coordinate the efforts and activities of all sites. Safety monitoring will occur via in-patient interviews with exams at month twelve; symptom questionnaires completed at baseline, months one, four, eight and twelve; blood and urinalysis at baseline and at months one, four, eight and twelve. A post-administration telephone call to evaluate side effect resolution will occur at months 13-14 for patients who have unresolved adverse events at the end of month 12.
NCT00001955 ↗ Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions) Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1999-12-01 This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory drugs for relieving pain and improving jaw function in patients with temporomandibular disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept (Enbrel). The Food and Drug Administration has approved both of these drugs for treating certain forms of arthritis. Patients between the ages of 18 and 65 years with painful jaw joint conditions may be eligible for this study. Candidates will complete several written questionnaires about their jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic resonance imaging. Patients will rate the quality and intensity of their pain before beginning treatment. At certain periods during the study, they will also keep a pain diary, twice a day recording the intensity and magnitude of their pain. Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or 3) a placebo (inactive pill) twice a day by mouth. Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients in this group will also undergo two aspirations of fluid from the jaw joint - once before treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be analyzed for inflammatory processes in the joint. All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD physical examination, laboratory and X-ray tests as required. The pain diary and questionnaires will be collected at this visit.
NCT00005094 ↗ Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps Completed National Cancer Institute (NCI) Phase 3 2000-03-01 Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer. This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Celecoxib

Condition Name

Condition Name for Celecoxib
Intervention Trials
Osteoarthritis 36
Colorectal Cancer 24
Lung Cancer 23
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Condition MeSH

Condition MeSH for Celecoxib
Intervention Trials
Osteoarthritis 75
Pain, Postoperative 41
Colorectal Neoplasms 40
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Clinical Trial Locations for Celecoxib

Trials by Country

Trials by Country for Celecoxib
Location Trials
United Kingdom 131
Canada 94
Japan 59
Brazil 47
China 34
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Trials by US State

Trials by US State for Celecoxib
Location Trials
New York 74
Texas 72
California 65
Illinois 55
Pennsylvania 55
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Clinical Trial Progress for Celecoxib

Clinical Trial Phase

Clinical Trial Phase for Celecoxib
Clinical Trial Phase Trials
Phase 4 111
Phase 3 95
Phase 2/Phase 3 13
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Clinical Trial Status

Clinical Trial Status for Celecoxib
Clinical Trial Phase Trials
Completed 317
Terminated 65
Unknown status 63
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Clinical Trial Sponsors for Celecoxib

Sponsor Name

Sponsor Name for Celecoxib
Sponsor Trials
National Cancer Institute (NCI) 97
Pfizer 77
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 35
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Sponsor Type

Sponsor Type for Celecoxib
Sponsor Trials
Other 557
Industry 243
NIH 118
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Celecoxib: Clinical Trials, Market Analysis, and Projections

Introduction to Celecoxib

Celecoxib, a selective COX-2 inhibitor, is widely used for its anti-inflammatory and analgesic properties, particularly in managing conditions such as arthritis, acute pain, and dysmenorrhea. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Lymphangioleiomyomatosis (LAM) Trial

The COLA trial, a phase I safety study, investigated the use of celecoxib in patients with LAM. This trial established the safety of celecoxib at a dose of 200 mg orally daily. The study focused on treatment-naïve patients who did not require mTORC1 inhibitors and evaluated safety, lung function, quality of life, and other secondary endpoints. While the trial confirmed the safety of celecoxib, larger phase II/III trials are necessary to determine its effectiveness, particularly in patients with high VEGF-D levels[1].

Breast Cancer Trial (REACT)

The REACT trial examined the efficacy of celecoxib in preventing the recurrence of HER2-negative breast cancer. This double-blinded, randomized trial involved 2,639 women who received either celecoxib or a placebo for two years following surgery and other treatments. The results indicated that celecoxib did not reduce the risk of breast cancer recurrence. However, the trial suggested that longer treatment durations or higher doses might be more effective, although further trials are needed to confirm this[4].

Juvenile Rheumatoid Arthritis (JRA) Trial

A clinical study (Study #195) compared the efficacy and safety of celecoxib suspension to naproxen suspension in patients with JRA. This 12-week, randomized, double-blind trial found that celecoxib was effective in managing JRA symptoms with a favorable safety profile. The study also explored the pharmacokinetics of celecoxib in pediatric patients, guiding dosing recommendations based on body weight[3].

Market Analysis

Market Size and Growth

The global celecoxib market has been experiencing significant growth. As of 2023, the market size was valued at USD 1.64 billion and is projected to reach USD 2.87 billion by 2031, growing at a CAGR of 8.8% during the forecast period. This growth is driven by the increasing need to treat osteoarthritis and acute pain, as well as the preference for COX-2 selective agents due to their safer gastrointestinal profile compared to traditional NSAIDs[2][5].

Market Segmentation

The celecoxib market is segmented into various categories, including prescription medications and over-the-counter (OTC) formulations. The prescription segment dominates the market, driven by the therapeutic efficacy and safety profile of celecoxib in managing chronic pain conditions and arthritis. The market is also segmented by end-users, including hospitals, clinics, and homecare settings, reflecting the diverse environments where celecoxib is administered[2].

Geographical Distribution

Geographically, the celecoxib market is significant in North America, particularly the United States, due to a strong healthcare infrastructure and high prevalence of chronic pain disorders. Europe, with countries like Germany, France, and the UK, also has a substantial market share, influenced by stringent regulatory environments. The Asia-Pacific region, especially countries like China and India, is witnessing rapid growth due to increasing healthcare expenditure and expanding medical facilities[2].

Advancements and Trends

Drug Formulations

Advancements in drug formulations are a key driver of the celecoxib market. The development of new formulations, such as suspensions and capsules, has improved the bioavailability and patient compliance. For instance, studies have shown that celecoxib capsules and suspensions have similar bioavailability profiles, making them interchangeable in certain clinical settings[3].

Safety Profile

Celecoxib's safety profile, particularly its reduced risk of gastrointestinal side effects compared to traditional NSAIDs, continues to be a significant advantage. Clinical trials and real-world data have reinforced its safety, making it a preferred choice for long-term pain management and use in patients at risk of gastric complications[2][4].

Future Projections

Market Expansion

The celecoxib market is expected to continue its growth trajectory, driven by increasing demand for safer pain management options and the expanding geriatric population. The Asia-Pacific and Latin American regions are anticipated to be key growth areas due to improving healthcare infrastructure and rising healthcare expenditure[2][5].

Research and Development

Future research is likely to focus on exploring celecoxib's potential in other therapeutic areas, such as its use in combination therapies or in different patient populations. The ongoing need for effective and safe pain management solutions will continue to drive innovation in celecoxib formulations and dosing regimens[1][4].

Key Takeaways

  • Clinical Trials: Recent trials have established the safety of celecoxib in various conditions, but larger trials are needed to confirm its effectiveness.
  • Market Growth: The celecoxib market is projected to grow significantly, driven by its safety profile and increasing demand for pain management solutions.
  • Geographical Distribution: North America and Europe are current market leaders, with the Asia-Pacific region showing promising growth.
  • Advancements: New formulations and a favorable safety profile are key drivers of the market.
  • Future Projections: The market is expected to expand, with a focus on new therapeutic areas and patient populations.

Frequently Asked Questions

What is the current market size of celecoxib and its projected growth?

The global celecoxib market size was valued at USD 1.64 billion in 2023 and is projected to reach USD 2.87 billion by 2031, growing at a CAGR of 8.8% during the forecast period[2][5].

What are the primary drivers of the celecoxib market?

The primary drivers include the increasing need to treat osteoarthritis and acute pain, as well as the preference for COX-2 selective agents due to their safer gastrointestinal profile[2][5].

Which regions are expected to see significant growth in the celecoxib market?

The Asia-Pacific region, particularly countries like China and India, and Latin America are expected to see significant growth due to improving healthcare infrastructure and rising healthcare expenditure[2].

What are the key advantages of celecoxib over traditional NSAIDs?

Celecoxib offers a reduced risk of gastrointestinal side effects and a favorable safety profile, making it a preferred choice for long-term pain management[2][4].

Are there any ongoing or planned clinical trials for celecoxib in new therapeutic areas?

While specific ongoing trials are not detailed here, future research is likely to explore celecoxib's potential in other therapeutic areas and patient populations, driven by the need for effective and safe pain management solutions[1][4].

Sources

  1. ERS Publications: "Celecoxib in lymphangioleiomyomatosis: results of a phase I clinical trial" - European Respiratory Journal[1].
  2. Verified Market Research: "Celecoxib Market Size, Share, Trends & Forecast" - Verified Market Research[2].
  3. FDA: "N20998S021 Celecoxib Clinpharm BPCA" - FDA[3].
  4. Cancer Research UK: "A trial looking at celecoxib for women with breast cancer (REACT)" - Cancer Research UK[4].
  5. Business Research Insights: "Celecoxib Market Size, Share, Growth, And Industry 2032" - Business Research Insights[5].

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