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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR CELECOXIB

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Clinical Trials for Celecoxib

Trial ID Title Status Sponsor Phase 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 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 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 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.
NCT00005878 Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.
NCT00005878 Celecoxib to Prevent Cancer in Patients With Barrett's Esophagus Completed Sidney Kimmel Comprehensive Cancer Center Phase 2 RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing cancer in patients with Barrett's esophagus. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have Barrett's esophagus.
NCT00006124 Celecoxib in Treating Patients With Bladder Cancer Completed National Cancer Institute (NCI) Phase 2/Phase 3 This randomized phase IIb/III trial is studying celecoxib to see how well it works in preventing disease recurrence in patients who have bladder cancer. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of bladder cancer
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Celecoxib

Condition Name

Condition Name for Celecoxib
Intervention Trials
Osteoarthritis 33
Lung Cancer 22
Colorectal Cancer 19
Breast Cancer 18
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Condition MeSH

Condition MeSH for Celecoxib
Intervention Trials
Osteoarthritis 66
Colorectal Neoplasms 34
Osteoarthritis, Knee 33
Lung Neoplasms 27
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Clinical Trial Locations for Celecoxib

Trials by Country

Trials by Country for Celecoxib
Location Trials
Canada 82
United Kingdom 68
Japan 54
Brazil 46
Mexico 26
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Trials by US State

Trials by US State for Celecoxib
Location Trials
Texas 58
New York 57
California 54
Pennsylvania 49
Illinois 48
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Clinical Trial Progress for Celecoxib

Clinical Trial Phase

Clinical Trial Phase for Celecoxib
Clinical Trial Phase Trials
Phase 4 91
Phase 3 82
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Celecoxib
Clinical Trial Phase Trials
Completed 223
Recruiting 58
Terminated 48
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Clinical Trial Sponsors for Celecoxib

Sponsor Name

Sponsor Name for Celecoxib
Sponsor Trials
National Cancer Institute (NCI) 92
Pfizer 75
M.D. Anderson Cancer Center 11
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Sponsor Type

Sponsor Type for Celecoxib
Sponsor Trials
Other 402
Industry 159
NIH 108
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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Moodys
Fish and Richardson
Cipla
Merck
Chinese Patent Office
Argus Health
Johnson and Johnson
McKesson

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