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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR CELEBREX

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505(b)(2) Clinical Trials for Celebrex

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 NCT02641314 Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma Recruiting University of Cologne Phase 2 2016-10-01 Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients experience further progression. Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying vasculature and the interactions between Tumor and immune cells. The toxicity is expected to be low due to the low (but continuous) dosing of drugs. The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Celebrex

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00006299 Celebrex for Pain Relief After Oral Surgery Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1999-12-01 This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs. Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.
NCT00023660 Radiation Therapy Plus Celecoxib, Fluorouracil, and Cisplatin in Patients With Locally Advanced Cervical Cancer Completed National Cancer Institute (NCI) Phase 1/Phase 2 2001-08-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways and combining it with chemotherapy may kill more tumor cells. Celecoxib may slow the growth of cervical cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy plus celecoxib, fluorouracil, and cisplatin in treating patients who have locally advanced cervical cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Celebrex

Condition Name

Condition Name for Celebrex
Intervention Trials
Osteoarthritis 13
Osteoarthritis, Knee 8
Pain 7
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Condition MeSH

Condition MeSH for Celebrex
Intervention Trials
Osteoarthritis 27
Osteoarthritis, Knee 15
Breast Neoplasms 10
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Clinical Trial Locations for Celebrex

Trials by Country

Trials by Country for Celebrex
Location Trials
United States 381
United Kingdom 26
Canada 19
Korea, Republic of 13
Poland 8
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Trials by US State

Trials by US State for Celebrex
Location Trials
New York 26
Texas 21
Pennsylvania 20
Illinois 17
Florida 16
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Clinical Trial Progress for Celebrex

Clinical Trial Phase

Clinical Trial Phase for Celebrex
Clinical Trial Phase Trials
Phase 4 42
Phase 3 23
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Celebrex
Clinical Trial Phase Trials
Completed 56
Recruiting 26
Not yet recruiting 25
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Clinical Trial Sponsors for Celebrex

Sponsor Name

Sponsor Name for Celebrex
Sponsor Trials
Pfizer 27
National Cancer Institute (NCI) 15
Cairo University 4
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Sponsor Type

Sponsor Type for Celebrex
Sponsor Trials
Other 133
Industry 57
NIH 22
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