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Generated: February 15, 2019

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CLINICAL TRIALS PROFILE FOR VALDECOXIB

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Clinical Trials for Valdecoxib

Trial ID Title Status Sponsor Phase Summary
NCT00021996 Valdecoxib in Treating Chronic Pain in Cancer Patients Completed Dana-Farber Cancer Institute N/A 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.
NCT00092300 A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00092339 A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00115752 Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain Completed National Institute of Nursing Research (NINR) Phase 2 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 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.
NCT00122096 Perioperative Inflammation and Cyclooxygenase 2 (COX-2) Completed University of Washington Phase 4 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.
NCT00260325 Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers Completed National Institutes of Health (NIH) Phase 4 Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Valdecoxib

Condition Name

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

Condition MeSH for Valdecoxib
Intervention Trials
Signs and Symptoms 3
Osteoarthritis, Knee 3
Osteoarthritis 3
Sprains and Strains 3
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Clinical Trial Locations for Valdecoxib

Trials by Country

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

Trials by US State for Valdecoxib
Location Trials
Pennsylvania 7
Florida 6
California 6
Arizona 6
Maryland 6
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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
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Clinical Trial Status

Clinical Trial Status for Valdecoxib
Clinical Trial Phase Trials
Completed 23
Terminated 4
Recruiting 2
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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
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Sponsor Type

Sponsor Type for Valdecoxib
Sponsor Trials
Industry 23
Other 12
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Department of Justice
Healthtrust
AstraZeneca
Merck
Moodys
Teva
Fish and Richardson
US Army

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