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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR ROFECOXIB

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Clinical Trials for Rofecoxib

Trial ID Title Status Sponsor Phase Summary
NCT00004845 A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study) Completed Alzheimer's Disease Cooperative Study (ADCS) Phase 2/Phase 3 The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00004845 A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study) Completed National Institute on Aging (NIA) Phase 2/Phase 3 The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00013650 Effects of an Anti-Inflammatory Drug in Alzheimer's Disease Completed National Institute of Mental Health (NIMH) Phase 1 The purpose of this study is to evaluate the effects of the drug cyclophosphamide (CY) on inflammation and immune responses in individuals with Alzheimer's Disease (AD). Inflammation and immunologic response appear to contribute to neurodegeneration in people with AD. In a process called gliosis, the brain immune cells microglia and astroglia undergo activation and possible proliferation, which promotes neuronal injury and death. Activated microglia and astroglia produce compounds that are cytotoxic to neurons, and they express molecules that greatly amplify immune and inflammatory processes in the brain. Excessive glial activation and proliferation are thought to be pivotal events that hasten the demise of synapses and neurons in AD. Fortunately, increased understanding of immune and inflammatory pathology in AD has provided new opportunities for designing disease-altering treatments for AD. Studies suggest that medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and immunomodulatory agents may have an important role in altering the course of AD. CY is a potent anti-inflammatory and immunomodulatory drug that inhibits proliferation of immune cells. This study will evaluate the effects of CY on individuals with mild to moderate AD. Participants in this study will be randomly assigned to receive either two different doses of CY or placebo (an inactive pill) for 6 months. Participants who receive placebo during the 6 months will have the option of receiving CY for an additional 6 months. Participants will undergo magnetic resonance imaging (MRI) scans of the brain. Measures of cerebral spinal fluid biomarkers or neurodegeneration, neuroinflammation, and neuroimmune activation will be taken. In addition, peripheral lymphocyte subsets and peripheral markers of inflammation will be assessed.
NCT00026819 Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain. Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal. Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.
NCT00031863 Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer Completed Cancer Research Campaign Clinical Trials Centre Phase 3 RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective in treating colorectal cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer.
NCT00038389 Study of Vioxx and Radiation Therapy for Brainstem Glioma Terminated M.D. Anderson Cancer Center Phase 1 It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma.
NCT00050362 Rofecoxib and Bupivacaine to Prevent Pain After Third Molar (Wisdom Tooth) Extraction Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 This study will evaluate the ability of the drugs rofecoxib and bupivacaine to prevent pain following third molar (wisdom tooth) extraction. Rofecoxib is approved to treat pain of arthritis and menstrual cramps. Bupivacaine is a local anesthetic similar to lidocaine, but longer acting. Healthy normal volunteers between 16 and 35 years of age who are in general good health and require extraction of their two lower wisdom teeth may be eligible for this study. Participants will have their two lower wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind one of the extraction sites. Ninety minutes before surgery, patients will take a dose of either rofecoxib, or a placebo (a pill with no active ingredient) by mouth. Just before surgery, they will receive an injection of either lidocaine or bupivacaine to numb the mouth and a sedative called midazolam (Versed® (Registered Trademark)) through an arm vein to cause drowsiness. After surgery, a small piece of tubing will be placed into one of the two extraction sites. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will remain in the clinic for up to 4 hours after surgery to monitor pain and drug side effects while the anesthetic wears off. During this time, they will complete pain questionnaires every 20 minutes. (Patients whose pain is unrelieved an hour after surgery may request and receive acetaminophen (Tylenol) and codeine.) The tubing then will be removed and they will be discharged with pain medicines (Tylenol, codeine and the study drug) and forms to record pain ratings. They will be given detailed instructions on how and when to take the medicines and how to record information in the pain diary. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic (lidocaine).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Rofecoxib

Condition Name

Condition Name for Rofecoxib
Intervention Trials
Postoperative Pain 5
Osteoarthritis 5
Pain 4
Prostate Cancer 2
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Condition MeSH

Condition MeSH for Rofecoxib
Intervention Trials
Osteoarthritis 8
Pain, Postoperative 8
Toothache 4
Colorectal Neoplasms 2
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Clinical Trial Locations for Rofecoxib

Trials by Country

Trials by Country for Rofecoxib
Location Trials
United States 31
Italy 14
Brazil 8
Israel 2
Canada 2
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Trials by US State

Trials by US State for Rofecoxib
Location Trials
Maryland 3
Pennsylvania 2
New Jersey 2
Texas 2
Arizona 1
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Clinical Trial Progress for Rofecoxib

Clinical Trial Phase

Clinical Trial Phase for Rofecoxib
Clinical Trial Phase Trials
Phase 4 12
Phase 3 14
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Rofecoxib
Clinical Trial Phase Trials
Completed 28
Terminated 8
Unknown status 2
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Clinical Trial Sponsors for Rofecoxib

Sponsor Name

Sponsor Name for Rofecoxib
Sponsor Trials
Merck Sharp & Dohme Corp. 18
National Institute of Dental and Craniofacial Research (NIDCR) 2
Johnson & Johnson Consumer and Personal Products Worldwide 2
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Sponsor Type

Sponsor Type for Rofecoxib
Sponsor Trials
Industry 24
Other 16
NIH 5
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