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7581. Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

terms Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Etoricoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cyclooxygenase 2 Inhibitors (...) Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale). Secondary Outcome Measures : The study drug will be safe and well tolerated during the course of the study. Eligibility Criteria Go to Information from the National Library of Medicine Choosing

2007 Clinical Trials

7582. The Effects of Aspirin and Acetaminophen on the Stomach in Healthy Volunteers

-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics (...) lining when compared to either medication alone. Condition or disease Intervention/treatment Phase Healthy Drug: Acetaminophen - 4 grams per day + Placebo Drug: Aspirin - 325 mg per day + Placebo Drug: Acetaminophen 4 gram per day + Aspirin 325 mg per day Phase 4 Detailed Description: Low dose aspirin is used for the primary and secondary prevention of cardiovascular thromboembolic events. As a non-selective inhibitor of cyclooxygenase, aspirin use results in irreversible COX-1 inhibition leading

2008 Clinical Trials

7583. Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

, 2010 Last Verified: August 2010 Keywords provided by POZEN: NSAID Gastric Ulcer High risk Arthrotec Vimovo Additional relevant MeSH terms: Layout table for MeSH terms Ulcer Stomach Ulcer Pathologic Processes Peptic Ulcer Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Misoprostol Esomeprazole Diclofenac Naproxen Arthrotec Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti (...) -Ulcer Agents Gastrointestinal Agents Oxytocics Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents

2007 Clinical Trials

7584. Sleep in Osteoarthritis Project

than or equal to 1 Experiences knee pain more than 5 days per week for more than 6 months Reports at least typical arthritic pain (a score of at least 2 out of 10, with 0 being no pain and 10 being the most extreme pain imaginable) Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen must be on a stable dose for at least 1 month prior to study entry Not scheduled for arthroplasty or surgery during projected period of study participation For participants with insomnia (...) levels for 2 weeks, will also be given to all participants. Optional Ancillary Sleep and Immunoreactivity Study Procedures Subjects who pass the visit one screen will be provided the option of participating in ancillary study procedures designed to assess inflammatory biomarkers present in plasma, physical functioning capabilities, and pain and mood status during the pain testing procedures. Subjects will be asked to give blood samples during the pain testing procedures, followed by standardized

2007 Clinical Trials

7585. Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

is getting mycophenolate and who is getting placebo) until 24 patients have completed the first three months of the protocol. Condition or disease Intervention/treatment Phase Systemic Lupus Erythematosus Arthritis Drug: mycophenolate mofetil Other: placebo Drug: Mycophenolate mofetil Not Applicable Detailed Description: Patients and Methods: 27 patients with active BILAG B or A arthritis, with at least 6 swollen and 6 tender joints entered a six month study of MMF vs placebo for three months followed (...) Endpoint: Partial response: One letter drop in musculoskeletal by Week 12 OR decrease to 0.5 or less tender + swollen jt counts Exploratory Measure (not prespecified): Major Clinical Response: BILAG C in musculoskeletal by Week 12 and decrease to 0.5 or less of tender +swollen jt counts. (In the primary analysis the one patient who met this endpoint was designated as a partial responder since those prespecified criteria were also met. Non response: Does not meet above criteria for complete or partial

2008 Clinical Trials

7586. Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Prednisone Minocycline Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory (...) of Nebraska Information provided by (Responsible Party): James R. O'Dell, MD, University of Nebraska Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early Rheumatoid Arthritis Condition or disease Intervention/treatment Phase Rheumatoid Arthritis Drug: Combination of Minocycline and MTX or MTX alone Drug: methotrexate Phase 3 Detailed Description: The purpose

2007 Clinical Trials

7587. Effects of Fish Oils on Inflammation and Insulin Resistance

/treatment Phase Metabolic Syndrome Insulin Resistance Drug: omega-3 fatty acid Drug: placebo Not Applicable Detailed Description: The development of type 2 diabetes (T2DM) represents a complex series of events, involving abnormalities in adipose tissue lipid distribution and insulin action. Along with an increase in adipose tissue mass is an increase in inflammation brought about by macrophages that infiltrate adipose tissue. These macrophages express inflammatory cytokines such as tumor necrosis factor (...) (TNF) and Interleukin -6 (IL-6) which are correlated with insulin resistance and metabolic syndrome, and suggest that metabolic syndrome and diabetes are conditions characterized by a state of chronic, low-grade inflammation. Thiazolidinediones (TZDs) improve insulin sensitivity via activation of peroxisome proliferator-activated receptor (PPAR) , and there is much evidence that PPAR agonists also have anti-inflammatory properties. Fish oils are rich sources of Omega-3 fatty acids

2007 Clinical Trials

7588. Does Aspirin Have a Protective Role Against Chemotherapeutically Induced Ototoxicity?

Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cisplatin Aspirin Antineoplastic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action (...) Chemotherapeutically Induced Ototoxicity? Study Start Date : February 2008 Estimated Study Completion Date : February 2010 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Placebo Comparator: 2 placebo OD during course of chemotherapy Drug: placebo OD for course of cisplatin chemotherapy Experimental: 1 325mg ASA OD during course of chemotherapy Drug: aspirin 325mg ASA OD for the duration

2007 Clinical Trials

7589. Study of Breast Cancer Prevention by Letrozole in High Risk Women

in High Risk Women Study Start Date : October 2006 Actual Primary Completion Date : March 2015 Actual Study Completion Date : March 2015 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Letrozole Letrozole, 2.5 mg daily for 6 months Drug: Letrozole Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months. Other Name: Letrozole(Femara) Placebo (...) of hyperplasia with atypia or borderline atypia, and a minimum Ki-67 of >1.5%. The primary hypothesis is that proliferation and expression of other estrogen response genes will be favorably modulated by six months of letrozole relative to placebo without substantially increasing hot flashes or worsening overall quality of life. Condition or disease Intervention/treatment Phase Breast Cancer Drug: Letrozole Drug: Placebo Phase 2 Detailed Description: Subsequent to the 6 month RPFNA for assessment

2007 Clinical Trials

7590. Effect of Genistein in Women With Metabolic Syndrome

, androgens, selective estrogen receptor modulators, or other steroids; treatment in the preceding six months with polyunsaturated n-3 fatty acids supplements, non steroidal anti-inflammatory drugs (NSAIDs) or steroids, that would interfere with evaluation of the study medication; smoking habit of more than 2 cigarettes daily. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using (...) of Drugs Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

2007 Clinical Trials

7591. Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

ClinicalTrials.gov Identifier: Other Study ID Numbers: HCT3012-X-303 First Posted: October 10, 2007 Last Update Posted: February 20, 2009 Last Verified: February 2009 Keywords provided by NicOx: Osteoarthritis Osteoarthritis, Hip Additional relevant MeSH terms: Layout table for MeSH terms Osteoarthritis Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Naproxen Naproxen-n-butyl nitrate Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory (...) System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nitric Oxide Donors

2007 Clinical Trials

7592. G-CSF in Preventing Neutropenia During First-Line Treatment With Chemotherapy and Bevacizumab in Patients With Metastatic Colorectal Cancer

works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer. Condition or disease Intervention/treatment Phase Colorectal Cancer Biological: bevacizumab Biological: filgrastim Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 2 Detailed Description: OBJECTIVES: Primary Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to obtain neutropenia lower than grade 4 (...) *28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1 Study Start Date : November 2007 Actual Primary Completion Date : September 2013 Actual Study Completion Date : December 2013 Resource links provided by the National Library of Medicine related topics: related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire Biological

2007 Clinical Trials

7593. Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situations Known hypersensitivity to any component of bevacizumab PRIOR CONCURRENT THERAPY: More than 7 days since prior radiotherapy and recovered No concurrent full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular-weight heparin) More than 10 days since prior and no concurrent aspirin ≥ 325 mg/day or chronic use of nonsteroidal anti-inflammatory drugs More than 28 days since prior (...) or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer

2007 Clinical Trials

7594. Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by Surgery

: Completed First Posted : October 8, 2007 Last Update Posted : May 17, 2011 Sponsor: Centre Oscar Lambret Information provided by: National Cancer Institute (NCI) Study Details Study Description Go to Brief Summary: RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving (...) pemetrexed together with cisplatin and vitamin B12 may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving pemetrexed together with cisplatin and vitamin B12 works in treating patients with mesothelioma of the chest that cannot be removed by surgery. Condition or disease Intervention/treatment Phase Malignant Mesothelioma Dietary Supplement: vitamin B12 Drug: cisplatin Drug: pemetrexed disodium Genetic: gene expression analysis Other: laboratory biomarker analysis

2007 Clinical Trials

7595. Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP)

treated with investigational products within last one month." At Randomization (Week 0) Subject wishes to withdraw consent. Subject is lost to follow-up. Subject has consumed anti-platelet agents (e.g., ticlopidine and aspirin), anticoagulants, or non-steroidal anti-inflammatory drugs (NSAIDs) for 7days prior to the first dose of study medication and will require these medications during the study period. Subjects who are deemed unsuitable for the study by the investigator (or sub investigator (...) in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety. Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline [ Time Frame: Baseline through Week 26 ] ITP medications are drugs, such as steroids or immunoglobulin, to be used for ITP. Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label

2007 Clinical Trials

7596. Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients

by temperature greater than or equal to 38.0 degree celsius (100.4 degree fahrenheit) Exclusion Criteria: Patients with electric burns Use of acetaminophen, non-steriodal anti-inflammatory agents (NSAIDs) or other fever reducing medications within 4 hours prior to dosing Patients taking warfarin or lithium Active, clinically significant asthma History of allergy or hypersensitivity to any component of intravenous ibuprofen, NSAIDs, aspirin (or related products), or COX-2 inhibitors Pregnant or nursing (...) Manager, Regulatory Affairs, Cumberland Pharmaceuticals Inc. ClinicalTrials.gov Identifier: Other Study ID Numbers: CPI-CL-010 First Posted: February 4, 2008 Results First Posted: August 11, 2011 Last Update Posted: August 11, 2011 Last Verified: July 2011 Additional relevant MeSH terms: Layout table for MeSH terms Burns Wounds and Injuries Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects

2008 Clinical Trials

7597. Study of Atacicept in Anti-TNFα-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

approved or investigational biological compound for RA, including but not restricted to any anti-TNFalpha agents, rituximab, abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab Treatment with disease-modifying anti-rheumatic drug (DMARDs) other than MTX Participation in any interventional clinical trial within 1 month before study Day 1 MTX dose >25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid or non-steroidal anti-inflammatory drug (NSAID (...) to methotrexate (MTX) and no previous exposure to anti-tumor necrosis factor alpha (anti-TNFalpha) therapy. Condition or disease Intervention/treatment Phase Rheumatoid Arthritis Drug: Placebo matched to atacicept Drug: Atacicept: with loading dose Drug: Atacicept Biological: Adalimumab Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 311 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double

2008 Clinical Trials

7598. Bevacizumab in the Radiation Treatment of Recurrent Malignant Glioma

. Bevacizumab is an experimental drug that blocks a molecule called VEGF that is found in high amounts in malignant gliomas. VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, Bevacizumab slowed the growth of several different types of human cancer cells by blocking the effects of VEGF. There is also evidence that Bevacizumab enhances the effects of radiation on tumor cell Condition or disease Intervention/treatment Phase Brain Cancer Recurrent (...) : May 2017 Actual Study Completion Date : May 2017 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Arm Intervention/treatment Experimental: 1 bevacizumab and radiation (IMRT) Other: bevacizumab and radiation (IMRT) bevacizumab 10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (cycle defined as 28 days). If the tumor volume remains < 40 cc, the patient will undergo stereotactic radiotherapy with IMRT

2008 Clinical Trials

7599. Efficacy Study of an Anti-Tumor Necrosis Factor (TNF) Alpha Agent in Patients With Hand Osteoarthritis

inflammatory features are particularly refractory to usual treatments (analgesics, NSAIDs, braces and local injections). The mechanism of osteoarthritis involves two major cytokines: interleukin-1 beta and tumor necrosis factor alpha. TNF alpha is particularly involved in the inflammation process. The aim of the present study is to study the efficacy of TNF alpha blockers (2 injections of adalimumab compared to placebo injections in patients with severe and refractory hand osteoarthritis. We hope (...) that such new therapeutic option may induce substantial pain relief. Condition or disease Intervention/treatment Phase Hand Osteoarthritis Other: Adalimumab (Humira®) Other: Placebo Phase 3 Detailed Description: Objective: To demonstrate the efficacy of two subcutaneous injections of anti-TNF alpha (adalimumab) in patients with DO refractory to usual treatments (NSAIDs - analgesics). Design: Randomized placebo-controlled multicenter (20 sites (amendment 18/12/2008)) trial Trial duration: 6 months follow-up

2008 Clinical Trials

7600. Efficacy of Celecoxib 200mg in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee

Posted: January 18, 2008 Last Update Posted: January 18, 2008 Last Verified: December 2007 Keywords provided by University Hospitals Cleveland Medical Center: Osteoarthritis Knee pain Additional relevant MeSH terms: Layout table for MeSH terms Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological (...) for therapy with an anti-inflammatory analgesic. If on an NSAID or analgesic, patient must have completed a washout period prior to baseline assessments that is a minium of five half lives. The patient has provided written informed consent before undergoing any study procedures. Exclusion Criteria: Diagnosed as having inflammatory arthritis or acute trauma at the index joint. Another painful condition that would interfere with his/her ability to walk or to make reasonable assessments of their pain

2008 Clinical Trials

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