CLINICAL TRIALS PROFILE FOR DICLOFENAC POTASSIUM
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All Clinical Trials for Diclofenac Potassium
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00474136 ↗ | Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium | Completed | Javelin Pharmaceuticals | Phase 1 | 2007-03-01 | The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18.75 mg and 37.5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (Cataflam® 50 mg), the approved reference product. |
| NCT01009021 ↗ | Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy | Completed | University of Sao Paulo | N/A | 2008-03-01 | The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation. Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure. |
| NCT01019980 ↗ | Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections | Terminated | Novartis Pharmaceuticals | Phase 4 | 2010-03-01 | The purpose of this study is to assess if a single dose of Diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of Acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. This is a comparative double blind, double dummy, randomized study on the effectiveness of Diclofenac potassium versus Acetaminophen in febrile children with acute upper respiratory tract infections. The patient will be randomized to either group: Group A (Diclofenac potassium (0.5 mg/kg) or Group B (Acetaminophen (10 mg/kg)). A Health Care Professional trained will measure the temperature during 2 hours. During the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home. |
| NCT01257126 ↗ | Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection | Withdrawn | Novartis Pharmaceuticals | Phase 4 | 2011-04-01 | This is a local, phase IV, open-label, randomized, head to head study of children aged 3 to 7 years. The objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection. |
| NCT01458600 ↗ | Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study) | Completed | Mikael Lantz | Phase 4 | 2006-09-01 | AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months. |
| NCT01666197 ↗ | Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain | Completed | Novartis | Phase 4 | 2012-08-01 | The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief. |
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