Extrait

Background and study aims The products being tested in this study, i.e. Akis, Voltaren and Voltarol, contain the active ingredient diclofenac sodium which is a NSAID (non-steroidal anti-inflammatory drug). NSAIDs are known to work well in alleviating acute (short term) pain, including renal colic (caused by kidney stones), osteo and rheumatoid arthritis, back pain, gout, trauma and fractures, and pain that can be experienced after surgery. Akis 25/50/75 mg/1 mL (diclofenac sodium) solution for injection is approved for both intramuscular (i.m.) (injection given into a muscle) or subcutaneous (s.c.) (injection given under the skin) administration. A new route of administration, i.e. intravenous (i.v.) (into the vein) bolus injection, has been investigated in this study. An intravenous bolus is a relatively large dose of a drug given intravenously and rapidly all at once rather than being given more gradually over a period of time. The aim of this study is to look at how safe this new route of administration is. Who can participate? Healthy adult volunteers, aged 18-55. What does the study involve? This study is split into four separate parts. For the first part, the volunteers are allocated to one of three groups. They are all then given one single dose (or bolus) of Akis diclofenac sodium (either 25mg/1 mL solution, 50mg/1 mL solution or 75mg/1 mL solution) and observed for effects over the next 11 days. For the second part, each volunteer is randomly allocated into one of 4 study groups. Each study group is then given all 4 of the following treatments, in a random order, with a “wash out” (break period) of at least 7 days between each treatment: either 75 mg/1 mL of Akis diclofenac sodium injected over a period of 5 seconds, 15 seconds or 30 seconds or a control i.m. treatment ( reference formulation) of Voltaren, diclofenac sodium (75 mg/3 mL solution). The third part involves randomly allocating each volunteer into one of 3 study groups and then given all 3 of the following treatments in a random order with a wash out period of at least 7 days between each treatment: either the test treatment, Akis, diclofenac sodium (75mg/1 mL) at the best performing injection rate selected after completion of part 2 of the study (above), or one of two reference (treatment as usual, or control treatments) of Voltarol, diclofenac sodium (75mg/3 mL), given either by a i.m. injection or a i.v. drip over 30 minutes. For the last part of the study, each volunteer is given one single dose of Akis, diclofenac sodium 75 mg/1 mL solution by injection at the rate determined in part 2. What are the possible benefits and risks of participating? There are no potential benefits to participating in this study. All the products being tested contain the widely used and well known active substance diclofenac sodium. The most common possible side effects include headache, dizziness, nausea, vomiting, diarrhoea, indigestion, abdominal pain, flatulence, anorexia, transaminase (liver enzyme) increases, rash and reactions at the injection site, including pain and swelling. Rarer side effects include hypersensitivity (allergic reaction), anaphylactic/anaphylactoid reactions (including low blood pressure and shock) , sleepiness, tiredness, asthma, gastritis, gastrointestinal haemorrhage, vomiting blood, bloody diarrhoea, melaena (dark, sticky faeces containing blood), gastrointestinal ulcer with or without bleeding or perforation, hepatitis, jaundice, liver disorder, hives and fluid retention (oedema). Reactions to the i.v. injections can occasionally occur. These include thrombophlebitis (vein swelling with blood clotting), raised body temperature, and discomfort or burning at the injection site. Where is the study run from? CROSS Research Phase I Unit, Arzo (Switzerland) When is the study starting and how long is it expected to run for? October 2014 to November 2015 Who is funding the study? IBSA Biochemical Institute SA (Switzerland) Who is the main contact? Dr Milko Radicioni

Critère d'inclusion

• Exposure (AUC) of diclofenac sodium in healthy adults

Liens

• ictrp
• isrctn