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Efficacy and safety studies Overview of pivotal studies The efficacy and tolerability of tapentadol SR were investigated in four Phase II double-blind, placebo and active-controlled tapentadol studies .
These were conducted to provide guidance for the development of nucynta er coupon nucynta withdrawal timeline tapentadol droge tapentadol glucuronide tapentadol the clinical Phase III trials .
AusPAR Palexia SR Tapentadol CSL Ltd PM-2009-02489-3-1 Final 28 February 2011 Page 27 of 126 In Phase III, two placebo- and active-controlled (oxycodone controlled-release (CR) formulation) studies were conducted to assess the efficacy of tapentadol SR in the relief of moderate to tapentadol severe pain in subjects with chronic pain due to osteoarthritis of the knee (PAI-3008/KF11 and PAI3009/KF12) .
One placebo and active- controlled (oxycodone CR) study was conducted to assess the efficacy of tapentadol SR in the relief of moderate to severe pain in subjects with chronic low tapentadol dolor neuropatico nucynta compared to oxycodone tapentadol dea schedule tapentadol for back pain (PAI-3011/KF23) .
Studies KF5503/11, KF5503/12 and KF5503/23 were nominated tapentadol as the pivotal studies .
They are summarised in Table 4 below) There was a further placebo-controlled efficacy study in subjects with painful tapentadol diabetic peripheral neuropathy (PAI-3015/KF36) .
A randomized one year safety study (PAI-3007/KF24) with two treatment groups (tapentadol SR and tapentadol with paracetamol tapentadol gastrointestinal nucynta rash tapentadol receptors tapentadol oxycodone CR) was performed which supplied comparative long-term safety in addition to data on maintenance of efficacy .

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