Tapentadol

Clinical Trials Listing

Trial ID Title Indication
KF5503/45

An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with severe chronic nociceptive, mixed or neuropathic low back pain taking WHO Step III analgesics but showing a lack of tolerability

Chronic nociceptive, mixed or neuropathic low back pain
Trial ID Title Indication
KF5503-73

Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of intravenous tapentadol solution for injection for the treatment of post-surgical pain in children aged from birth to less than 2 years, including preterm neonates

Moderate to severe acute post-operative pain
Trial ID Title Indication
KF5503/37

A randomized, double-blind, parallel-group, multi-center, active- and placebo-controlled trial to evaluate the analgesic efficacy and safety of multiple doses of CG5503 IR for postoperative pain following bunionectomy

Post-operative pain following bunionectomy
Trial ID Title Indication
KF5503/12

A randomized double-blind, placebo- and active-control, parallel-arm, Phase 3 study with controlled adjustment of dose to evaluate the efficacy and safety of tapentadol extended-release (ER) in subjects with moderate to severe chronic pain due to osteoarthritis of the knee

Chronic pain in subjects for whom an opioid treatment is clinically appropriate
Trial ID Title Indication
KF5503/52

Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol PR in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF5503/15 trial

Chronic malignant tumor-related pain

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