drugset / Trial / NCT02811991

A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia

NCT02811991

Phase 2/3 Completed 348 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal analgesia. This medication is generally safe, well tolerated and effective within recommended daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.

Timeline

Start
2016-06
Primary completion
2018-09-14
Completion
2019-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 325 mg Intravenous
Comparator Acetaminophen Small molecule 500 mg Intravenous
Comparator Morphine Other / unclassified 0.25 mg

Indications

No indication recorded.