A Multicentric, open label, non - comparative, prospective evaluation of misuse potential (if any), of Proxyvon (Combination of â?? Propoxyphene Napsylate and Acetaminophen) in Indian patients with mild to moderate pain.

Wockhardt Limited0 个研究点目标入组 900 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patient of either sex aged between 18 to 65 years (inclusive)
•Patients clinically diagnosed with mild to moderate pain (pain score greater than or equal to 7) not responding to Acetaminophen or NSAID monotherapy.
•Patients having the willingness and ability to understand and provide informed consent to participate in the study and are able to communicate with the investigator and follow all directions.
•Patients willing to undertake the contraceptive measures to prevent pregnancy during the study period.

•Patients with known hypersensitivity to Propoxyphene napsylate or Acetaminophen
•Patients suffering from any disorder of kidney, liver or any unstable, clinically significant, or life-threatening medical disorders or any other underlying serious medical condition.
•Patients with history of glaucoma, urinary retention, alcohol or drug abuse or SOAPP score > 7. (Refer section 10.0)
•Patients currently taking tranquilizers or anti depressant drugs, sedatives, hypnotics or alcohol in excess.
•Patients with h/o psychiatric / psychological disorders or suicidal ideation.
•Patients with renal or hepatic failure.
•Pregnant or lactating women.
•Patients with any serious clinical conditions that according to the investigator may interfere with the evaluation

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