A randomized open label comparative study evaluating the efficacy and tolerability of diclofenac (50 mg) + paracetamol (500 mg) FDC vs. paracetamol 500 mg in the management of dental pain following tooth extraction

Troikaa Pharmaceuticals Limited0 个研究点目标入组 50 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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•1.Patients undergoing tooth extraction under local anesthesia.
•2.Between the ages of 16 to 35 years
•3.Willing to undergo observation period for four hours post-extraction
•4.Willing for telephonic follow up and at least 1 follow up visit.
•5.Ability to complete a 10 cm visual analog scale and a category scale every 30 minutes for the first 4 post extraction hours

•1.Surgical Time in excess of 45 minutes
•2.Patients with known hypersensitivity to any of the study drugs
•3.Patients with any contraindications to the study drugs
•4.Patients who are pregnant or nursing
•5.Patients with history of peptic ulcers and/or GI bleeding
•6.Patients who have significant psychiatric history
•7.Patients with severe kidney/ liver disease
•8.Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; warfarin or other anti- coagulants
•9.Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery)
•10.Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomisation;
•11. Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).

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