A prospective, randomized, open-label, two-arm, active-controlled, parallel, multicentre, post marketing clinical trial to assess the efficacy and safety of FDC of Diclofenac (50 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) as compared to FDC of Aceclofenac (100 mg) plus Paracetamol (325 mg) plus Serratiopeptidase (15 mg) in patients with postoperative dental pain after third molar surgery

Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•1. Male and Female patients of age 18-45 years (both inclusive).
•2. Patients needing extraction for impacted third molars under local anaesthesia.
•3. Patients having moderate to severe pain at baseline (once surgery is over and local anaesthetic effect has subsided).
•4. Patients in general good health- American Society of Anaesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of outpatient conscious sedation).
•5. Patients willing to give written informed consent and comply with the study procedure

•1. Patients with known hypersensitivity to any of the study drugs.
•2. Patients with any contraindication to the study drugs.
•3. Patients who are pregnant or nursing.
•4. Patients with history of peptic ulcers and/or GI bleeding.
•5. Patients with unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery).
•6. Patients developing any complication during or after surgery. Unusual surgical difficulty.
•7. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy. 8. Patients with continuing history of alcohol and/or drug abuse. 9. Participation in another clinical trial in the past 1 month prior to screening. 10. Any other reason for which the investigator feels that patient should not participate.

发起方

Alkem Laboratories Limited