CTRI/2023/11/060049进行中（未招募）3 期
A Prospective, Multicentric, Double blind, Randomized, Active Controlled, ParallelStudy to Evaluate the Efficacy and Safety of Fixed Dose Combination of Polmacoxib2mg and Paracetamol 325mg compared to Fixed Dose Combination of Etoricoxib 60mgand Paracetamol 325mg in Adults with Acute Pain due to Dental Extraction - Nil
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult male or female subjects aged of 18-65 years.
- •2. Subjects willing to give written, signed, and dated informed consent to participate
- •in the study.
- •3. Subjects requiring dental extraction other than 3rd molar.
- •4. Patients who agree not to use any other approved or experimental
- •pharmacological treatments for their pain, other than mentioned in the protocol,
- •at any time during the study.
- •5. Females of childbearing potential who are sexually active must agree to use
- •barrier contraception and can neither be pregnant nor lactating from screening
- •throughout the duration of the study.
- •6. Clinical laboratory evaluations (including clinical chemistry, hematology, and
- •complete urinalysis) within the reference range for the testing laboratory or the
- •results are deemed not clinically significant for inclusion into this study by the
- •investigator.
排除标准
- •1. Patients with any contraindication, hypersensitivity or intolerance to either
- •paracetamol or polmacoxib or with history of hypersensitivity reactions to drugs
- •of similar chemical classes or to any of its excipients
- •2. History of Hepatitis B, Hepatitis C or HIV infection.
- •3. Patients on anticonvulsants, antidepressants (e.g., tricyclic, tetracyclic, atypical),
- •aspirin at doses >81 mg/day, benzodiazepines, opioids, herbal medications,
- •mexiletine HCl.
- •4. Patients using the following medications:
- •a. Use of anticoagulants within 2 weeks of screening
- •b. Use of analgesics within 48 hours before screening (except
- •acetaminophen 650 mg/ day as rescue medication)
- •c. Use of steroids within 6 weeks or currently on steroids.
- •5. Concurrent use of corticosteroids, herbal medicines, traditional medicines,
- •nutraceuticals, glucosamine, and/or chondroitin sulfate.
- •6. Patients with HbAlc greater than 8% at screening
- •7. Patients with history of epilepsy or seizure disorder requiring treatment with antiepileptic
- •8. Patients with known alcohol or other substance abuse within last one year.
- •9. Patients with history of cardiovascular disease (uncontrolled hypertension i.e.
- •=140/90 mm of Hg, congestive heart failure, ischemic.
- •10. If serum NT-pro-BNP level is greater than 125 pg/mL.
- •11. Subjects with history of rheumatic fever.
- •12. Subjects with history of blood dyscrasia (i.e. hemophilia or platelet disorders.
- •13. Subjects with acute pericoronal abscess or pericoronitis or Ludwig’s angina.
- •14. Subjects with history of heavy irradiation for dental lesions.
- •15. Dental extraction site is in proximity to an area of infection or malignancy.
- •16. Subjects with history of malignant disorders like leukemia and lymphoma.
- •17. Medical condition or disorder that would interfere with the ADME of study drugs.
研究者
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