Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system
Conditions
Interventions
Intervention1: Polmacoxib 2mg and Paracetamol 325mg
tablets: One tablet once a day with food for 3
days
Control Intervention1: Etoricoxib 60mg and Paracetamol
325mg Tablets: One tablet once a day with
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 drugs. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in mean pain intensity decrease measured by Numeric Pain Rating Scale from start of medication to 48 hoursTimepoint: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean pain intensity decrease measured by Numeric Pain Rating ScaleTimepoint: Baseline to 6 hours, 24 hours and 48 hours;Change in mean pain relief score on a 5-point scaleTimepoint: 6 hours, 24 hours and 48 hours;Mean Sum of Pain Intensity Difference (SPID) (NPRS SPID-6, NPRS SPID-24, NPRS SPID-48)Timepoint: 0 to 6, 0 to 24 and 0 to 48 hours;Patient’s Global Impression of Improvement (PGI-I)Timepoint: 6 hours, 24 hours and 48 hours;Percent change in mean pain intensity decrease measured by Numeric Pain Rating ScaleTimepoint: Baseline, 6, 24, 48 hours;Proportion of subjects used rescue medication during the study periodTimepoint: 48 hours;Total pain relief (TOTPAR-6, TOTPAR-24, TOTPAR-48)Timepoint: 0 to 6, 0 to 24 and 0 to 48 hours;Treatment emergent clinical & laboratory adverse events (TEAEs).Timepoint: 48 hours | — |
Countries
India
Contacts
Public ContactDr Subhadeep Sinha MD
Hetero Labs Limited
Outcome results
None listed