Polmacoxib and Paracetamol combination effectiveness in pain relief after dental extractio
- Conditions
- Health Condition 1: G978- Other intraoperative and postprocedural complications and disorders of nervous system
- Registration Number
- CTRI/2023/11/060049
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in mean pain intensity decrease measured by Numeric Pain Rating <br/ ><br>Scale from start of medication to 48 hoursTimepoint: 48 hours
- Secondary Outcome Measures
Name Time Method 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) <br/ ><br>(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 <br/ ><br>ScaleTimepoint: Baseline, 6, 24, 48 hours;Proportion of subjects used rescue medication during the study periodTimepoint: 48 hours;Total pain relief (TOTPAR-6, <br/ ><br>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