A Prospective, Multicentric, Double blind, Randomized, Active Controlled, Parallel Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Polmacoxib 2mg and Paracetamol 325mg compared to Fixed Dose Combination of Etoricoxib 60mg and Paracetamol 325mg in Adults with Acute Pain due to Dental Extraction
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Hetero Labs Limited
- Enrollment
- 160
- Locations
- 5
- Primary Endpoint
- Percent change in mean pain intensity decrease measured by Numeric Pain Rating
Study Overview
Brief Summary
This prospective, multicentric, double blind, randomized, active controlled, parallel study designed to evaluate the efficacy and safety of FDC of polmacoxib 2mg and paracetamol 325mg (test- drug) compared to FDC of etoricoxib 60mg and paracetamol 325mg (reference drug) in adults with acute pain due to dental extraction.
Adult male and female subjects (18 – 65 years), across the country among 10-12 geographically distributed study sites, with acute pain due to dental extraction would be recruited, who meet all the inclusion criteria and none of the exclusion criteria, to assess the pain intensity with Numeric Pain Rating Scale (NPRS). Since the study is designed to carry in 1:1 ratio of test versus reference treatments, 144 patients (72 per arm) would be sufficient to prove non-inferiority of test drug compared to reference drug at one sided 2.5% level of significance, 80% power and -20% of noninferiority margin. The demographic and baseline characteristics will be assessed before initiating the study.
Percent change in mean pain intensity decrease measured by NPR scale from start of medication to 48 hours, percent change in mean pain intensity decrease measured by NPR scale from start of medication to 6 hours and 24 hours are the primary and secondary study endpoints respectively.
Change in mean pain intensity decrease, mean sum of pain intensity difference over 0 to 6, 0 to 24 and 0 to 48 hours (NPRS SPID-6, NPRS SPID-24, NPRS SPID-48), change in mean pain relief score on a 5-point scale at 6 hours, 24 hours and 48 hours, total pain relief (TOTPAR) over 0 to 6, 0 to 24 and 0 to 48 hours (TOTPAR-6, TOTPAR-24, TOTPAR-48), proportion of subjects used rescue medication during the study period, patient’s global impression of improvement (PGI-I) at 6 hours, 24 hours and 48 hours are the different treatment outcome measures at respective time points.
Treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse drug reactions (ADRs), clinical & laboratory parameters, vital signs, and electrocardiogram (ECG) data in 8 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult male or female subjects aged of 18-65 years.
- •Subjects willing to give written, signed, and dated informed consent to participate in the study.
- •Subjects requiring dental extraction other than 3rd molar.
- •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.
- •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.
- •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
- •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
- •History of Hepatitis B, Hepatitis C or HIV infection.
- •Patients on anticonvulsants, antidepressants (e.g., tricyclic, tetracyclic, atypical), aspirin at doses >81 mg/day, benzodiazepines, opioids, herbal medications, mexiletine HCl.
- •Patients using the following medications: a.
- •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.
- •Concurrent use of corticosteroids, herbal medicines, traditional medicines, nutraceuticals, glucosamine, and/or chondroitin sulfate.
- •Patients with HbAlc greater than 8% at screening
- •Patients with history of epilepsy or seizure disorder requiring treatment with antiepileptic drugs.
- •Patients with known alcohol or other substance abuse within last one year.
- •Patients with history of cardiovascular disease (uncontrolled hypertension i.e. ≥140/90 mm of Hg, congestive heart failure, ischemic.
- •If serum NT-pro-BNP level is greater than 125 pg/mL.
- •Subjects with history of rheumatic fever.
- •Subjects with history of blood dyscrasia (i.e. hemophilia or platelet disorders.
- •Subjects with acute pericoronal abscess or pericoronitis or Ludwig’s angina.
- •Subjects with history of heavy irradiation for dental lesions.
- •Subjects with history of malignant disorders like leukemia and lymphoma.
- •Medical condition or disorder that would interfere with the ADME of study drugs.
Outcomes
Primary Outcomes
Percent change in mean pain intensity decrease measured by Numeric Pain Rating
Time Frame: 48 hours
Scale from start of medication to 48 hours
Time Frame: 48 hours
Secondary Outcomes
- Percent change in mean pain intensity decrease measured by Numeric Pain Rating(Scale)
- Change in mean pain intensity decrease measured by Numeric Pain Rating Scale(Baseline to 6 hours, 24 hours and 48 hours)
- Mean Sum of Pain Intensity Difference (SPID)((NPRS SPID-6, NPRS SPID-24, NPRS SPID-48))
- Change in mean pain relief score on a 5-point scale(6 hours, 24 hours and 48 hours)
- Total pain relief (TOTPAR-6,(TOTPAR-24, TOTPAR-48))
- Proportion of subjects used rescue medication during the study period(48 hours)
- Patient’s Global Impression of Improvement (PGI-I)(6 hours, 24 hours and 48 hours)
- Treatment emergent clinical & laboratory adverse events (TEAEs).(48 hours)
Investigators
Dr Shubhadeep Sinha MD
Hetero Group