treatment of pain following third molar extraction Level: PT Classification code 10056350
Conditions
Interventions
Product Name: GRC6211
Product Code: GRC6211
Pharmaceutical Form: Oral powder
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo:
Sponsors
GLENMARK PHARMACEUTICALS SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients (18-50 years of age), previously scheduled for extraction of at least one 3rd impacted mandibular molar tooth under local anaesthesia, and who are otherwise healthy, will be recruited. -females of childbearing potential must be using adequate contraception. -Patient complaining of moderate to severe pain on Verbal Rating Scale (VRS) within 3 hours after the end of surgery. -Patient agreeing not to take analgesics other than protocol defined rescue analgesics during treatment period (up to 24 hrs post dose). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patient who has a history or presence of significant organ disease or mental illness. -Patient who has been exposed to analgesics within 24 hours prior to the start of surgery. -Patient who is unable to refrain from alcohol, psychoactive drugs, and sedatives (e.g. benzodiazepines) within 48 hours prior from the start of surgery and for 48hrs post dose. -Patient who is judged by the investigator not to be a suitable candidate for ibuprofen or co-efferalgan therapy based on medical history; -Patient has a history of drug or alcohol abuse. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males and intake greater than 14 units per week or an average daily intake of greater than two units for females. -History of sensitivity to any of the study medications, or components or a history of drug; -Has a supine systolic blood pressure which is outside the range of 90 to 140 mmHg, supine diastolic blood pressure is outside the range of 50 to 90 mmHg or supine heart rate is outside the range 45-100 bpm. -QTc interval ≥450ms,a family history of Long QT syndrome, the use of concomitant medications that prolong the QT/QTc interval.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the analgesic efficacy of GRC 6211 in patients experiencing moderate to severe pain following extraction of impacted mandibular third molar tooth;Secondary Objective: -To evaluate the safety and tolerability of GRC 6211 To evaluate the pharmacokinetic and pharmacodynamic relationship between GRC 6211 exposure and its analgesic effect. To compare the analgesic efficacy of GRC 6211 to the analgesic efficacy of ibuprofen.;Primary end point(s): PRIMARY EFFICACY: Sum of pain intensity differences (SPID) measured by VRS over 6 hr post dosing | — |
Countries
Italy
Outcome results
None listed