subject is indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone MedDRA version: 9.1 Level: LLT Classification code 10028819 Term: Nausea vomiting and diarrhea MedDRA version: 9.1 Level: LLT Classification code 10019211 Term: Headache MedDRA version: 9.1 Level: LLT Classification code 10017822 Term: Gastric ulcer
Conditions
Interventions
Product Name: Ibalgin Extra Fast
Pharmaceutical Form: Coated tablet
CAS Number: 57469-77-9
Other descriptive name: ibuprofen lysinate
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Zentiva a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent obtained • Subject is indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone • Subjects between 18 – 60 years, both sexes • Negative pregnancy test in females with childbearing potential • Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment, anti-inflammatory drugs, sedative-hypnotics, or antidepressants, tranquilizers, alcohol or caffeine-containing beverages up to 6 hrs post dose • Ability to read, comprehend, and record information required by protocol. 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Acute purulent infammation in the area of the planned bony-impacted 3rd molar removal • Another acute or chronic painful physical condition • Use of any analgesics, anti-inflammatory drugs, sedative-hypnotics, or antidepressants, tranquilizers, alcohol or caffeine-containing beverages from midnigt of the night prior to surgery • Subject has a history or presence of significant organ disease • Active gastric or duodenal ulcer • Clotting and a haematogenesis disorders • Any other disease or condition which may interfere with study assessments as judged by the investigator • Subjects taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months • Subjects with history of hypersensitivity to the study drug or its excipients • Subjects likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator • Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess Superiority of Nurofen forte® (the active comparator) over placebo in TOTPAR (to demonstrate assay sensitivity), Global Assessment of Medication , Remedication time, Time to pain half gone, Time to any pain relief, Time to meaningful pain relief, Sum of Pain Intensity Difference (SPID), Safety ;Main Objective: To demonstrate that: 1. Ibalgin Extra Fast® is superior over placebo in overall analgesic efficacy. This conclusion will be drawn if and only if the lower limit of the two-sided 95% confidence interval for the treatment difference (test-placebo) in TOTPAR is greater than zero. 2. Ibalgin Extra Fast® is non-inferior to Nurofen forte® (the active comparator) in overall analgesic efficacy. This conclusion will be drawn if and only if 1. is concluded and two-sided 95% confidence interval for the treatment difference (test-active comparator) in TOTPAR lies entirely to the right of the non-inferiority margin. 3. Ibalgin Extra Fast® is superior over Nurofen forte® (the active comparator) in the onset of action. This conclusion will be drawn if and only if 2. is concluded and the lower limit of the two-sided 95% confidence interval for the treatment difference (test-active comparator) in PAR45 is greater than zero. ;Primary end point(s): To demonstrate that: 1. Ibalgin Extra Fast® is superior over placebo in overall analgesic efficacy. This conclusion will be drawn if and only if the lower limit of the two-sided 95% confidence interval for the treatment difference (test-placebo) in TOTPAR is greater than zero. 2. Ibalgin Extra Fast® is non-inferior to Nurofen forte® (the active comparator) in overall analgesic efficacy. This conclusion will be drawn if and only if 1. is concluded and two-sided 95% confidence interval for the treatment difference (test-active comparator) in TOTPAR lies entirely to the right of the non-inferiority margin. 3. Ibalgin Extra Fast® is superior over Nurofen forte® (the active comparator) in the onset of action | — |
Countries
Czech Republic
Outcome results
None listed