Randomised, Double Dummy, Placebo Controlled, Multicentre, Parallel-Group, Single Dose Study to Compare the Analgesic Efficacy and Safety of IBALGIN Extra Fast /ibuprofen lysin/ to conventional Ibuprofen in the Treatment of Acute Pain

INTERVENTION:

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 Concentration number: 684‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Nurofen Forte Product Name: Nurofen Forte Pharmaceutical Form: Coated tablet INN or Proposed

INN:

ibuprofen CAS Number: 15687‐27‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

CONDITION:

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

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

PRIMARY OUTCOME:

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.; 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.; 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 ;