Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nurofen Plus · 1 trial · 1 indication
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
| Arm | Type | Description |
|---|---|---|
| Ibuprofen/acetaminophen (lower dose) | EXPERIMENTAL | One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet |
| Ibuprofen/acetaminophen (higher dose) | EXPERIMENTAL | Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg |
| Nurofen Plus® | ACTIVE_COMPARATOR | Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) |
| Panadeine® Extra | ACTIVE_COMPARATOR | Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) |
| Placebo | PLACEBO_COMPARATOR | Two placebo tablets |
| Name | Type | Description |
|---|---|---|
| Ibuprofen/acetaminophen | DRUG | One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water |
| Ibuprofen/acetaminophen (higher dose) | DRUG | Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water |
| Nurofen Plus® | DRUG | Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water |
| Panadeine® Extra | DRUG | Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water |
| Placebo | DRUG | Two placebo tablets, single dose taken orally with 300 ml water |
Main Inclusion Criteria: Experiencing moderate to severe pain after extraction of impacted third molars Main Exclusion Criteria: Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any cond...