Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01216163 | Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain | PHASE3 | COMPLETED | 218 | — | — | Oct 1, 2010 | Jan 1, 2011 | Aug 20, 2012 | 1 | United States |
| NCT01098747 | Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain | PHASE3 | COMPLETED | 335 | — | — | Apr 1, 2010 | Aug 1, 2010 | Aug 17, 2012 | - | — |
| NCT01077973 | Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache | PHASE3 | COMPLETED | 200 | — | — | Mar 1, 2010 | Oct 1, 2010 | Aug 20, 2012 | - | — |
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | - |
| Treatment B | ACTIVE_COMPARATOR | - |
| Treatment C | PLACEBO_COMPARATOR | - |
| Treatment D | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Novel Ibuprofen | DRUG | Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) |
| Acetaminophen | DRUG | Single-dose of acetaminophen (1000mg) |
| Placebo | DRUG | Single-dose of placebo |
| Standard Ibuprofen | DRUG | Single-dose of standard ibuprofen (400mg) |
Inclusion Criteria: * Normal, healthy males and females 16 to 40 years of age * Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating \[VAS-PSR\] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more ...