A Phase 3 interventional study of FDC IBU/APAP 250 mg/500 mg and Placebo in Pain, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This study is being conducted to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to placebo in subjects who are experiencing post operative pain following surgical extraction of 3 or more third molar teeth. A review of any reported adverse events will also be completed.
140 studies on the registry are indexed under Toothache; 24 are open to participants now.
This study's enrollment of 123 is above the median of 100 across 121 interventional studies indexed under Toothache.
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Exclusion Criteria
Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening of the following medical conditions/disorders:
Prior use of any type of analgesic or NSAID within five half lives of that drug or less before taking the first dose of investigational product, except for pre anesthetic medication and anesthesia for the procedure.
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FDC IBU/APAP 250 mg/500 mg
Drug: FDC IBU/APAP 250 mg/500 mg
Placebo
Drug: Placebo
FDC IBU/APAP 250 mg/500 mg
Placebo
Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24])
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 \[0-24\]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Time frame: 0 to 24 hours post dose
Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 \[0-8\]), -15 (worst score) to 30 (best score) for (SPID11 \[6-8\]), -80 (worst score) to 160 (best score) for (SPID11 \[0-16\]), -45 (worst score) to 90 (best score) for (SPID11 \[8-16\]), -240 (worst score) to 480 (best score) for (SPID11 \[0-48\]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
Time frame: 0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose
Duration of Relief After First Dose
Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation.
Time frame: Up to 8 hours after first dose
Time to Onset of "Meaningful" Pain Relief After First Dose
Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first.
Time frame: Up to 8 hours after first dose
| Milestone | Placebo | Ibuprofen 250 mg / Acetaminophen 500 mg |
|---|---|---|
| Started | 41 | 82 |
| Completed | 36 | 76 |
| Not completed | 5 | 6 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Medication error | 1 | 0 |
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 \[0-24\]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
| units on a Scale | Placebo | Ibuprofen 250 mg / Acetaminophen 500 |
|---|---|---|
| Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24]) | -8.13 ± 9.426 | 64.76 ± 6.676 |
Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 \[0-8\]), -15 (worst score) to 30 (best score) for (SPID11 \[6-8\]), -80 (worst score) to 160 (best score) for (SPID11 \[0-16\]), -45 (worst score) to 90 (best score) for (SPID11 \[8-16\]), -240 (worst score) to 480 (best score) for (SPID11 \[0-48\]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).
| units on a scale | Placebo | Ibuprofen 250 mg / Acetaminophen 500 |
|---|---|---|
| 0 to 8 hours | -3.12 ± 2.708 | 23.33 ± 1.918 |
| 6 to 8 hours | -1.46 ± 1.123 | 6.45 ± 0.795 |
| 0 to 16 hours | -6.24 ± 6.028 | 45.43 ± 4.270 |
| 8 to 16 hours | -3.68 ± 3.794 | 23.64 ± 2.687 |
| 0 to 48 hours | -14.97 ± 19.668 | 123.69 ± 13.930 |
Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation.
| minutes | Placebo | Ibuprofen 250 mg / Acetaminophen 500 |
|---|---|---|
| Duration of Relief After First Dose | 82.0 (75.0 to 99.0) | NA (NA to NA) |
Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as "meaningful relief" at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first.
| minutes | Placebo | Ibuprofen 250 mg / Acetaminophen 500 |
|---|---|---|
| Time to Onset of "Meaningful" Pain Relief After First Dose | 165.9 (88.0 to 170.0) | 59.2 (47.7 to 74.5) |
Collected over Baseline up to 28 days after the last dose (up to 30 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/41 (0%) | 0/41 (0%) | 14/41 (34.1%) |
| Ibuprofen 250 mg / Acetaminophen 500 mg | 0/82 (0%) | 0/82 (0%) | 11/82 (13.4%) |
| Event | Placebo | Ibuprofen 250 mg / Acetaminophen 500 mg |
|---|---|---|
| NauseaGastrointestinal disorders | 8/41 | 5/82 |
| VomitingGastrointestinal disorders | 6/41 | 4/82 |
| DizzinessNervous system disorders | 4/41 | 2/82 |
| HeadacheNervous system disorders | 4/41 | 2/82 |
| Vision blurredEye disorders | 1/41 | 0/82 |
| Abdominal painGastrointestinal disorders | 1/41 | 0/82 |
| ConstipationGastrointestinal disorders | 1/41 | 0/82 |
| DyspepsiaGastrointestinal disorders | 1/41 | 0/82 |
| Sensitivity of teethGastrointestinal disorders | 1/41 | 0/82 |
| Arthropod biteInjury, poisoning and procedural complications | 1/41 | 0/82 |
The full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment.
| Age, Continuous(Years) | Placebo | Ibuprofen 250 mg / Acetaminophen 500 mg | Total |
|---|---|---|---|
| Mean | 21.8 ± 4.09 | 21.8 ± 3.73 | 21.8 ± 3.84 |
| Sex: Female, Male(Participants) | Placebo | Ibuprofen 250 mg / Acetaminophen 500 mg | Total |
|---|---|---|---|
| Female | 22 | 45 | 67 |
| Male | 19 | 37 | 56 |
| Race/Ethnicity, Customized(Participants) | Placebo | Ibuprofen 250 mg / Acetaminophen 500 mg | Total |
|---|---|---|---|
| Asian | 0 | 1 | 1 |
| Black or African American | 1 | 2 | 3 |
| White | 35 | 77 | 112 |
| Unknown or Not Reported | 5 | 2 | 7 |
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