Trial Outcomes & Findings for A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain (NCT NCT02837952)

Last Updated: 2018-03-05

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

123 participants

Primary outcome timeframe

0 to 24 hours post dose

Results posted on

2018-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 mg Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
Overall Study STARTED	41	82
Overall Study COMPLETED	36	76
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 mg Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	4	5
Overall Study Medication Error	1	0

Baseline Characteristics

A Study of Ibuprofen (IBU) 250mg/APAP 500mg In The Treatment Of Post-Surgical Dental Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=41 Participants Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 mg n=82 Participants Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Total n=123 Participants Total of all reporting groups
Age, Continuous	21.8 Years STANDARD_DEVIATION 4.09 • n=5 Participants	21.8 Years STANDARD_DEVIATION 3.73 • n=7 Participants	21.8 Years STANDARD_DEVIATION 3.84 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	45 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	37 Participants n=7 Participants	56 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized White	35 Participants n=5 Participants	77 Participants n=7 Participants	112 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 24 hours post dose

Population: The full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 n=82 Participants Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
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 units on a Scale Standard Error 9.426	64.76 units on a Scale Standard Error 6.676

SECONDARY outcome

Timeframe: 0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose

Population: The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.

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).

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 n=82 Participants Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
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 0 to 8 hours	-3.12 units on a scale Standard Error 2.708	23.33 units on a scale Standard Error 1.918
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 6 to 8 hours	-1.46 units on a scale Standard Error 1.123	6.45 units on a scale Standard Error 0.795
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 0 to 16 hours	-6.24 units on a scale Standard Error 6.028	45.43 units on a scale Standard Error 4.270
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 8 to 16 hours	-3.68 units on a scale Standard Error 3.794	23.64 units on a scale Standard Error 2.687
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 0 to 48 hours	-14.97 units on a scale Standard Error 19.668	123.69 units on a scale Standard Error 13.930

SECONDARY outcome

Timeframe: Up to 8 hours after first dose

Population: The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 n=82 Participants Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
Duration of Relief After First Dose	82.0 minutes Interval 75.0 to 99.0	NA minutes Due to less than 50% of participants who had the event, median and 95% CI was not estimable and hence not reported.

SECONDARY outcome

Timeframe: Up to 8 hours after first dose

Population: The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.

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.

Outcome measures

Outcome measures
Measure	Placebo n=41 Participants Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 n=82 Participants Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
Time to Onset of "Meaningful" Pain Relief After First Dose	165.9 minutes Interval 88.0 to 170.0	59.2 minutes Interval 47.7 to 74.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Ibuprofen 250 mg / Acetaminophen 500 mg

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=41 participants at risk Participants received placebo matched to fixed dose combination of ibuprofen (IBU) / acetaminophen (APAP) (administered as 2 tablets) within 7 minutes of the completion of Baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).	Ibuprofen 250 mg / Acetaminophen 500 mg n=82 participants at risk Participants received fixed dose combination of IBU 250 mg/ APAP 500 mg (administered as 2 tablets of IBU 125 mg/APAP 250 mg) within 7 minutes of the completion of baseline (0 hours on Day 1) pain assessments and, thereafter, every 8 hours up to 40 hours during the study duration of 48 hours. Participants were followed up to 28 days after the last dose of study drug (up to Day 30).
Eye disorders Vision blurred	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Gastrointestinal disorders Abdominal pain	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Gastrointestinal disorders Constipation	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Gastrointestinal disorders Dyspepsia	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Gastrointestinal disorders Nausea	19.5% 8/41 • Baseline up to 28 days after the last dose (up to 30 days)	6.1% 5/82 • Baseline up to 28 days after the last dose (up to 30 days)
Gastrointestinal disorders Sensitivity of teeth	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Gastrointestinal disorders Vomiting	14.6% 6/41 • Baseline up to 28 days after the last dose (up to 30 days)	4.9% 4/82 • Baseline up to 28 days after the last dose (up to 30 days)
General disorders Chest discomfort	0.00% 0/41 • Baseline up to 28 days after the last dose (up to 30 days)	1.2% 1/82 • Baseline up to 28 days after the last dose (up to 30 days)
General disorders Chills	0.00% 0/41 • Baseline up to 28 days after the last dose (up to 30 days)	1.2% 1/82 • Baseline up to 28 days after the last dose (up to 30 days)
Injury, poisoning and procedural complications Arthropod bite	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Nervous system disorders Dizziness	9.8% 4/41 • Baseline up to 28 days after the last dose (up to 30 days)	2.4% 2/82 • Baseline up to 28 days after the last dose (up to 30 days)
Nervous system disorders Headache	9.8% 4/41 • Baseline up to 28 days after the last dose (up to 30 days)	2.4% 2/82 • Baseline up to 28 days after the last dose (up to 30 days)
Psychiatric disorders Anxiety	0.00% 0/41 • Baseline up to 28 days after the last dose (up to 30 days)	1.2% 1/82 • Baseline up to 28 days after the last dose (up to 30 days)
Respiratory, thoracic and mediastinal disorders Cough	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/41 • Baseline up to 28 days after the last dose (up to 30 days)	1.2% 1/82 • Baseline up to 28 days after the last dose (up to 30 days)
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Skin and subcutaneous tissue disorders Swelling face	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)
Vascular disorders Orthostatic hypotension	2.4% 1/41 • Baseline up to 28 days after the last dose (up to 30 days)	0.00% 0/82 • Baseline up to 28 days after the last dose (up to 30 days)