ibuprofen and Bunion studies

Bunion: Abnormal swelling of the inner aspect of the first metatarsal head affecting the first METATARSOPHALANGEAL JOINT.

Research Excerpts

Excerpt	Relevance	Reference
" Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40 mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy) were randomized (3:3:3:2) to receive the FDC (ibuprofen 300 mg + acetaminophen 1000 mg), ibuprofen 300 mg, acetaminophen 1000 mg, or placebo (vehicle), administered as 15-minute intravenous infusions every 6 hours for 48 hours."	9.30	Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial. ( Atkinson, HC; Daniels, SE; Gottlieb, IJ; Playne, R; Stanescu, I; Zhang, J, 2019)
" Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40 mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy) were randomized (3:3:3:2) to receive the FDC (ibuprofen 300 mg + acetaminophen 1000 mg), ibuprofen 300 mg, acetaminophen 1000 mg, or placebo (vehicle), administered as 15-minute intravenous infusions every 6 hours for 48 hours."	5.30	Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial. ( Atkinson, HC; Daniels, SE; Gottlieb, IJ; Playne, R; Stanescu, I; Zhang, J, 2019)

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

"Summed Pain Intensity Difference (SPID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm)."

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Daniels, SE	1
Playne, R	1
Stanescu, I	1
Zhang, J	1
Gottlieb, IJ	1
Atkinson, HC	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Maxigesic IV Bunionectomy Study- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group and Placebo-Controlled Study[NCT02689063]	Phase 3	276 participants (Actual)	Interventional	2016-10-26	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"A Pain Intensity Difference (PID) is the difference between the Visual Analogue Scale (VAS) pain intensity score recorded at baseline and a score recorded at any time after the first dose of study medication. Taken together, a patient's PID scores capture the pain relief profile attributable to the assigned study medication. A high PID score indicates a better pain relief experienced.~The extent of pain relief can then be calculated by the Area Under the Curve the PID scores (also referred to as the Sum of Pain Intensity Differences [SPID]). SPID48 scores were adjusted by the time interval from baseline to the final VAS score used in the SPID, using the following formula:~Time-adjusted SPID48 (mm) = SPID (mm*hr) / Time (hr) In the event that a patient required rescue medication, the SPID was calculated up until the first Pre-Rescue VAS pain assessment (inclusive)." (NCT02689063)
Timeframe: 48 hours after the first dose

"The Percentage of Participants Who Evaluated Their Study Drug as Excellent on a 5-point Categorical Scale Global Evaluation of Study Drug"

Intervention	score on a scale (Mean)
Maxigesic IV	23.4
IV Acetaminophen	10.4
IV Ibuprofen	9.5
Placebo IV	-1.3

"At the end of 48 hours study period, participants will be asked to How do you rate the study medication? on a 5 point categorical scale:~Poor~Fair~Good~Very Good~Excellent The high score means the participants believed that a better treatment for pain relief received." (NCT02689063)
Timeframe: 48 hrs after the first dose

"VAS Pain Intensity Difference (PID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long VAS Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm)."

Intervention	Participants (Count of Participants)
Maxigesic IV	24
IV Acetaminophen	5
IV Ibuprofen	8
Placebo IV	1

"VAS Pain intensity difference (PID) at each scheduled assessment time point after Time 0.~A Pain Intensity Difference (PID) is the difference between the Visual Analogue Scale (VAS) pain intensity score recorded at baseline and a score recorded at any time after the first dose of study medication. Taken together, a patient's PID scores capture the pain relief profile attributable to the assigned study medication. A high PID score indicates a better pain relief experienced." (NCT02689063)
Timeframe: 48 hours after the first dose

"VAS Pain Intensity Score-marking on a 100 mm VAS Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm). A High VAS Score Indicates a More Intensive Pain Level Experienced."

Intervention	score on a scale (Mean)
Maxigesic IV	52.50
IV Acetaminophen	38.95
IV Ibuprofen	45.04
Placebo IV	37.24

"VAS Pain intensity score at each scheduled assessment time point VAS pain intensity score-marking on a 100 mm VAS scale with anchors for no pain (0 mm) and worst pain imaginable (100 mm). A high VAS score indicates a more intensive pain level experienced." (NCT02689063)
Timeframe: 48 hours after the first dose

Number of Participants With Treatment Emergent Adverse Events (AEs)

Intervention	score on a scale (Mean)
Maxigesic IV	18.43
IV Acetaminophen	29.28
IV Ibuprofen	27.21
Placebo IV	28.22

Treatment-emergent Adverse events coded to MedDRA v 20.0 Preferred Term and System Organ Class Code were tabulated as the counts and percentages by treatment group. (NCT02689063)
Timeframe: Day 7

Percentage of Participants Who Obtained a Peak Pain Relief -Value of 3 ('A Lot of Relief') or 4 ('Complete Relief') Prior to the First Dose of Rescue

Intervention	Participants (Count of Participants)
Maxigesic IV	52
IV Acetaminophen	45
IV Ibuprofen	58
Placebo IV	39

"Peak Pain Relief was assessed on Pain Relief scores (on a 5 point categorical rating-please see outcome measure description No. 7) recorded up until the first dose of rescue (First Pre-Rescue Pain Relief score inclusive).~The percentage of participants who achieve the peak pain relief was summarized." (NCT02689063)
Timeframe: 48 hours after the first dose

Percentage of Participants With Complete Pain Relief

Intervention	Participants (Count of Participants)
Maxigesic IV	22
IV Acetaminophen	11
IV Ibuprofen	4
Placebo IV	3

"Pain relief score was assessed on a 5-point categorical scale at each scheduled time point after Time 0:~0 = No pain relief (the pain is the same, or worse, than the starting pain)~= A little pain relief (the pain is less than half gone)~= some pain relief (the pain is about half gone)~= A lot pain relief (the pain is more than half gone)~= Complete pain relief (the pain is completely gone)~Assessed at scheduled time points:~5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6 hours after the first dose of the study drug~Immediately before and 2 hours after each subsequent dose (doses 2-8) of the study drug while awake~At the end of 48 hours of double-blind treatment period~Immediately before taking each dose of the rescue medication if additional analgesia is required.~At the time of withdrawal (if applicable)" (NCT02689063)
Timeframe: 48 hours after the first dose

Percentage of Subjects Using Rescue Medication

Intervention	Participants (Count of Participants)
Maxigesic IV	29
IV Acetaminophen	7
IV Ibuprofen	16
Placebo IV	4

The percentage of participants who used at lease one dose of rescue medication was summarized in each treatment group (NCT02689063)
Timeframe: 48 hrs after the first dose

Time to Peak Pain Relief

Intervention	Participants (Count of Participants)
Maxigesic IV	56
IV Acetaminophen	70
IV Ibuprofen	70
Placebo IV	48

"Time to peak pain relief-Peak Pain Relief was assessed on Pain Relief scores recorded up until the first dose of rescue (First Pre-Rescue Pain Relief score inclusive). Time for participants who experienced peak pain relief was summarized.~Note: For the reader to interpret this outcome measure, a very short Time to Peak Pain Relief indicates the absence of analgesic effect for a treatment because peak pain relief was determined prior to the first dose of rescue medication (or 48 hours if no rescue medication was used)." (NCT02689063)
Timeframe: 48 hrs after the first dose

Time to the First Dose of Rescue Medication

Intervention	hours (Mean)
Maxigesic IV	4.00
IV Acetaminophen	2.46
IV Ibuprofen	1.47
Placebo IV	0.91

Time to first use of rescue medication (duration of analgesia) (NCT02689063)
Timeframe: 48 hrs

Time to the Onset of Analgesia-Time to Onset of Analgesia (Measured as Time to Perceptible Pain Relief Confirmed by Meaningful Pain Relief) Using the Two-stopwatch Method

Intervention	hours (Mean)
Maxigesic IV	12.98
IV Acetaminophen	5.62
IV Ibuprofen	3.09
Placebo IV	2.92

"Two-stopwatch method~Start two stopwatches ('Stopwatch A' and 'Stopwatch B') at the same time that the infusion of study drug is initiated. This is Time 0.~The participant is given 'Stopwatch A' and instructed to Stop 'Stopwatch A' when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now. (Perceptible Pain Relief)~When the participant stops the 'Stopwatch A', the participant then was asked Do you consider the pain relief you experienced meaningful?~If the participant answered No, then the participant was given the Stopwatch B and instructed to Stop 'Stopwatch B' when you feel the pain relief is meaningful to you (Meaningful Pain Relief)~If the subject did not experience perceptible pain relief, they would retain 'Stopwatch A' for the entire 6 hour evaluation period." (NCT02689063)
Timeframe: 6 hours

SPID-6, SPID-12, SPID-24-VAS SPID Over 0 to 6 Hours (SPID-6), Over 0 to 12 Hours (SPID-12), and Over 0 to 24 Hours (SPID-24) After Time 0 (=the First Dose)

Intervention	minutes (Median)
Maxigesic IV	9.4
IV Acetaminophen	23.9
IV Ibuprofen	13.8
Placebo IV	0

"Time adjusted SPID-6, SPID-12, SPID-24 were derived in a similar manner to the Time-adjusted SPID-48 (i.e. up until the first Pre-Rescue VAS inclusive). Please see the primary outcome measure descriptions.~Each of these variables were derived from VAS (Visual Analogue Scale) scores recorded prior to the first dose of rescue medication in the first 6 (to calculate SPID6), 12 (to calculate SPID12) or 24 hours (to calculate SPID24) of the study.~VAS pain intensity scores were obtained by marking on a 100 mm VAS scale with anchors for no pain (0 mm) and worst pain imaginable (100 mm). The VAS was completed at rest." (NCT02689063)
Timeframe: 6, 12, 24 hours after the first dose

Total Use of Rescue Medication

Intervention	score on a scale (Mean)
	SPID 6	SPID 12	SPID 24
IV Acetaminophen	10.13	9.42	9.59
IV Ibuprofen	9.01	8.44	8.64
Maxigesic IV	20.10	20.63	21.99
Placebo IV	-1.49	-1.66	-1.54

Total use of rescue analgesia over 0 to 24 hours and over 0 to 48 hours (NCT02689063)
Timeframe: 24, 48 hrs after the first dose

TOTPAR-6, TOTPAR-12, TOTPAR-24, TOTPAR-48

Intervention	mg (Mean)
	Total Dose in 48 hrs	Total Dose in 24 hrs
IV Acetaminophen	33.1	23.7
IV Ibuprofen	32.4	22.1
Maxigesic IV	22.9	17.2
Placebo IV	44.7	29.6

"Total Pain Relief (TOTPAR) is a measure of total Area Under the Curve of Pain Relief scores. In the event that a patient required rescue medication, the TOTPAR endpoints were calculated using Pain Relief Assessments recorded prior to the first dose of rescue (i.e. inclusive of the first pre-rescue Pain Relief score).~Pain relief scores were obtained by marking on a 5-point categorical rating at scheduled time points.~The high score means more pain relief experienced:~0 = No pain relief (the pain is the same, or worse, than the starting pain)~= A little pain relief (the pain is less than half gone)~= some pain relief (the pain is about half gone)~= A lot pain relief (the pain is more than half gone)~= Complete pain relief (the pain is completely gone) Each of these variables were derived from pain relief scores recorded prior to the first dose of rescue medication in the first 6 (0-48), 12 (0-48), 24 (0-48) or 48 (0-48) hours of the study." (NCT02689063)
Timeframe: 6, 12, 24, 48 hours after the first dose

Intervention	score on a scale*hour (Mean)
	TOTPAR 6	TOTPAR 12	TOTPAR 24	TOTPAR 48
IV Acetaminophen	4.59	6.74	8.66	13.28
IV Ibuprofen	3.34	4.46	6.51	11.95
Maxigesic IV	6.84	11.86	22.13	43.98
Placebo IV	1.60	1.82	2.49	4.51