ibuprofen and Bunion

ibuprofen has been researched along with Bunion in 1 studies

Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine

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

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)."

"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"

"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)."

"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."

"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)

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

"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

"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

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

"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

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

"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)

"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

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

"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

Trials

1 trial available for ibuprofen and Bunion