12 and older, any sex, with Analgesia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study MedicationPrimary· Day 1
Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\<) 6 hours, if left untreated.
Group
Value
95% CI
Self-Selection Arm
69.1
63.3 – 74.8
Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed OpportunityPrimary· Day 1
Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of \<6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain \>=6 hours.
Group
Value
95% CI
Self-Selection Arm
82.7
77.6 – 87.8
Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 HoursPrimary· Day 1
Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \<6 hours were reported in this outcome measure.
Group
Value
95% CI
Self-Selection Arm
63.2
47.8 – 78.5
Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 HoursPrimary· Day 1
Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.
Group
Value
95% CI
Self-Selection Arm
20.9
15.4 – 26.3
Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mgPrimary· Day 1 up to Day 30
Percentage of participants with the use of study medication for \>10 days with an average daily dose of \>1600 mg were reported in this outcome measure.
Group
Value
95% CI
Compliance Arm
1.2
0.2 – 2.3
Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mgPrimary· Day 1 up to Day 30
Percentage of participants who used the study medication for \<=10 days and used more than 20 tablets with an average daily dose of \>1600 mg were reported in this outcome measure.
Group
Value
95% CI
Compliance Arm
0
0 – 0
Average Daily Dose Among Excessive UsersSecondary· Day 1 up to Day 30
Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of \>1600 mg or all participants who used the study medication for \<=10 days during study period, used more than 20 tablets and had an average daily dose of \>1600 mg.
Group
Value
95% CI
Compliance Arm
1821.1
± 157.4
Number of Dosing Days Among Inappropriate UsersSecondary· Day 1 up to Day 30
Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \<6 hours, if left untreated, based on the information provided at the follow up interview.
Group
Value
95% CI
Compliance Arm
14.8
± 8.1
Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate UsersSecondary· Day 1 up to Day 30
In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of \<6 hours, based on the information provided at the follow up interview.
Single dose
Group
Value
95% CI
Compliance Arm
13.1
± 7.4
Multiple dose
Group
Value
95% CI
Compliance Arm
1.8
± 2.6
Number of Treatment Days Exceeding the Daily Dose of 1200 MilligramSecondary· Day 1 up to Day 30
Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.
Group
Value
95% CI
Compliance Arm
0.31
± 1.188
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe SymptomsSecondary· Day 1 up to Day 30
In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.
Group
Value
95% CI
Compliance Arm
0.12
± 0.637
Number of Dosing Occasions Exceeding the Single Dose of 600 MilligramSecondary· Day 1 up to Day 30
In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.
Group
Value
95% CI
Compliance Arm
1.48
± 4.185
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 28 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01789606.