Analgesia
Conditions
Keywords
Self-selection and actual use/compliance trial.
Brief summary
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.
Interventions
Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 12 years of age * use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months * provide written informed consent (subjects 12-\<18 years of age provide a written assent and parent/guardian will provide written informed consent) * capable of and willing to swallow the study medication
Exclusion criteria
* participated in other research studies in the last 6 months * they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study * have a history of known allergies to ibuprofen, aspirin, or other NSAIDs * have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days * female subjects are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Medication | 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. |
| 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 Opportunity | 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. |
| Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours | 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. |
| Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours | 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. |
| Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg | 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. |
| 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 mg | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms | Day 1 up to Day 30 | In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported. |
| Average Daily Dose Among Excessive Users | 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. |
| Maximum Daily Dose of Study Medication | Day 1 up to Day 30 | — |
| Average Daily Dose of Study Medication | Day 1 up to Day 30 | — |
| Number of Dosing Days Among Inappropriate Users | 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. |
| Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users | 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. |
| Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram | 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. |
| Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms | 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. |
| Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram | Day 1 up to Day 30 | In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self-Selection Arm Participants who were enrolled in the self-selection arm and completed the self-selection questionnaire were made to either select or deselect Ibuprofen 200 milligram (mg) immediate release (IR) or 600 mg IR or extended release (ER) tablets, or to deselect both the products based on their current painful condition. Participants enrolled in this arm did not receive any study medication. | 251 |
| Compliance Arm Participants enrolled in compliance arm, received at least one dose of 600 mg IR or ER tablet of Ibuprofen over a period of 30 days and returned the diary cards, or if any information on dosing was available. | 832 |
| Total | 1,083 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Reasons | 17 | 6 |
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Ineligible | 6 | 2 |
| Overall Study | Ineligible or not Willing to Continue | 0 | 348 |
| Overall Study | Lost to Follow-up | 0 | 14 |
| Overall Study | No Study Medication Taken | 0 | 1 |
| Overall Study | Participant not Purchased the Product | 0 | 20 |
| Overall Study | Protocol Violation | 0 | 55 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Self-Selection Arm | Compliance Arm | Total |
|---|---|---|---|
| Age, Customized Greater Than or Equal to (>=) 18 years | 247 participants | 827 participants | 1074 participants |
| Age, Customized Less Than (<)18 years | 2 participants | 5 participants | 7 participants |
| Age, Customized Unknown | 2 participants | 0 participants | 2 participants |
| Sex/Gender, Customized Female | 114 participants | 408 participants | 522 participants |
| Sex/Gender, Customized Male | 114 participants | 403 participants | 517 participants |
| Sex/Gender, Customized Unknown | 23 participants | 21 participants | 44 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 163 / 405 |
| serious Total, serious adverse events | 1 / 405 |
Outcome results
Primary
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 Opportunity
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.
Time frame: Day 1
Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-Selection Arm | 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 Opportunity | 82.7 percentage of participants |
Primary
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 Medication
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.
Time frame: Day 1
Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-Selection Arm | 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 Medication | 69.1 percentage of participants |
Primary
Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours
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.
Time frame: Day 1
Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-Selection Arm | Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours | 20.9 percentage of participants |
Primary
Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours
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.
Time frame: Day 1
Population: This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-Selection Arm | Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours | 63.2 percentage of participants |
Primary
Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg
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.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-Selection Arm | Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg | 1.2 percentage of participants |
Primary
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 mg
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.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-Selection Arm | 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 mg | 0 percentage of participants |
Secondary
Average Daily Dose Among Excessive Users
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.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. 'N' is participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Average Daily Dose Among Excessive Users | 1821.1 milligram | Standard Deviation 157.4 |
Secondary
Average Daily Dose of Study Medication
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Average Daily Dose of Study Medication | 781.0 milligram | Standard Deviation 229.3 |
Secondary
Maximum Daily Dose of Study Medication
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Maximum Daily Dose of Study Medication | 1147.9 milligram | Standard Deviation 604.43 |
Secondary
Number of Dosing Days Among Inappropriate Users
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.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. 'N' is participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Number of Dosing Days Among Inappropriate Users | 14.8 days | Standard Deviation 8.1 |
Secondary
Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram
In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram | 1.48 dosing occasions | Standard Deviation 4.185 |
Secondary
Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms
In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms | 0.83 dosing occasions | Standard Deviation 3.02 |
Secondary
Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users
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.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. 'N' is participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-Selection Arm | Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users | Single dose | 13.1 pain episodes | Standard Deviation 7.4 |
| Self-Selection Arm | Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users | Multiple dose | 1.8 pain episodes | Standard Deviation 2.6 |
Secondary
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram
Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram | 0.31 days | Standard Deviation 1.188 |
Secondary
Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms
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.
Time frame: Day 1 up to Day 30
Population: This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-Selection Arm | Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms | 0.12 days | Standard Deviation 0.637 |