Trial · NCT01789606
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
NCT01789606, Phase 3, Completed, Pfizer; results first posted 2017-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet. Trials, record NCT01789606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01789606
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
- NCT number
- NCT01789606
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,083 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Analgesia
- Interventions
- Ibuprofen 600 mg Immediate Release/Extended Release Caplet
- First posted
- 2013-02-12
- Last updated
- 2017-08-28
- Results first posted
- 2017-08-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| 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 | 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. |
| Primary | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Day 1 | 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. | percentage of participants | NUMBER |
| 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 | Day 1 | 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. | percentage of participants | NUMBER |
| PRIMARY | 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 | 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. | percentage of participants | NUMBER |
| 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 | Day 1 | 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. | percentage of participants | NUMBER |
| 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 | Day 1 up to Day 30 | 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. | percentage of participants | NUMBER |
| 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 | Day 1 up to Day 30 | 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. | percentage of participants | NUMBER |
| SECONDARY | Average Daily Dose Among Excessive Users | Day 1 up to Day 30 | 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. | milligram | MEAN |
| SECONDARY | Number of Dosing Days Among Inappropriate Users | Day 1 up to Day 30 | 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. | days | MEAN |
| SECONDARY | Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users | Day 1 up to Day 30 | 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. | pain episodes | MEAN |
| SECONDARY | Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram | Day 1 up to Day 30 | 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. | days | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Self-Selection Arm | 69.1 | 95% Confidence Interval 63.3 to 74.8 | percentage of participants | |
| 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 | Self-Selection Arm | 82.7 | 95% Confidence Interval 77.6 to 87.8 | percentage of participants | |
| Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours | Self-Selection Arm | 63.2 | 95% Confidence Interval 47.8 to 78.5 | percentage of participants | |
| 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 | Self-Selection Arm | 20.9 | 95% Confidence Interval 15.4 to 26.3 | percentage of participants | |
| Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg | Compliance Arm | 1.2 | 95% Confidence Interval 0.2 to 2.3 | percentage of participants | |
| 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 | Compliance Arm | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Average Daily Dose Among Excessive Users | Compliance Arm | 1821.1 | Standard Deviation 157.4 | milligram | |
| Number of Dosing Days Among Inappropriate Users | Compliance Arm | 14.8 | Standard Deviation 8.1 | days | |
| Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users | Compliance Arm | Single dose | 13.1 | Standard Deviation 7.4 | pain episodes |
| Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users | Compliance Arm | Multiple dose | 1.8 | Standard Deviation 2.6 | pain episodes |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Self-Selection Arm | 251 | |
| Overall Study | STARTED | Compliance Arm | 832 | |
| Overall Study | COMPLETED | Self-Selection Arm | 228 | |
| Overall Study | COMPLETED | Compliance Arm | 382 | |
| Overall Study | NOT COMPLETED | Self-Selection Arm | 23 | |
| Overall Study | NOT COMPLETED | Compliance Arm | 450 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ear pain | Ear and labyrinth disorders | Compliance Arm | 2 | 405 | |
| other | Vision blurred | Eye disorders | Compliance Arm | 1 | 405 | |
| other | Visual acuity reduced | Eye disorders | Compliance Arm | 1 | 405 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Compliance Arm | 2 | 405 | |
| other | Abdominal pain | Gastrointestinal disorders | Compliance Arm | 1 | 405 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Compliance Arm | 6 | 405 | |
| other | Constipation | Gastrointestinal disorders | Compliance Arm | 1 | 405 | |
| other | Diarrhoea | Gastrointestinal disorders | Compliance Arm | 3 | 405 | |
| other | Dyspepsia | Gastrointestinal disorders | Compliance Arm | 2 | 405 | |
| other | Flatulence | Gastrointestinal disorders | Compliance Arm | 2 | 405 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Compliance Arm | ||
| Total, other adverse events | Compliance Arm | 163 | 405 |
| Total, serious adverse events | Compliance Arm | 1 | 405 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27184785 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01789606
GET https://conductscience.org/api/trials/v1/NCT01789606/events?page=2