Phase 3
Completed N=1,083
Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet
Analgesia
Source: ClinicalTrials.gov NCT01789606 ↗
Enrolled (actual)
1,083
Serious AEs
0.3%
Results posted
Aug 2017
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
8citations · ~1 / year
Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet.
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.
Linked Publications
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Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
69.1 | — |
| 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 |
82.7 | — |
| PRIMARY 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 | — |
| 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 |
20.9 | — |
| 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 |
1.2 | — |
| 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 |
— | — |
| SECONDARY Average Daily Dose Among Excessive Users |
1821.1 | — |
| SECONDARY Number of Dosing Days Among Inappropriate Users |
14.8 | — |
| SECONDARY Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users |
13.1; 1.8 | — |
| SECONDARY Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram |
0.31 | — |
| SECONDARY Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms |
0.12 | — |
| SECONDARY Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram |
1.48 | — |
| SECONDARY Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms |
0.83 | — |
| SECONDARY Average Daily Dose of Study Medication |
781.0 | — |
| SECONDARY Maximum Daily Dose of Study Medication |
1147.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01789606) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.