E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The current trial was designed to assess whether consumers will exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At least 12 years of age - Report taking OTC analgesics for pain on at least 5 days in the last month - Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it - Able to read and understand English - Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent) - Provide contact information - Purchase the investigational product |
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E.4 | Principal exclusion criteria |
Have participated in a trial involving OTC analgesics in the last 6 months - They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels) - Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.) - Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days - (Female subjects) are pregnant or breastfeeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
Estimated Percentage of Misuse for Non-Therapeutic Reasons |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
•Non-therapeutic Reasons for Misuse
•Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
•Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
•Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
•Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
•Percentage of Dosing Occasions Where More Than One Tablet Was Taken
•Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
•Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The 28-day follow-up telephone interview will occur after completion of Visit 2 or after 28 days (+10 days). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 3 |