Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01427803
Eligibility Criteria:
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
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01427803
Study Brief:
Protocol Section:
NCT01427803