check_circleStudy Completed
Pain
Bayer Identifier:infoA unique number for a trial given by Bayer.
15833
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
Self Selection Trial of Naproxen Sodium
Trial purpose
A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.
Key Participants Requirements
Sex
BothAge
12 - N/ATrial summary
Enrollment Goal info
253The overall number of participants needed for a trial.
Trial Dates info
July 2011 - August 2011Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Aleve (Naproxen Sodium ER, BAY117031)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
YesA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Completed | B & B Pharmacy | Yorba Linda, 92886, United States |
Completed | Medical Arts Rexall Pharmacy | Anaheim, 92801, United States |
Completed | Pill Box Pharmacy | Pembroke Pines, 33026, United States |
Completed | Wynn's Pharmacy | Griffin, 30224, United States |
Completed | Setzer Pharmacy | Roseville, 55113, United States |
Completed | Goodrich Pharmacy | Andover, 55304, United States |
Completed | The Medicine Shoppe | Bountiful, 84010, United States |
Completed | Family Plaza Pharmacy | West Jordan, 84088, United States |
Completed | Rxtra Care U & I | Bellevue, 98007, United States |
Completed | Kelley-Ross Pharmacy | Seattle, 98122, United States |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- The percentage of participants who selected Naproxen Sodium ER and expected their pain to last more than 12 hoursdate_rangeTime Frame:Up to 14 daysenhanced_encryptionNoSafety Issue:
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- The percentage of participants who selected Naproxen Sodium ER , expected their pain to last more than 12 hours and reported their selection decision within first 24 hoursdate_rangeTime Frame:Within 24 hours of their selection decision taken up to 14 daysenhanced_encryptionNoSafety Issue:
- The percentage of low literacy participants who selected Naproxen Sodium ER and expected their pain to last more than 12 hoursdate_rangeTime Frame:Up to 14 daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
OtherThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
1A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.
Additional Information
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