Patient CompliancePhase 3NCT02294019
Actual Use Trial of Ibuprofen 400 mg
A Phase 3 study testing Ibuprofen 400 mg caplet in people with Patient Compliance, run by Pfizer at 25 sites in United States.
Trial summary
This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Compliance
- What is being tested?
- Ibuprofen 400 mg caplet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 738 participants
- Where
- 25 sitesUnited States
- Study dates
- Nov 2014to May 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age (19 years of age in Alabama)
- Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief
Who cannot join
- Current government-issued identification (ID)
- Pregnant or breastfeeding females
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Phil's Pills, Inc.
Albuquerque, New Mexico, 87110
Goodrich Pharmacy
Andover, Minnesota, 55304
Goodrich Pharmacy
Anoka, Minnesota, 55303
Family Prescription Center
Bethlehem, Pennsylvania, 18015
Goodrich Pharmacy
Blaine, Minnesota, 55434
The Medicine Shoppe
Bountiful, Utah, 84010
Kroger Pharmacy #342
Cary, North Carolina, 27513
Sutton Family Pharmacy
Dalton, Georgia, 30721
Goodrich Pharmacy
Elk River, Minnesota, 55330
Foothills Compounding Pharmacy
Enumclaw, Washington, 98022
Garden Drug
Fort Lauderdale, Florida, 33309
Wynn's Pharmacy Inc.
Griffin, Georgia, 30224
Robert's Discount Pharmacy
Hoover, Alabama, 35226
Albers' Specialty Pharmacy
Kansas City, Missouri, 64111
Ostrom Drugs
Kenmore, Washington, 98028
Northview Pharmacy
Layton, Utah, 84041
Pharmacy at the Pig
McCalla, Alabama, 35111
Community Clinical Pharmacy
Mesa, Arizona, 85202
Texas Road Pharmacy
Monroe, New Jersey, 08831
Pill Box Pharmacy and Medical Supply
Pembroke Pines, Florida, 33026
Summerfield Pharmacy
Riverview, Florida, 33569
Cub Pharmacy Number 1924
Saint Louis Park, Minnesota, 55426
Countryside Pharmacy
Savannah, Missouri, 64485
Total Health and Wellness Center of Taos
Taos, New Mexico, 87571
Family Plaza Pharmacy
West Jordan, Utah, 84088
About this study
Official title: A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment
This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.
- Conditions
- Patient Compliance
- Being tested
- Ibuprofen 400 mg caplet
- Keywords
- ibuprofen 400 mg, actual use, compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mg capletDrug
400 milligram (mg) caplet according to Drug Facts label
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen caplet arm | Experimental | Not described Receives: Drug: Ibuprofen 400 mg caplet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.
Measured: Day 1 up to 30 days
Secondary outcomes (1)
Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.
Measured: Day1 up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patient ComplianceStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Masking
- None (open label)
- Enrolment
- 738 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294019
- Sponsor's protocol ID
- B3491013
- Other IDs
- AUT
- Status last verified
- Apr 2016
- First submitted
- 14 Nov 2014
- Last updated
- 30 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment
- ClinicalTrials.gov ID
- NCT02294019
- Acronym / sponsor ID
- B3491013
- Conditions
- Patient Compliance
- Keywords
- ibuprofen 400 mg, actual use, compliance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 738 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.
Study design
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen caplet arm | Experimental | Drug: Ibuprofen 400 mg caplet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female at least 18 years of age (19 years of age in Alabama)
- Subject reports taking over-the-counter (OTC) analgesics for pain or fever relief
Key exclusion criteria (2 listed)
- Current government-issued identification (ID)
- Pregnant or breastfeeding females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 400 mg caplet400 milligram (mg) caplet according to Drug Facts label | Drug | Ibuprofen caplet arm |
Primary outcome
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
Time frame: Day 1 up to 30 days
Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.
1 secondary outcome
Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
Time frame: Day1 up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen 400 mg caplet in people with Patient Compliance, run by Pfizer at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study (time frame: Day 1 up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.