Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers

NCT03722238

Last updated date
Study Location
Buckeye Drugs
Lebanon, Tennessee, 37087, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Male or female 18 years of age or older, has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months, and qualifies for inclusion in at least one risk group category, including cardiovascular, gastrointestinal bleeding, history of severe pain (≥5 episodes in last month) or >65 years of age (see Groups 1 4 in Section 3.1).

OR Male or female 12-17 years of age and has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months.

2. Evidence of a personally signed and dated informed consent document (ICD), and in the case of minor adolescent subjects (12-17 years of age or adolescent subjects residing in states where the age of majority is > than 18), an assent document, indicating that the subject and where applicable a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.

3. Willing and able to comply with scheduled visits, treatment plan, and other study procedures.

4. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to purchase study medication.

5. Agrees the product purchased is for subject's own use and not to be shared.

6. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to provide contact information for follow up purposes.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Subjects with any of the following characteristics/conditions will not be included in the
study:


1. Subject (or parent/guardian, if applicable) cannot read, speak, and/or understand
English.


2. Trained or employed as a healthcare professional.


3. Subject or someone else in the household is employed by a pharmaceutical company,
medical practice or hospital, pharmacy, managed care or health insurance organization
or a contract research organization.


4. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
potential subjects who are Pfizer employees, including their family members, directly
involved in the conduct of the study.


5. Participation in other studies involving investigational drug(s) within 6 months prior
to study entry and/or during study participation.


6. Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs.


7. Subjects with the following clinical conditions which place them at excessively high
risk or have ≥20% 10 year risk for atherosclerotic cardiovascular disease (ASCVD), as
defined by the 2013 ACC/AHA Guidelines on the Assessment of Atherosclerotic
Cardiovascular Risk, will not be included in the study: clinically established
coronary heart disease; cerebrovascular disease; peripheral artery disease; abdominal
aortic aneurysm; and chronic kidney disease. Subjects who have experienced a prior non
fatal cardiovascular disease event (angina, heart failure, heart disease, heart
attack, stroke/transient ischemic attack) or have had heart surgery or who currently
have uncontrolled high blood pressure (either by self report or by measured systolic
blood pressure higher than 180 mmHg or diastolic pressure higher than 120 mmHg at the
time of the enrollment interview), will also be excluded from the study.


8. Subjects with concurrent or recent (within 30 days) use of anticoagulants, a prior
history of complicated peptic ulcer, or a gastrointestinal bleeding event requiring
hospitalization or blood transfusion.


9. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product (IP)
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.


10. Pregnant female subjects; breastfeeding female subjects; and male and female subjects
of childbearing potential who are unwilling or unable to use a highly effective method
of contraception as outlined in this protocol for the duration of the study and for 28
days after the end of their 30-Day Use Phase or, for subjects who use the
investigational product after Day 30, 28 days after the last recorded dose of
investigational product.


11. 18 years of age or older and classified as normal literacy (REALM Test score ≥61)
after the normal literacy group quotas (approximately 70% of adult subjects) are full
or refuses to complete the REALM Test (note there is no corresponding literacy
exclusion criterion for adolescent subjects based on REALM Teen score).


12. 18 years of age or older and classified as moderate (less frequent) oral OTC pain
reliever user (<30 doses per month on average in the preceding 3 months) after the
moderate user group quotas (approximately 33% of adult subjects) are full.


13. Not capable of swallowing a vitamin sized tablet.


14. Refuses to participate in required assessments (such as urine pregnancy, finger stick
cholesterol or blood pressure tests, or unable or unwilling to comply with electronic
diary procedures).


The following additional exclusion criteria will be applied for adolescent subjects
only (12-17 years of age):


15. Has developmental or learning disabilities that, in the judgment of the
parent/guardian or the investigator, would interfere with study participation.


16. Another adolescent child from the family is already enrolled into the study, or
parent/guardian does not agree that only one adolescent child from the family or
household will be enrolled into the study.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

PainAn Open-Label Study Of Celecoxib In Patients With Posttraumatic Pain
NCT00976716
  1. Funabashi, Chiba
  2. Ichikawa, Chiba
  3. Matsudo, Chiba
  4. Sagamihara, Kanagawa
  5. Ageo, Saitama
  6. Saitama-shi, Saitama
  7. Edogawaku, Tokyo
  8. Kotoku, Tokyo
  9. Nerimaku, Tokyo
  10. Toshimaku, Tokyo
  11. Kofu, Yamanashi
ALL GENDERS
20 Years+
years
MULTIPLE SITES
PainA Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
NCT00651300
  1. Port Macquarie, New South Wales
  2. Randwick, New South Wales
  3. Westmead, New South Wales
  4. Coopers Plain, Queensland
  5. Townsville, Queensland
  6. Heidelberg, Victoria
  7. Prahran, Victoria
  8. Perth, Western Australia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PainPlacebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
NCT00159640
  1. Warrawong, New South Wales
  2. Westmead, New South Wales
  3. Kippa Ring, Queensland
  4. Maroochydore, Queensland
  5. Bedford Park, South Australia
  6. Perth, Western Australia
  7. Woodville,
  8. Kelowna, British Columbia
  9. Halifax, Nova Scotia
  10. Toronto, Ontario
  11. Sherbrooke, Quebec
  12. Ste-foy, Quebec
  13. Brno,
  14. Ceske Budejovice,
  15. CZ-Praha 8,
  16. Plzen,
  17. Praha 5,
  18. Arnhem,
  19. Breda,
  20. Kampen,
  21. Roosendaal,
  22. Rotterdam,
  23. Stadskanaal,
  24. Barcelona,
  25. Granada,
  26. Madrid,
  27. Malaga,
  28. Sevilla,
  29. Portsmouth, Hants
  30. Northampton, Northants
  31. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
PainStudy Comparing the Efficacy of Two Ibuprofen Formulations
NCT00740857
  1. Salt Lake City, Utah
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
Official Title  ICMJE MULTICENTER ACTUAL USE AND COMPLIANCE STUDY OF IBUPROFEN 600 MG IMMEDIATE RELEASE/EXTENDED RELEASE TABLETS AMONG TARGETED (AT-RISK) CONSUMERS IN A SIMULATED OVER-THE-COUNTER ENVIRONMENT
Brief Summary This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (>65 years of age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular (CV) adverse events, consumers who experience severe pain, low literacy subjects, and adolescents (12-17 years of age). The total number of subjects expected to enroll into the study is approximately 820. Sites will be pharmacies in diverse geographic locations around the US. Prospective adult subjects will be recruited via general population and targeted risk condition advertising (although participants will not be informed as to specific health conditions for which they are being recruited), while adolescents will be recruited using targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of prospective adolescent subjects) responding to the advertisements or recruitment calls will be initially screened by telephone, and eligibility will subsequently be verified in-person at the pharmacy site.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Intervention Model Description:
The Actual Use Trial (AUT) design utilizes a real world setting to assess the ability of consumers to use an investigational product that will be marketed in an over-the-counter setting according to the proposed product labelling. The primary objective of this AUT is to evaluate compliance with the labeled dosing directions for Advil 12 Hour and to understand why misuse occurred and if it was a conscious decision by the subject. A secondary objective is to evaluate the safety of Advil 12 Hour in unsupervised actual use and how it relates to misuse.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Pain
Intervention  ICMJE Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Ibuprofen 600 mg Immediate Release/Extended Release Tablet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
Study Arms  ICMJE Experimental: Ibuprofen 600 mg Immediate Release/Extended Release Tablets
Ibuprofen 600 mg Immediate Release/Extended Release Tablets
Intervention: Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 25, 2018)
820
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2020
Estimated Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  1. Male or female 18 years of age or older, has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months, and qualifies for inclusion in at least one risk group category, including cardiovascular, gastrointestinal bleeding, history of severe pain (?5 episodes in last month) or >65 years of age (see Groups 1 4 in Section 3.1).

    OR Male or female 12-17 years of age and has history of using oral OTC analgesics at OTC dose levels, defined as taking at least 5 doses/month on average during the past 3 months.

  2. Evidence of a personally signed and dated informed consent document (ICD), and in the case of minor adolescent subjects (12-17 years of age or adolescent subjects residing in states where the age of majority is > than 18), an assent document, indicating that the subject and where applicable a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study.
  3. Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  4. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to purchase study medication.
  5. Agrees the product purchased is for subject's own use and not to be shared.
  6. Willing (or in the case of adolescent subjects, the parent/guardian is willing) and able to provide contact information for follow up purposes.

Exclusion Criteria

Subjects with any of the following characteristics/conditions will not be included in the study:

  1. Subject (or parent/guardian, if applicable) cannot read, speak, and/or understand English.
  2. Trained or employed as a healthcare professional.
  3. Subject or someone else in the household is employed by a pharmaceutical company, medical practice or hospital, pharmacy, managed care or health insurance organization or a contract research organization.
  4. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or potential subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  5. Participation in other studies involving investigational drug(s) within 6 months prior to study entry and/or during study participation.
  6. Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs.
  7. Subjects with the following clinical conditions which place them at excessively high risk or have ?20% 10 year risk for atherosclerotic cardiovascular disease (ASCVD), as defined by the 2013 ACC/AHA Guidelines on the Assessment of Atherosclerotic Cardiovascular Risk, will not be included in the study: clinically established coronary heart disease; cerebrovascular disease; peripheral artery disease; abdominal aortic aneurysm; and chronic kidney disease. Subjects who have experienced a prior non fatal cardiovascular disease event (angina, heart failure, heart disease, heart attack, stroke/transient ischemic attack) or have had heart surgery or who currently have uncontrolled high blood pressure (either by self report or by measured systolic blood pressure higher than 180 mmHg or diastolic pressure higher than 120 mmHg at the time of the enrollment interview), will also be excluded from the study.
  8. Subjects with concurrent or recent (within 30 days) use of anticoagulants, a prior history of complicated peptic ulcer, or a gastrointestinal bleeding event requiring hospitalization or blood transfusion.
  9. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product (IP) administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  10. Pregnant female subjects; breastfeeding female subjects; and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the end of their 30-Day Use Phase or, for subjects who use the investigational product after Day 30, 28 days after the last recorded dose of investigational product.
  11. 18 years of age or older and classified as normal literacy (REALM Test score ?61) after the normal literacy group quotas (approximately 70% of adult subjects) are full or refuses to complete the REALM Test (note there is no corresponding literacy exclusion criterion for adolescent subjects based on REALM Teen score).
  12. 18 years of age or older and classified as moderate (less frequent) oral OTC pain reliever user (<30 doses per month on average in the preceding 3 months) after the moderate user group quotas (approximately 33% of adult subjects) are full.
  13. Not capable of swallowing a vitamin sized tablet.
  14. Refuses to participate in required assessments (such as urine pregnancy, finger stick cholesterol or blood pressure tests, or unable or unwilling to comply with electronic diary procedures).

    The following additional exclusion criteria will be applied for adolescent subjects only (12-17 years of age):

  15. Has developmental or learning disabilities that, in the judgment of the parent/guardian or the investigator, would interfere with study participation.
  16. Another adolescent child from the family is already enrolled into the study, or parent/guardian does not agree that only one adolescent child from the family or household will be enrolled into the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03722238
Other Study ID Numbers  ICMJE B4371011
MARATHON AUT ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP