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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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 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 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/or 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/or 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. Cannot read, speak, and/or understand English.

2. Trained or employed as a healthcare professional.

3. 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.

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

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

6. Subjects with the following clinical conditions which place them at excessively high
risk (>10% 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 disease, heart attack, stroke)
or have had heart surgery or who currently have uncontrolled high blood pressure
(either by self-report or 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.

7. 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.

8. 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
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.

9. 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 last dose of investigational product.

10. 18 years of age or older and classified as normal-literacy (REALM Test score of 61 or
greater) after the normal literacy group quotas (approximately 70% of adult subjects)
are full (note there is no corresponding literacy exclusion criterion for adolescent
subjects based on REALM Teen score), or refuses to complete the REALM (adults) or
REALM-Teen (adolescents) Test.

11. 18 years of age or older and classified as moderate (less frequent) pain reliever user
( group quotas (approximately 33% of adult subjects) are full.

12. Not capable of swallowing a vitamin-sized tablet.

13. 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):

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

15. 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.

NCT03722238
Pfizer
Not yet recruiting
Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers

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[email protected]

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Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
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
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.
Not Provided
Interventional
Phase 3
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

Pain
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.
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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
820
Same as current
August 21, 2019
August 21, 2019   (Final data collection date for primary outcome measure)

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 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 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/or 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/or 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. Cannot read, speak, and/or understand English.
  2. Trained or employed as a healthcare professional.
  3. 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.
  4. Participation in other studies involving investigational drug(s) within 6 months prior to study entry and/or during study participation.
  5. Known hypersensitivity to ibuprofen, aspirin, or any other NSAIDs.
  6. Subjects with the following clinical conditions which place them at excessively high risk (>10% 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 disease, heart attack, stroke) or have had heart surgery or who currently have uncontrolled high blood pressure (either by self-report or 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.
  7. 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.
  8. 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 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.
  9. 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 last dose of investigational product.
  10. 18 years of age or older and classified as normal-literacy (REALM Test score of 61 or greater) after the normal literacy group quotas (approximately 70% of adult subjects) are full (note there is no corresponding literacy exclusion criterion for adolescent subjects based on REALM Teen score), or refuses to complete the REALM (adults) or REALM-Teen (adolescents) Test.
  11. 18 years of age or older and classified as moderate (less frequent) 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.
  12. Not capable of swallowing a vitamin-sized tablet.
  13. 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):

  14. Has developmental or learning disabilities that, in the judgment of the parent/guardian or the investigator, would interfere with study participation.
  15. 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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03722238
B4371011
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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