Trial Outcomes & Findings for Actual Use Trial of Ibuprofen 400 mg (NCT NCT02294019)
NCT ID: NCT02294019
Last Updated: 2016-05-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
738 participants
Primary outcome timeframe
Day 1 up to 30 days
Results posted on
2016-05-30
Participant Flow
Participants were screened by phone,then referred to their participating retail pharmacy site for scheduled face-to-face interview,after which they were given an empty ibuprofen 400 milligram (mg) caplet over-the-counter (OTC) package to review information on outside of entire package,then decision was made to purchase medicine by them.
Participant milestones
| Measure |
Ibuprofen
All participants who purchased at least 1 carton of study medication.
|
|---|---|
|
Overall Study
STARTED
|
738
|
|
Overall Study
COMPLETED
|
635
|
|
Overall Study
NOT COMPLETED
|
103
|
Reasons for withdrawal
| Measure |
Ibuprofen
All participants who purchased at least 1 carton of study medication.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
68
|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
Other
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Actual Use Trial of Ibuprofen 400 mg
Baseline characteristics by cohort
| Measure |
Ibuprofen
n=738 Participants
All participants who purchased at least 1 carton of study medication.
|
|---|---|
|
Age, Continuous
|
53.5 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
412 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
326 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 30 daysPopulation: Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
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.
Outcome measures
| Measure |
Ibuprofen
n=685 Participants
Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
|
|---|---|
|
Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
|
95.2 percentage of participants
Interval 93.6 to 96.8
|
SECONDARY outcome
Timeframe: Day1 up to 30 daysPopulation: Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
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.
Outcome measures
| Measure |
Ibuprofen
n=685 Participants
Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
|
|---|---|
|
Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
|
84.4 percentage of participants
Interval 81.7 to 87.1
|
Adverse Events
Ibuprofen (Safety Population)
Serious events: 6 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibuprofen (Safety Population)
n=736 participants at risk
Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
|
|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Atypical pneumonia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Ibuprofen (Safety Population)
n=736 participants at risk
Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
|
|---|---|
|
Cardiac disorders
Palpitations
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye irritation
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.41%
3/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.54%
4/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.41%
3/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Atypical pneumonia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.41%
3/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Localised infection
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
8/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sialoadenitis
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Wound infection
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.41%
3/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood pressure increased
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.54%
4/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.41%
3/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Migraine
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anger
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Libido decreased
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Renal pain
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.27%
2/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.14%
1/736
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER