Actual Use Trial of Ibuprofen 400 mg

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02294019
• Collaborator: (none)
• Enrollment: 738
• Locations: 25
• Arm: 1
• Duration (Months): 5.9
• Patients Per Site: 29.5
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patient Compliance	Drug: Ibuprofen 400 mg caplet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 738 participants
• Masking: None (Open Label)
• Official Title: A Multicenter Actual Use And Compliance Study Of Ibuprofen 400 Mg In A Simulated Over-the-counter Environment
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibuprofen caplet arm	Drug: Ibuprofen 400 mg caplet; 400 milligram (mg) caplet according to Drug Facts label

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study [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.

Secondary Outcome Measures

1. Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study [Day1 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 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Current government-issued identification (ID)

• Pregnant or breastfeeding females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert's Discount Pharmacy	Hoover	Alabama	United States	35226
2	Pharmacy at the Pig	McCalla	Alabama	United States	35111
3	Community Clinical Pharmacy	Mesa	Arizona	United States	85202
4	Garden Drug	Fort Lauderdale	Florida	United States	33309
5	Pill Box Pharmacy and Medical Supply	Pembroke Pines	Florida	United States	33026
6	Summerfield Pharmacy	Riverview	Florida	United States	33569
7	Sutton Family Pharmacy	Dalton	Georgia	United States	30721
8	Wynn's Pharmacy Inc.	Griffin	Georgia	United States	30224
9	Goodrich Pharmacy	Andover	Minnesota	United States	55304
10	Goodrich Pharmacy	Anoka	Minnesota	United States	55303
11	Goodrich Pharmacy	Blaine	Minnesota	United States	55434
12	Goodrich Pharmacy	Elk River	Minnesota	United States	55330
13	Cub Pharmacy Number 1924	St. Louis Park	Minnesota	United States	55426
14	Albers' Specialty Pharmacy	Kansas City	Missouri	United States	64111
15	Countryside Pharmacy	Savannah	Missouri	United States	64485
16	Texas Road Pharmacy	Monroe	New Jersey	United States	08831
17	Phil's Pills, Inc.	Albuquerque	New Mexico	United States	87110
18	Total Health and Wellness Center of Taos	Taos	New Mexico	United States	87571
19	Kroger Pharmacy #342	Cary	North Carolina	United States	27513
20	Family Prescription Center	Bethlehem	Pennsylvania	United States	18015
21	The Medicine Shoppe	Bountiful	Utah	United States	84010
22	Northview Pharmacy	Layton	Utah	United States	84041
23	Family Plaza Pharmacy	West Jordan	Utah	United States	84088
24	Foothills Compounding Pharmacy	Enumclaw	Washington	United States	98022
25	Ostrom Drugs	Kenmore	Washington	United States	98028

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02294019
• Other Study ID Numbers: B3491013; AUT
• First Posted: Nov 19, 2014
• Last Update Posted: May 30, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Pfizer: ibuprofen 400 mg; actual use; compliance
• Additional relevant MeSH terms: Ibuprofen

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Ibuprofen
Arm/Group Description	All participants who purchased at least 1 carton of study medication.
Period Title: Overall Study
STARTED	738
COMPLETED	635
NOT COMPLETED	103

Baseline Characteristics

Arm/Group Title	Ibuprofen
Arm/Group Description	All participants who purchased at least 1 carton of study medication.
Overall Participants	738
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.5 (13.7)
Sex: Female, Male (Count of Participants)
Female	412 55.8%
Male	326 44.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study
Description	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.
Time Frame	Day 1 up to 30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ibuprofen
Arm/Group Description	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.
Measure Participants	685
Number (95% Confidence Interval) [percentage of participants]	95.2 12.9%

2. Secondary Outcome

Title	Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study
Description	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.
Time Frame	Day1 up to 30 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Ibuprofen
Arm/Group Description	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.
Measure Participants	685
Number (95% Confidence Interval) [percentage of participants]	84.4 11.4%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Ibuprofen (Safety Population)
Arm/Group Description	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
All Cause Mortality
	Ibuprofen (Safety Population)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ibuprofen (Safety Population)
	Affected / at Risk (%)	# Events
Total	6/736 (0.8%)
Cardiac disorders
Coronary artery occlusion	1/736 (0.1%)
Infections and infestations
Atypical pneumonia	1/736 (0.1%)
Cellulitis	1/736 (0.1%)
Pneumonia	1/736 (0.1%)
Injury, poisoning and procedural complications
Joint dislocation	1/736 (0.1%)
Renal and urinary disorders
Nephrolithiasis	1/736 (0.1%)
Other (Not Including Serious) Adverse Events
	Ibuprofen (Safety Population)
	Affected / at Risk (%)	# Events
Total	76/736 (10.3%)
Cardiac disorders
Palpitations	1/736 (0.1%)
Ear and labyrinth disorders
Tinnitus	1/736 (0.1%)
Eye disorders
Eye irritation	1/736 (0.1%)
Gastrointestinal disorders
Abdominal discomfort	2/736 (0.3%)
Abdominal pain upper	1/736 (0.1%)
Aphthous stomatitis	1/736 (0.1%)
Constipation	3/736 (0.4%)
Diarrhoea	2/736 (0.3%)
Dyspepsia	1/736 (0.1%)
Flatulence	1/736 (0.1%)
Gastrooesophageal reflux disease	4/736 (0.5%)
Haematochezia	1/736 (0.1%)
Nausea	3/736 (0.4%)
Pancreatitis acute	1/736 (0.1%)
Toothache	2/736 (0.3%)
General disorders
Peripheral swelling	1/736 (0.1%)
Infections and infestations
Atypical pneumonia	1/736 (0.1%)
Bronchitis	2/736 (0.3%)
Influenza	3/736 (0.4%)
Localised infection	2/736 (0.3%)
Nasopharyngitis	8/736 (1.1%)
Pharyngitis streptococcal	2/736 (0.3%)
Respiratory tract infection	1/736 (0.1%)
Sialoadenitis	1/736 (0.1%)
Sinusitis	2/736 (0.3%)
Wound infection	1/736 (0.1%)
Injury, poisoning and procedural complications
Animal bite	1/736 (0.1%)
Arthropod bite	1/736 (0.1%)
Eye injury	1/736 (0.1%)
Laceration	3/736 (0.4%)
Ligament sprain	2/736 (0.3%)
Limb traumatic amputation	1/736 (0.1%)
Procedural pain	1/736 (0.1%)
Investigations
Blood pressure increased	1/736 (0.1%)
Metabolism and nutrition disorders
Dehydration	1/736 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/736 (0.1%)
Back pain	2/736 (0.3%)
Muscle spasms	1/736 (0.1%)
Myalgia	1/736 (0.1%)
Neck pain	2/736 (0.3%)
Nervous system disorders
Dizziness	4/736 (0.5%)
Headache	3/736 (0.4%)
Migraine	2/736 (0.3%)
Tremor	1/736 (0.1%)
Psychiatric disorders
Anger	1/736 (0.1%)
Anxiety	2/736 (0.3%)
Libido decreased	1/736 (0.1%)
Renal and urinary disorders
Renal pain	1/736 (0.1%)
Respiratory, thoracic and mediastinal disorders
Cough	1/736 (0.1%)
Oropharyngeal pain	1/736 (0.1%)
Skin and subcutaneous tissue disorders
Pruritus	2/736 (0.3%)
Urticaria	1/736 (0.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.