Actual Use Trial of Naproxen Sodium | NCT01427803

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: Naproxen Sodium ER (BAYH6689)

Name	Type	Description	Arm Group Labels	Other Names
Naproxen Sodium ER (BAYH6689)	Drug	BAYH6689; oral tablet used as needed upon incidence of pain	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimated Percentage of Misuse for Non-Therapeutic Reasons	The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.	28 days

Secondary Outcomes

Measure	Description	Time Frame
Non-therapeutic Reasons for Misuse	Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.	28 days
Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Patterns of Use Cohort	A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
FG001	Reasons for Misuse Cohort

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Patterns of Use User Population	A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
BG001	Reasons for Misuse Interviewed Population	A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
	OG0006.5

Secondary

Non-therapeutic Reasons for Misuse

Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.

Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis

Posted

Number

Participants

28 days

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course

This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day". A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."

Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population

Posted

Number

Percentage of participants

28 days

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days

Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.

Participants in Patterns of Use User Population who had at least 10 use days of the product

Posted

Number

Percentage of participants

28 days

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day

Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.

Participants in Patterns of Use User Population who had at least 10 use days of the product

Posted

Number

Percentage of participants

28 days

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken

Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.

Participants in Patterns of Use cohort who took the product

Posted

Number

Percentage of participants

28 days

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Percentage of Dosing Occasions Where More Than One Tablet Was Taken

Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.

Participants in Patterns of Use cohort who took the product

Posted

Number

Percentage of dosing occasions

28 days

Dosing occasions

Participants

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose

Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.

Participants in Patterns of Use cohort who took the product

Posted

Number

Percentage of participants

28 days

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Secondary

Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose

Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection

Participants in Patterns of Use cohort who took the product

Posted

Number

Percentage of dosing occasions

28 days

Dosing occasions

Participants

ID	Title	Description
OG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Naproxen Sodium ER (BAYH6689)	Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.			6	745	89	745

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
overdose	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 events1 affected745 at risk
cardiac failure congestive	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 events1 affected745 at risk
diarrhea haemorrhagic	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 events1 affected745 at risk
viral infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 events1 affected745 at risk
gallbladder disorder	Hepatobiliary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 events1 affected745 at risk
hypersensitivity	Immune system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 events1 affected745 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
abdominal pain upper	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG00015 events14 affected745 at risk
constipation	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG00012 events12 affected745 at risk
diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG00011 events11 affected745 at risk
nasopharyngitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00020 events20 affected745 at risk
headache	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG00015 events14 affected745 at risk
sinusitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00010 events10 affected745 at risk
back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0008 events8 affected745 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Hoover	Alabama	35226	United States

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms