Trial Outcomes & Findings for Naproxen Sodium Extended-Release Actual Use Study (NCT NCT00751400)
NCT ID: NCT00751400
Last Updated: 2015-08-25
Results Overview
Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
COMPLETED
PHASE3
497 participants
1 month
2015-08-25
Participant Flow
Recruitment for the study was conducted using newspaper ads, direct mailing, in-store pharmacy posters, and flyers. Potential subjects who learned about the study through local advertising were directed to call a toll-free number (call center at the CRO (Contract Research Organization)) where minimal screening questions were asked.
Once at the pharmacy, if the screening criteria were met, subjects were given an (empty) OTC (Over The Counter) package and were allowed as much time as needed to review the label. They were then told the cost of the investigational product and asked if they would like to purchase it for their own use.
Participant milestones
| Measure |
Naproxen Sodium ER (BAYH6689)
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Overall Study
STARTED
|
497
|
|
Overall Study
Subjects Provided Drug
|
497
|
|
Overall Study
Subjects Consumed Drug
|
485
|
|
Overall Study
Subjects Provided Detailed Use Data
|
467
|
|
Overall Study
COMPLETED
|
487
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Naproxen Sodium ER (BAYH6689)
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
Baseline Characteristics
Naproxen Sodium Extended-Release Actual Use Study
Baseline characteristics by cohort
| Measure |
Naproxen Sodium ER (BAYH6689)
n=497 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 15.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
292 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=93 Participants
|
|
Education
8th grade or less
|
6 participants
n=93 Participants
|
|
Education
Some high school
|
21 participants
n=93 Participants
|
|
Education
High school graduate, GED, or certificate
|
119 participants
n=93 Participants
|
|
Education
Some college or technical school
|
185 participants
n=93 Participants
|
|
Education
College graduate
|
117 participants
n=93 Participants
|
|
Education
Post-graduate degree
|
49 participants
n=93 Participants
|
|
Education
Missing
|
0 participants
n=93 Participants
|
|
Literacy
Normal
|
437 participants
n=93 Participants
|
|
Literacy
Low
|
56 participants
n=93 Participants
|
|
Literacy
No REALM Score
|
4 participants
n=93 Participants
|
|
Prior Analgesic Use
Heavy
|
148 participants
n=93 Participants
|
|
Prior Analgesic Use
Regular
|
349 participants
n=93 Participants
|
|
Race
White
|
399 participants
n=93 Participants
|
|
Race
Black
|
56 participants
n=93 Participants
|
|
Race
Hispanic
|
3 participants
n=93 Participants
|
|
Race
Asian
|
8 participants
n=93 Participants
|
|
Race
Other
|
31 participants
n=93 Participants
|
|
Race
Missing
|
0 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Use Days With One or More Misuse Occasions
use days without a misuse occasion
|
2112 days
|
|
Use Days With One or More Misuse Occasions
use days with a misuse occasion
|
294 days
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Dosing Occasions With One and More Than One Tablet Taken
only one tablet taken
|
2500 dosing occasions
|
|
Dosing Occasions With One and More Than One Tablet Taken
more than one tablet taken
|
66 dosing occasions
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Use Days With and Without Next Dose Less Than 22 Hours Later
no dose less than 22 hours later
|
2175 days
|
|
Use Days With and Without Next Dose Less Than 22 Hours Later
at least one dose less than 22 hours later
|
231 days
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Number of Subjects With and Without More Than One Tablet Taken Per Dose
never took more than one tablet per dose
|
440 participants
|
|
Number of Subjects With and Without More Than One Tablet Taken Per Dose
took more than one tablet per dose
|
27 participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Number of Subjects With and Without Next Dose Less Than 22 Hours Later
no doses less than 22 hours later
|
359 participants
|
|
Number of Subjects With and Without Next Dose Less Than 22 Hours Later
at least one dose less than 22 hours later
|
108 participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion).
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Number of Subjects With and Without More Than 660 mg at Least Once
not more than 660 mg
|
344 participants
|
|
Number of Subjects With and Without More Than 660 mg at Least Once
more than 660 mg at least once
|
123 participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Average Daily Dose
|
722 mg
Standard Deviation 233.4
|
SECONDARY outcome
Timeframe: 1 monthPopulation: number of subjects reporting at least one tablet taken at any point during study
This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=485 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days
not more than 10 consecutive days
|
376 participants
|
|
Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days
more than 10 consecutive days
|
109 participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Number of Total Dosing Occasions Per Subject
|
5.5 dosing occasions
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Number of subjects reflects subjects that completed at least one interview and provided use information for the previous 5 days
Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion.
Outcome measures
| Measure |
Naproxen Sodium ER (BAYH6689)
n=467 Participants
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Number of Dosing Occasions Per Subject That Exceeded 660 mg
|
0.6 dosing occasions
Standard Deviation 1.6
|
Adverse Events
Naproxen Sodium ER (BAYH6689)
Serious adverse events
| Measure |
Naproxen Sodium ER (BAYH6689)
n=485 participants at risk
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.21%
1/485 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.21%
1/485 • Number of events 1
|
Other adverse events
| Measure |
Naproxen Sodium ER (BAYH6689)
n=485 participants at risk
subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.41%
2/485 • Number of events 2
|
|
Eye disorders
Eye disorder
|
0.21%
1/485 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.41%
2/485 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
7/485 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
1.2%
6/485 • Number of events 6
|
|
Gastrointestinal disorders
Dental discomfort
|
0.21%
1/485 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
7/485 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
10/485 • Number of events 12
|
|
Gastrointestinal disorders
Flatulence
|
0.82%
4/485 • Number of events 4
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.21%
1/485 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.6%
8/485 • Number of events 8
|
|
Gastrointestinal disorders
Oesophagitis
|
0.21%
1/485 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.41%
2/485 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
0.41%
2/485 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.41%
2/485 • Number of events 2
|
|
General disorders
Chest pain
|
0.41%
2/485 • Number of events 2
|
|
General disorders
Fatigue
|
0.21%
1/485 • Number of events 1
|
|
General disorders
Irritability
|
0.21%
1/485 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.21%
1/485 • Number of events 1
|
|
General disorders
Sluggishness
|
0.21%
1/485 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.21%
1/485 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.41%
2/485 • Number of events 2
|
|
Infections and infestations
Abdominal abscess
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Gastrointestinal infection
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.41%
2/485 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
0.82%
4/485 • Number of events 4
|
|
Infections and infestations
Oral herpes
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.21%
1/485 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.62%
3/485 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
0.82%
4/485 • Number of events 4
|
|
Infections and infestations
Urinary tract infection
|
0.41%
2/485 • Number of events 2
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.41%
2/485 • Number of events 3
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.41%
2/485 • Number of events 2
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.21%
1/485 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.21%
1/485 • Number of events 1
|
|
Investigations
Blood iron decreased
|
0.21%
1/485 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.41%
2/485 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
5/485 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.82%
4/485 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.21%
1/485 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.21%
1/485 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.41%
2/485 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
6/485 • Number of events 6
|
|
Nervous system disorders
Dizziness
|
0.41%
2/485 • Number of events 3
|
|
Nervous system disorders
Headache
|
2.1%
10/485 • Number of events 10
|
|
Nervous system disorders
Migraine
|
0.41%
2/485 • Number of events 3
|
|
Nervous system disorders
Syncope
|
0.21%
1/485 • Number of events 1
|
|
Psychiatric disorders
Abnormal dreams
|
0.21%
1/485 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.62%
3/485 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.21%
1/485 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.41%
2/485 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.41%
2/485 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.21%
1/485 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.21%
1/485 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.21%
1/485 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.21%
1/485 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.41%
2/485 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
1/485 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.21%
1/485 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60