acetaminophen and Osteoarthritis, Knee

acetaminophen has been researched along with Osteoarthritis, Knee in 144 studies

Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group.

Osteoarthritis, Knee: Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)

Research

Studies (144)

Authors

Clinical Trials (46)

Trial Overview

Trial Outcomes

Adherence to Study Medication (Assessed in % of Weeks With Perfect Adherence)

"Over the past week, how many days did you use the study drug for your knee pain?~Over the past week, how many days did you use Tylenol or acetaminophen for your knee pain?~Over the past week, how many days did you use other medications that were prescribed by one of your doctors for your knee pain?~Over the past week, how many days did you use other medications, creams or supplements that you got without a prescription for your knee pain?~Over the past week, how many days did you use any medications for a different problem or type of pain (e.g. headache)? Results reported as percentage of study weeks with perfect participant adherence to study medications, with higher percentages indicating higher adherence." (NCT01799213)
Timeframe: Weekly, for duration of observation period (14 weeks)

Adherence to Study Medication (Assessed in Weeks Adherent)

"Over the past week, how many days did you use the study drug for your knee pain?~Over the past week, how many days did you use Tylenol or acetaminophen for your knee pain?~Over the past week, how many days did you use other medications that were prescribed by one of your doctors for your knee pain?~Over the past week, how many days did you use other medications, creams or supplements that you got without a prescription for your knee pain?~Over the past week, how many days did you use any medications for a different problem or type of pain (e.g. headache)? Results reported as percentage of study weeks with perfect participant adherence to study medications, with higher percentages indicating higher adherence." (NCT01799213)
Timeframe: Weekly, for duration of observation period (14 weeks)

Area Under the Curve (AUC) of the WOMAC Pain Scale Score Over 14 Weeks

The AUC is a commonly used measure that combines multiple measurements over a specific time interval into a single index. The AUC provides a single score that quantifies each participant's total WOMAC score across the repeated measurements. The AUC is valid regardless of increases or decreases in reported pain over time. In this case, the possible range is 0-20, with higher scores indicating worse pain. (NCT01799213)
Timeframe: 14 Weeks

Global Impression of Change

A balanced 5-point scale (rated 1 = Much better to 5 = Much worse) asking subjects to rate their change (if any) in pain since starting the study. The possible range of scores is 1 to 5. (NCT01799213)
Timeframe: 14 weeks

Lower Extremity Disability

Lower extremity disability: Lower extremity functional outcomes will be measured using the WOMAC disability scale. The physical disability scale contains 17 items that assess the amount of difficulty subjects say they have with climbing stairs, rising from a chair, walking, and other activities of daily living. Responses are measured and scored in the same way as the pain scale. The WOMAC lower extremity disability score has a possible score range of 0-68 and higher scores indicate worse functional limitation. (NCT01799213)
Timeframe: 14 weeks

Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks

The WOMAC pain score has a possible score range of 0-20 for Pain and higher scores indicate worse pain. The WOMAC pain scale consists of 5 questions that ask about pain during walking, stair use, lying in bed at night, sitting, and standing. Each question is scored on a 5-point scale, where 0 = None, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain, and 4 = Very severe pain. Total pain scores range from 0 to 20 with higher scores reflecting worse pain. The WOMAC also includes a lower extremity disability scale. Both the pain scale and disability scale (17 items) can be analyzed separately. (NCT01799213)
Timeframe: 4 Weeks

Brief Pain Inventory Interference Scale

Measure of pain-related functional interference (range 0-10; higher score is worse) (NCT01583985)
Timeframe: 3 months, 6 months, 9 months, and 12 months

Brief Pain Inventory Severity Scale

Measure of pain intensity (range 0-10; higher score is worse) (NCT01583985)
Timeframe: 3 months, 6 months, 9 months, and 12 months

Medication-related Symptom Checklist

Checklist of bothersome medication-related symptoms (0-19, higher number = more symptoms) (NCT01583985)
Timeframe: 3 months, 6 months, 9 months, and 12 months

Development of Chronic Opioid Use

Feasibility of collecting data on the percentage of patients who develop chronic opioid use. This is measured as the number of patients who received an opioid prescription per the Arkansas prescription drug monitoring database during the 90-150 day period post operatively. (NCT03986866)
Timeframe: 90-150 days

Knowledge of Post Operative Opioids

Knowledge of Post operative Opioids after surgery via 7 day post operative phone call. Knowledge is measured on a scale of 1 to 10 with 10 being complete knowledge and 1 being no knowledge. (NCT03986866)
Timeframe: 7 days

Number of Patients Who Discontinued Opioids by 3 Months

Post-operative pain control as determined by opioid utilization at three months. This is the number of patients that have discontinued opioids at the 3 month mark. (NCT03986866)
Timeframe: Up to 3 months

Number of Total Days to Opioid Cessation

Feasibility of collecting data on the number of days until opioid cessation (NCT03986866)
Timeframe: Up to 3 months

Change From Baseline in 20-meter Walk

(NCT01535001)
Timeframe: Primary: 12months.

Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)

"The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).~Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority." (NCT01535001)
Timeframe: Primary: 12months.

Change From Baseline in Time From the Timed Up and Go

(NCT01535001)
Timeframe: Primary: 12 months.

Number of Serious Adverse Events Reported at Index Knee

Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants. (NCT01535001)
Timeframe: Primary: 12months.

Weight Change in kg From Baseline

Weight change in kg measured without shoes at the same time of day and on the same scale (NCT01535001)
Timeframe: Primary: 12months.

Change From Baseline in EQ-5D

"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under Links).~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)." (NCT01535001)
Timeframe: Primary: 12months.

Change in the Five KOOS Subscale Scores From Baseline

Range of all subscales are 0 to 100 (worst to best). (NCT01535001)
Timeframe: Primary: 12 months.

Proportion of Users of Pain Medication

With possible answers being yes and no (NCT01535001)
Timeframe: Baseline and 12months.

Paracetamol Intake

Paracetamol intake (500 mg), number of tablets per month. (NCT01342458)
Timeframe: 6 month

First Peak of the Knee Adduction Moment (KAM) During Gait.

The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure. (NCT01342458)
Timeframe: 6 month

Global Score of the Lequesne´s Questionaire Algo-functional.

This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively. (NCT01342458)
Timeframe: 6 month

Six-minute Walk Test

The six-minute walk test assesses distance in meters walked over 6 minutes. (NCT01342458)
Timeframe: 6 month

Western Ontario and McMaster Universities (WOMAC) Pain Subscale

The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain. (NCT01342458)
Timeframe: 6 month

WOMAC Physical Function Subscale

The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations. (NCT01342458)
Timeframe: 6 month

WOMAC Stiffness Subscale

The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function. (NCT01342458)
Timeframe: 6 month

WOMAC Total Score

The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition. (NCT01342458)
Timeframe: 6 month

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.

"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.

"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.

"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.

"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 12/Early Termination

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.

"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 2

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 2

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 2

Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.

"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 2

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.

"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 6

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 6

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 6

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.

"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline." (NCT01787188)
Timeframe: Baseline to Week 6

Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 1

Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 3

Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 1

Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 3

Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks

"Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.~Change from baseline was average of post-dose PIs minus average of pre-dose PI." (NCT00565084)
Timeframe: All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)

Average Daily Pain Scores - BS11 Pain Scores.

The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain. (NCT00324038)
Timeframe: every day over a 12 week study duration.

The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.

ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40. (NCT00743093)
Timeframe: serial samples for 16-40 days

The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).

(NCT00743093)
Timeframe: Days 1-3

Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand

"Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score.~Change calculated as difference between the month 6 value and baseline value~Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand" (NCT00291499)
Timeframe: 6 month

Change in Global Spontaneous Pain Intensity of Target Hand

Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand. (NCT00291499)
Timeframe: 6 months

Change in Grip Strength

"Grip strength determined on both hands using a Jamar dynamometer.Patients were required to grip the dynamometer handle and squeeze as hard as possible according to their individual pain limits. The right hand grip was measured first, then the left; this procedure was performed 3 times. The mean value of these 3 measurements was recorded.~Change calculated as difference between the month 6 value and baseline value" (NCT00291499)
Timeframe: 6 months

Change in Morning Stiffness Duration

Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value (NCT00291499)
Timeframe: 6 months

Consumption of Paracetamol

Total consumption (between ^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary (NCT00291499)
Timeframe: 6 months

Reviews

23 reviews available for acetaminophen and Osteoarthritis, Knee

Trials

68 trials available for acetaminophen and Osteoarthritis, Knee

Other Studies

53 other studies available for acetaminophen and Osteoarthritis, Knee