Evaluation of Effectiveness and Tolerability of Tapentado... | NCT00983073

ID	Type	Description	Link
2009-010423-58	EudraCT Number

Label	Type	Description	Intervention Names
Tapentadol	Experimental	Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol IR tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.	Drug: Tapentadol

Name	Type	Description	Arm Group Labels	Other Names
Tapentadol	Drug	Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 500 mg of Tapentadol per day. Maintenance Period: Participants continuing on the dose established in the previous period.

Measure	Description	Time Frame
The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.	For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.	Baseline to end of week 6

Measure	Description	Time Frame
Average Pain Intensity Before the Start of Tapentadol Treatment	For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS)where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".	Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants have signed an Informed Consent Form indicating that they understand the purpose of and the procedures required for the trial and are willing to participate in it.
Participants are men or non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women of childbearing potential must have a negative pregnancy test at screening.
Participants must be appropriately communicative to verbalize and to differentiate with regard to location and intensity of the pain.
Participants must be at least 40 years of age.
Participants must have a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology (ACR) classification criteria:
- Knee pain and
- Radiographic osteophytes or
- Knee pain and
- Aged 40 years or above, and
- Morning stiffness of less than 30 minutes of duration and
- Crepitus on motion.
Participants must have pain at the reference joint which has been present for at least 3 months.
Participant's pain must require a strong analgesic (defined as WHO Step III) as judged by the Investigator.
Participants must report a rate of satisfaction with their previous analgesic regimen not exceeding "fair" on a participant satisfaction with treatment scale (5-point VRS).
If under regular, daily pretreatment:
- Participants must be taking a WHO Step I or Step II analgesic medication for osteoarthritis of the knee on a daily basis for at least 2 weeks prior to the Screening Visit.
- The Investigator considers dose increase of WHO Step I analgesics (as mono- or combination therapy) and/or continuation with or dose increase of WHO Step II analgesics inadequate for the individual participant, whatever applicable.
- Participants must have an average pain intensity score (NRS 3) greater than 5 points during the last 3 days prior to the Screening Visit.

OR if no regular analgesic pretreatment is reported:

Participants must have an average pain intensity score (NRS-3)greater than 6 points in the last 3 days prior to the Screening Visit and related to osteoarthritis.

Exclusion Criteria:

Presence of a clinically significant disease or laboratory findings that in the Investigator's opinion may affect efficacy or safety assessments.
Presence of active systemic or local infection, that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments.
History of alcohol or drug abuse, or suspicion thereof in the Investigator's judgment.
Presence of concomitant autoimmune inflammatory conditions.
Known history of or laboratory values reflecting severe renal impairment.
Known history of moderately or severely impaired hepatic function.
History of or active hepatitis B or C within the past 3 months or history of HIV infection.
History of seizure disorder or epilepsy.
Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness.
Pregnant or breast-feeding.
History of allergy to, or hypersensitivity to tapentadol hydrochloride or its excipients, or contraindications related to tapentadol hydrochloride including:
- Participants with acute or severe bronchial asthma or hypercapnia.
- Participants who have or are suspected of having paralytic ileus.
Employees of the Investigator or trial site, with direct involvement in this trial or other trials under the direction of the Investigator or trial site, as well as family members of employees of the Investigator.
Participation in another trial concurrently or within 4 weeks prior to the Screening Visit.
Known to or suspected of not being able to comply with the protocol and the use of the investigational medicinal product.
Use of monoamine oxidase inhibitors within 14 days before the Screening Visit.
Non-stable dosing of selective serotonin reuptake inhibitors within 30 days before the Screening Visit (Doses must remain stable during the trial).
Osteoarthritis in a flare state.
Use of intra-articular injections of hyaluronic acid in the reference joint within 3 months before the Screening Visit.
Presence of conditions other than osteoarthritis of the reference joint that could confound the assessment or self-evaluation of pain, e.g., anatomical deformities, significant skin conditions such as abscess or syndromes with widespread pain such as fibromyalgia. Participants with osteoarthritis at joints other than the reference joint will not be excluded as long as the reference joint is the source of main pain and disability.
History and clinical signs at the reference joint of crystal-induced (e.g., gout, pseudo-gout), metabolic, infectious and autoimmune disease.
Any concomitant painful condition that could interfere with the participants' trial assessments or with their ability to differentiate the current joint pain from other painful conditions.
Any painful procedures during the trial (e.g., major surgery, including the reference joint) that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
Pending litigation due to chronic pain or disability.
Intake of Step III analgesics within the 30 days prior to the Screening Visit.

Name	Affiliation	Role
Jaime Calvo, Dr. MD	Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria Santander, Spain	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
22792000	Result	Steigerwald I, Muller M, Kujawa J, Balblanc JC, Calvo-Alen J. Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, phase 3b study. J Pain Res. 2012;5:121-38. doi: 10.2147/JPR.S30540. Epub 2012 Jun 15.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.

For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.

All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).

Posted

Mean

Standard Deviation

Units on a scale

Baseline to end of week 6

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000193

Title

Denominators

Categories

Title	Measurements
	OG000-3.4± 2.10

Secondary

Average Pain Intensity Before the Start of Tapentadol Treatment

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment

Number of participants with data available.

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants

Secondary

Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment

Number of participants with data available.

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants

Secondary

EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time

The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.

Number of participants with data available.

Posted

Mean

Standard Deviation

Units on a scale

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts

Secondary

EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time

Number of participants with data available

Posted

Mean

Standard Deviation

Units on a scale

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts

Secondary

Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)

EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.

Number of participants with data available.

Posted

Mean

Standard Deviation

Units on a scale

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts

Secondary

Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)

Number of participants with data available

Posted

Mean

Standard Deviation

Units on a scale

Baseline, End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts

Secondary

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.

Number of participants with data available

Posted

Number

Participants

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Patient Global Impression of Change

Number of participants with data available

Posted

Number

Participants

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Clinical Global Impression of Change

In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.

Number of participants with data available

Posted

Number

Participants

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Clinical Global Impression of Change

Number of participants with data available

Posted

Number

Participants

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Participant's Satisfaction With Previous Analgesic Treatment

Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.

Number of participants with data available.

Posted

Number

participants

Baseline

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.

Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.

Number of participants with data available

Posted

Number

participants

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with either 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.

Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.

Number of participants with data available

Posted

Number

participants

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts
Participants	OG000

Secondary

Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee

Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.

Number of participants with data available

Posted

Mean

Standard Deviation

units on a scale

Baseline

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Secondary

Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6

The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.

Number of participants with data available

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 6 (6 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts

Secondary

Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12

Number of participants with data available

Posted

Mean

Standard Deviation

units on a scale

Baseline; End of Week 12 (12 Weeks)

ID	Title	Description
OG000	Tapentadol PR	All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.

Units	Counts

Facility	Status	City	State	ZIP	Country	Contacts
Site 1		Belfort			France
Site 4

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Myocardial infarction	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Cellulitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Urinary tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Facial palsy	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Panic attack	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected200 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00021 affected200 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00011 affected200 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00020 affected200 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00026 affected200 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG00010 affected200 at risk
Fatigue	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG00021 affected200 at risk
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG00016 affected200 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG00024 affected200 at risk
Headache	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG00013 affected200 at risk
Somnolence	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG00014 affected200 at risk

ID	Term
D059350	Chronic Pain
D010003	Osteoarthritis
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals