Chronic PainPhase 3NCT00983073
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic
A Phase 3 study testing Tapentadol in people with Chronic Pain and Osteoarthritis, run by Grünenthal GmbH at 24 sites in 5 countries.
Trial summary
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Pain, Osteoarthritis
- What is being tested?
- Tapentadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 24 sitesin 5 countries
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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.
Trial locations and contacts
24 sites in 5 countries.
24 sites in 5 countries
Germany7 sites
Site 5
Berlin
Site 2
Köln Dünnwald
Site 4
Leipzig
Site 6
Leipzig
Site 1
Marl
Site 3
Meine
Site 8
Rudolstadt
United Kingdom6 sites
Site 3
London
Site 9
London
Site 06
Manchester
Site 08
Portsmouth
Site 1
Solihull
Site 4
Swansea
Spain5 sites
Site 2
A Coruña
Site 7
A Coruña
Site 6
Lugo
Site 3
Madrid
Site 1
Torrelavega
About this study
Official title: An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.
The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.
- Conditions
- Chronic Pain, Osteoarthritis
- Being tested
- Tapentadol
- Keywords
- Osteoarthritis, Pain, Assessment, Tapentadol, Centrally acting analgesic, Chronic pain due to osteoarthritis
- Medical subject headings
- Chronic Pain, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Also called Nucynta, Palexia
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tapentadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of week 6
Secondary outcomes (17)
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".
Measured: Baseline
Change in Average Pain Intensity After 6 Weeks of Tapentadol PR 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". 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.
Measured: Baseline; End of Week 6 (6 Weeks)
Change in Average Pain Intensity After 12 Weeks of Tapentadol PR 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". 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.
Measured: Baseline; End of Week 12 (12 Weeks)
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.
Measured: Baseline; End of Week 6 (6 Weeks)
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.
Measured: Baseline; End of Week 12 (12 Weeks)
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.
Measured: Baseline; End of Week 6 (6 Weeks)
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.
Measured: Baseline, End of Week 12 (12 Weeks)
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.
Measured: Baseline; End of Week 6 (6 Weeks)
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.
Measured: Baseline; End of Week 12 (12 Weeks)
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.
Measured: Baseline; End of Week 6 (6 Weeks)
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.
Measured: Baseline; End of Week 12 (12 Weeks)
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.
Measured: Baseline
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.
Measured: Baseline; End of Week 6 (6 Weeks)
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.
Measured: Baseline; End of Week 12 (12 Weeks)
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.
Measured: Baseline
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.
Measured: Baseline; End of Week 6 (6 Weeks)
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
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.
Measured: Baseline; End of Week 12 (12 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Calvo, Dr. MD, Principal investigator, Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria Santander, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983073
- Sponsor's protocol ID
- 441172
- Other IDs
- 2009-010423-58, 2009
- Status last verified
- Oct 2019
- First submitted
- 21 Sep 2009
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22792000
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Pain Due to Osteoarthritis of the Knee Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.
- ClinicalTrials.gov ID
- NCT00983073
- Acronym / sponsor ID
- 441172
- Conditions
- Chronic Pain, Osteoarthritis
- Keywords
- Osteoarthritis, Pain, Assessment, Tapentadol, Centrally acting analgesic, Chronic pain due to osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Posted 29 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.
The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Experimental | Drug: TapentadolTapentadol 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TapentadolAlso: Nucynta, PalexiaTapentadol 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. | Drug | Tapentadol |
Primary outcome
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.
Time frame: Baseline to end of 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.
17 secondary outcomes
Average Pain Intensity Before the Start of Tapentadol Treatment
Time frame: Baseline
Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment
Time frame: Baseline; End of Week 6 (6 Weeks)
Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment
Time frame: Baseline; End of Week 12 (12 Weeks)
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
Time frame: Baseline; End of Week 6 (6 Weeks)
EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
Time frame: Baseline; End of Week 12 (12 Weeks)
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
Time frame: Baseline; End of Week 6 (6 Weeks)
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
Time frame: Baseline, End of Week 12 (12 Weeks)
Patient Global Impression of Change
Time frame: Baseline; End of Week 6 (6 Weeks)
Patient Global Impression of Change
Time frame: Baseline; End of Week 12 (12 Weeks)
Clinical Global Impression of Change
Time frame: Baseline; End of Week 6 (6 Weeks)
Clinical Global Impression of Change
Time frame: Baseline; End of Week 12 (12 Weeks)
Participant's Satisfaction With Previous Analgesic Treatment
Time frame: Baseline
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Time frame: Baseline; End of Week 6 (6 Weeks)
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Time frame: Baseline; End of Week 12 (12 Weeks)
Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee
Time frame: Baseline
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
Time frame: Baseline; End of Week 6 (6 Weeks)
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
Time frame: Baseline; End of Week 12 (12 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22792000Steigerwald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Calvo, Dr. MD principal investigator
Hospital Universitario Marqués de Valdecilla, Universidad de Cantabria Santander, Spain
24 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tapentadol in people with Chronic Pain and Osteoarthritis, run by Grünenthal GmbH at 24 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, United Kingdom, Spain, France, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline to end of week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00983073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.