OsteoarthitisPhase 2NCT00745069
Efficacy and Safety of Tapentadol Extended Release Tablets in the Treatment of Moderate to Severe Pain in Subjects With Knee Osteoarthritis
A Phase 2 study testing tapentadol HCl in people with Osteoarthitis and Chronic Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study was to examine a low and high dose of tapentadol extended release tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to severe pain due to osteoarthritis of the knee during a 4-week period. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthitis, Chronic Pain, Knee Pain
- What is being tested?
- tapentadol HCl
- How many people
- 670 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months
- Moderate to severe chronic pain due to knee osteoarithritis
Who cannot join
- Previously opioid treated subject who had a history of withdrawal after cessation of the opioid
- History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate
- Subjects with history of uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg)
- Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit
About this study
Official title: 4-Week Randomized Multicenter DB, Placebo- and Active-controlled, Parallel-group, Forced-titration Phase 2B Study of Efficacy and Safety With CG5503 Prolonged Release (PR) to 233 mg BID and Oxycodone PR to 20 mg BID vs Placebo in Subjects With Moderate to Severe Chronic Pain of Knee Osteoarthritis
The purpose of this study was to examine a low and high dose of tapentadol extended release tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum concentrations and safety of tapentadol and oxycodone were also examined.
Read the detailed description
Arthritis is the most common chronic debilitating disease in the United States (more than 43 million people or 1 in 6). Osteoarthritis of the knee is a very common and a major cause of disability. Pharmacological treatment includes the following analgesics: non-steroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase II (COX-II) inhibitors, acetaminophen and opioids. Despite the numerous available analgesic medications, 60% to 80% of patients suffering from chronic pain are currently treated inadequately. Opioid analgesics have been shown to be efficacious in chronic non-malignant pain and can be an important therapeutic asset. The study was a 4-week randomized multicenter double-blind, placebo- and active-controlled, parallel-group, forced-titration phase 2B study of efficacy and safety with tapentadol extended release (ER) to 233 mg BID and oxycodone PR to 20 mg BID vs placebo in subjects with moderate to severe chronic pain of knee osteoarthritis. Primary efficacy outcome was the average pain intensity 24 hours before the last evaluation time or 29 days. Safety was evaluated by reporting of adverse events, laboratory tests, vital sign measures, ECGs. This study hypothesis was that tapentadol extended release was effective in relieving chronic moderate to severe pain from knee osteoarthritis compared to treatment with placebo using 2 dosing regimens for tapentadol.
tapentadol extended release white, fim-coated tablet taken orally twice a day during a 4-week period at a dose that steadily increased up to 100 mg or 200 mg; placebo tablets; or oxycodone extended release tablet, 20 mg.
- Conditions
- Osteoarthitis, Chronic Pain, Knee Pain
- Being tested
- tapentadol HCl
- Keywords
- Tapentadol, Osteoarthritis, Analgesia, Chronic pain
- Medical subject headings
- Chronic Pain, Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tapentadol HClDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.
Secondary outcomes (1)
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the last timepoint or 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startJul 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745069
- Sponsor's protocol ID
- CR004183
- Status last verified
- Apr 2010
- First submitted
- 29 Aug 2008
- Last updated
- 18 May 2011
- Results posted
- No
Publications
Eichenbaum G, Gohler K, Etropolski M, Steigerwald I, Pergolizzi J, Kim M, Vorsanger G. Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency. J Opioid Manag. 2015 May-Jun;11(3):211-27. doi: 10.5055/jom.2015.0270.
PubMed 25985806
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-Week Randomized Multicenter DB, Placebo- and Active-controlled, Parallel-group, Forced-titration Phase 2B Study of Efficacy and Safety With CG5503 Prolonged Release (PR) to 233 mg BID and Oxycodone PR to 20 mg BID vs Placebo in Subjects With Moderate to Severe Chronic Pain of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00745069
- Acronym / sponsor ID
- CR004183
- Conditions
- Osteoarthitis, Chronic Pain, Knee Pain
- Keywords
- Tapentadol, Osteoarthritis, Analgesia, Chronic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Jul 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to examine a low and high dose of tapentadol extended release tablet taken orally twice a day to reduce pain in subjects suffering from chronic moderate to severe pain due to osteoarthritis of the knee during a 4-week period. Subjects steadily increased their dose up to the low (100 mg) or high (200 mg) dose. Pain relief was compared to subjects taking placebo tablets or oxycodone extended release tablet, 20 mg. The serum concentrations and safety of tapentadol and oxycodone were also examined.
Detailed description
Arthritis is the most common chronic debilitating disease in the United States (more than 43 million people or 1 in 6). Osteoarthritis of the knee is a very common and a major cause of disability. Pharmacological treatment includes the following analgesics: non-steroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase II (COX-II) inhibitors, acetaminophen and opioids. Despite the numerous available analgesic medications, 60% to 80% of patients suffering from chronic pain are currently treated inadequately. Opioid analgesics have been shown to be efficacious in chronic non-malignant pain and can be an important therapeutic asset. The study was a 4-week randomized multicenter double-blind, placebo- and active-controlled, parallel-group, forced-titration phase 2B study of efficacy and safety with tapentadol extended release (ER) to 233 mg BID and oxycodone PR to 20 mg BID vs placebo in subjects with moderate to severe chronic pain of knee osteoarthritis. Primary efficacy outcome was the average pain intensity 24 hours before the last evaluation time or 29 days. Safety was evaluated by reporting of adverse events, laboratory tests, vital sign measures, ECGs. This study hypothesis was that tapentadol extended release was effective in relieving chronic moderate to severe pain from knee osteoarthritis compared to treatment with placebo using 2 dosing regimens for tapentadol.
tapentadol extended release white, fim-coated tablet taken orally twice a day during a 4-week period at a dose that steadily increased up to 100 mg or 200 mg; placebo tablets; or oxycodone extended release tablet, 20 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with a clinical diagnosis of osteoarthritis of the knee based symptoms and/or radiographic criteria present for at least 3 months
- Moderate to severe chronic pain due to knee osteoarithritis
Key exclusion criteria (4 listed)
- Previously opioid treated subject who had a history of withdrawal after cessation of the opioid
- History of seizure disorder, psychiatric disease and history of head trauma requiring evaluation by hospital based staff, or unconsciousness of unknown origin. Subjects who, in the investigator's judgment, have well-controlled depression or anxiety disorder may participate
- Subjects with history of uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg)
- Intake of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, barbiturates, neuroleptics, monoamine oxidase inhibitors, and antiparkinsonian drugs within the 30 days prior to the screening visit
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 |
|---|---|---|
| tapentadol HCl | Drug | – |
Primary outcome
Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.
1 secondary outcome
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at the last timepoint or 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Derived from this study: PubMed 25985806Eichenbaum G, Gohler K, Etropolski M, Steigerwald I, Pergolizzi J, Kim M, Vorsanger G. Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency. J Opioid Manag. 2015 May-Jun;11(3):211-27. doi: 10.5055/jom.2015.0270.
- Efficacy and safety of tapentadol extended release tablets in the treatment of moderate to severe pain in subjects with knee osteoarthritisLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tapentadol HCl in people with Osteoarthitis and Chronic Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 2 inclusion and 4 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 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average pain intensity over the preceding 24 hours evaluated at the last timepoint or 29 days using a visual scale.. 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 NCT00745069, 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 18 May 2011.