OsteoarthritisPhase 3NCT00361582
A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement Surgery
A Phase 3 study testing CG5503 IR; tapentadol in people with Osteoarthritis and Pain Assessment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to assess the safety and tolerability of multiple… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Pain Assessment, Arthralgia
- What is being tested?
- CG5503 IR; tapentadol
- How many people
- 669 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Aug 2007
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic osteoarthritis of the hip or the knee based on clinical and radiographic (X-Ray) criteria defined by standard accepted guidelines
- candidate (qualifies) for primary one-sided total or partial joint replacement surgery due to noninflammatory, end-stage degenerative joint disease (arthritis)
- requires daily doses of analgesic medication for chronic pain.
Who cannot join
- History of seizure disorder or epilepsy suggested by the presence of any of the following
- History of chronic hepatitis B and C or human immunodeficiency virus, or presence of active hepatitis B and C within the past 3 months before screening
- currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressant, neuroleptics, or serotonin norepinephrine reuptake inhibitors.
About this study
Official title: A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease
The purpose of this study is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR patients.
Read the detailed description
CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study was designed to assess the safety and tolerability of CG5503 IR in patients who need joint replacement of the hip or knee due to chronic osteoarthritis. This is a double-blind study, i.e., neither patients nor investigators will know what treatment is given. Before the start of the 10 day double-blind phase, each patient will be screened for eligibility and eligible patients will be randomly assigned to receive either CG5503 IR, oxycodone IR, or placebo (i.e., no active drug). All patients will take their treatment by mouth every 4 to 6 hours during waking hours. A total of 60 doses (up to 6 doses per day) of study treatment will be provided for each patient during the 10-day treatment phase. The study treatment will be dispensed on Day 1, and patients will take the first dose in the evening of the same day. The effectiveness of study treatment (CG5503 IR, oxycodone, or placebo) will be assessed using several measures, including 11 Point Pain Numerical Rating Scale, 5-Point Relief Numerical Rating Scale, and Patient Global Impression of Change. Using these scales, patients will indicate their pain intensity level, pain relief level, and overall status of their well-being. Safety and tolerability will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead ECG results. The null hypothesis for the study is that all CG5503 IR dosage efficacy results are equal to placebo based on the 5-day SPID in the treatment of chronic pain caused by osteoarthritis. The alternative study hypothesis is that at least 1 CG5503 IR dose effect will be different from placebo effect. CG5503 IR 50 mg, 75 mg of the base, 10 mg oxycodone or placebo for 10 days taken by mouth every 4 to 6 hours during waking hours. Patients randomized to CG5503 IR 75 mg group will receive CG5503 IR 50 mg on Day 1 and 75 mg on Day 2 to 10. All doses of study treatment should be taken with approximately 120 mL of water with or with food.
- Conditions
- Osteoarthritis, Pain Assessment, Arthralgia
- Being tested
- CG5503 IR; tapentadol
- Keywords
- Osteoarthritis, tapentadol, knee-replacement, hip replacement, pain
- Medical subject headings
- Osteoarthritis, Arthralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG5503 IR; tapentadolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome is the SPID (Sum of Pain Intensity Difference) calculated at 5 days.
Secondary outcomes (1)
Secondary efficacy outcomes include, among others, the time to the first use of rescue medication, the distribution of responder rates, and the SPID over 2 and 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 669 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 & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361582
- Sponsor's protocol ID
- CR011218
- Status last verified
- Apr 2010
- First submitted
- 4 Aug 2006
- Last updated
- 15 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease
- ClinicalTrials.gov ID
- NCT00361582
- Acronym / sponsor ID
- CR011218
- Conditions
- Osteoarthritis, Pain Assessment, Arthralgia
- Keywords
- Osteoarthritis, tapentadol, knee-replacement, hip replacement, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Aug 2006 (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 is to evaluate in patients who are eligible for elective primary total or partial joint replacement of the hip or knee due to chronic osteoarthritis the efficacy (level of pain control) of CG5503 over 5 and 10 days compared with placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR patients.
Detailed description
CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study was designed to assess the safety and tolerability of CG5503 IR in patients who need joint replacement of the hip or knee due to chronic osteoarthritis. This is a double-blind study, i.e., neither patients nor investigators will know what treatment is given. Before the start of the 10 day double-blind phase, each patient will be screened for eligibility and eligible patients will be randomly assigned to receive either CG5503 IR, oxycodone IR, or placebo (i.e., no active drug). All patients will take their treatment by mouth every 4 to 6 hours during waking hours. A total of 60 doses (up to 6 doses per day) of study treatment will be provided for each patient during the 10-day treatment phase. The study treatment will be dispensed on Day 1, and patients will take the first dose in the evening of the same day. The effectiveness of study treatment (CG5503 IR, oxycodone, or placebo) will be assessed using several measures, including 11 Point Pain Numerical Rating Scale, 5-Point Relief Numerical Rating Scale, and Patient Global Impression of Change. Using these scales, patients will indicate their pain intensity level, pain relief level, and overall status of their well-being. Safety and tolerability will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead ECG results. The null hypothesis for the study is that all CG5503 IR dosage efficacy results are equal to placebo based on the 5-day SPID in the treatment of chronic pain caused by osteoarthritis. The alternative study hypothesis is that at least 1 CG5503 IR dose effect will be different from placebo effect. CG5503 IR 50 mg, 75 mg of the base, 10 mg oxycodone or placebo for 10 days taken by mouth every 4 to 6 hours during waking hours. Patients randomized to CG5503 IR 75 mg group will receive CG5503 IR 50 mg on Day 1 and 75 mg on Day 2 to 10. All doses of study treatment should be taken with approximately 120 mL of water with or with food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of chronic osteoarthritis of the hip or the knee based on clinical and radiographic (X-Ray) criteria defined by standard accepted guidelines
- candidate (qualifies) for primary one-sided total or partial joint replacement surgery due to noninflammatory, end-stage degenerative joint disease (arthritis)
- requires daily doses of analgesic medication for chronic pain.
Key exclusion criteria (3 listed)
- History of seizure disorder or epilepsy suggested by the presence of any of the following
- History of chronic hepatitis B and C or human immunodeficiency virus, or presence of active hepatitis B and C within the past 3 months before screening
- currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressant, neuroleptics, or serotonin norepinephrine reuptake inhibitors.
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 |
|---|---|---|
| CG5503 IR; tapentadol | Drug | – |
Primary outcome
The primary efficacy outcome is the SPID (Sum of Pain Intensity Difference) calculated at 5 days.
1 secondary outcome
Secondary efficacy outcomes include, among others, the time to the first use of rescue medication, the distribution of responder rates, and the SPID over 2 and 10 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 15 Jun 2011.
- A Study to Evaluate the Effectiveness and Safety of Multiple Doses of Tapentadol(CG5503) in Patients Awaiting Joint Replacement SurgeryLink 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 & 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 3 study testing CG5503 IR; tapentadol in people with Osteoarthritis and Pain Assessment, 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 3 inclusion and 3 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 15 Jun 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 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?
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?
The primary efficacy outcome is the SPID (Sum of Pain Intensity Difference) calculated at 5 days.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2011.