OsteoarthritisPhase 3NCT00364546
A Study to Evaluate 90-Day Safety of Tapentadol(CG5503) Immediate Release (IR) or Oxycodone Immediate Release in Patients With Chronic Pain
A Phase 3 study testing CG 5503;tapentadol in people with Osteoarthritis and Pain Intensity Assessment, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Pain Intensity Assessment, Arthralgia
- What is being tested?
- CG 5503;tapentadol
- How many people
- 877 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
- require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder
- post-washout baseline pain intensity score >4 on an 11-point numerical rating scale
Who cannot join
- History of seizure disorder or epilepsy
- uncontrolled hypertension
- currently treated with monoamine oxidase inhibitors
- systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
- history of malignancy within the past 2 years, with the exception of basal cell carcinoma
About this study
Official title: A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
The purpose of this study is to evaluate the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.
Read the detailed description
CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is designed to assess the safety of CG5503 Immediate Release (IR) in men and women who are 18 years of age or older and who have had chronic (for at least 3 months) low-back pain or chronic pain from osteoarthritis of the hip or knee, and who require daily analgesic medication. In this double blind study (neither patients nor investigators will know what treatment is given), patients will be randomly (patients are assigned different treatments based on chance) assigned to receive either CG5503 base IR or oxycodone IR to begin a 90 day treatment during which each patient will return to the medical facility every 2 weeks. For the CG5503 IR group, patients will take 50 or 100 mg orally every 4 to 6 hours as needed to a maximum dose of 600 mg per day. Oxycodone IR patients will take 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day. Patients may continue taking their regular, stable, non-opioid medication throughout the study. The effectiveness of study treatment (CG5503 base IR or oxycodone) will be assessed with 11-Point Numerical Rating Scale and Patient Global Impression of Change. Using these scales, patients will indicate their pain intensity level and overall status of their well-being. Opioid withdrawal symptoms of CG5503 IR dose of 50 or 100 mg will be assessed with clinical opioid withdrawal scale [Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale (COWS)] at the end of treatment. Using these scales, patients will indicate the physical components of drug withdrawal and the severity of symptoms associated with rapid withdrawal. Safety will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead electrocardiogram (ECG) results. Constipation, vomiting, and sleep assessments will be performed. No formal hypothesis testing will be done in this study. For the CG5503 IR group, patients will take a flexible dose of 50 or 100 mg orally every 4 to 6 hours as needed to a maximum dose of 600 mg per day for 90 days. Oxycodone IR patients will take a flexible dose of 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day for 90 days.
- Conditions
- Osteoarthritis, Pain Intensity Assessment, Arthralgia, Sciatica, Low Back Pain
- Being tested
- CG 5503;tapentadol
- Keywords
- Osteoarthritis, Pain, Low Back Pain, Hip Pain, Knee Pain, Backache, tapentadol
- Medical subject headings
- Osteoarthritis, Arthralgia, Sciatica, Low Back Pain, Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG 5503;tapentadolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
Secondary outcomes (1)
The secondary outcomes, among others, include COWS and SOWS assessments; patient assessment of constipation symptoms; vomiting and sleep assessments; pain intensity assessment; patient global impression of change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 877 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
- NCT00364546
- Sponsor's protocol ID
- CR011212
- Status last verified
- Apr 2010
- First submitted
- 11 Aug 2006
- Last updated
- 9 Jun 2011
- Results posted
- No
Publications
Vorsanger G, Xiang J, Biondi D, Upmalis D, Delfgaauw J, Allard R, Moskovitz B. Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients. Pain Res Manag. 2011 Jul-Aug;16(4):245-51. doi: 10.1155/2011/323985.
PubMed 22059194Hale M, Upmalis D, Okamoto A, Lange C, Rauschkolb C. Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study. Curr Med Res Opin. 2009 May;25(5):1095-104. doi: 10.1185/03007990902816970.
PubMed 19301989
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or Knee
- ClinicalTrials.gov ID
- NCT00364546
- Acronym / sponsor ID
- CR011212
- Conditions
- Osteoarthritis, Pain Intensity Assessment, Arthralgia, Sciatica, Low Back Pain
- Keywords
- Osteoarthritis, Pain, Low Back Pain, Hip Pain, Knee Pain, Backache, tapentadol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 877 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 15 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 the safety of CG5503 base Immediate Release(IR) 50 mg or 100 mg taken every 4 to 6 hours as needed over the long-term exposure of 90 days in patients who have chronic pain.
Detailed description
CG5503 is a centrally active pain-relieving drug being investigated for the treatment of acute and chronic pain. This study is designed to assess the safety of CG5503 Immediate Release (IR) in men and women who are 18 years of age or older and who have had chronic (for at least 3 months) low-back pain or chronic pain from osteoarthritis of the hip or knee, and who require daily analgesic medication. In this double blind study (neither patients nor investigators will know what treatment is given), patients will be randomly (patients are assigned different treatments based on chance) assigned to receive either CG5503 base IR or oxycodone IR to begin a 90 day treatment during which each patient will return to the medical facility every 2 weeks. For the CG5503 IR group, patients will take 50 or 100 mg orally every 4 to 6 hours as needed to a maximum dose of 600 mg per day. Oxycodone IR patients will take 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day. Patients may continue taking their regular, stable, non-opioid medication throughout the study. The effectiveness of study treatment (CG5503 base IR or oxycodone) will be assessed with 11-Point Numerical Rating Scale and Patient Global Impression of Change. Using these scales, patients will indicate their pain intensity level and overall status of their well-being. Opioid withdrawal symptoms of CG5503 IR dose of 50 or 100 mg will be assessed with clinical opioid withdrawal scale [Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale (COWS)] at the end of treatment. Using these scales, patients will indicate the physical components of drug withdrawal and the severity of symptoms associated with rapid withdrawal. Safety will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead electrocardiogram (ECG) results. Constipation, vomiting, and sleep assessments will be performed. No formal hypothesis testing will be done in this study. For the CG5503 IR group, patients will take a flexible dose of 50 or 100 mg orally every 4 to 6 hours as needed to a maximum dose of 600 mg per day for 90 days. Oxycodone IR patients will take a flexible dose of 10 or 15 mg orally every 4 to 6 hours as needed to a maximum dose of 90 mg per day for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A clinical diagnosis of one of the following: low-back pain of non-malignant origin for at least 3 months, osteoarthritis of the knee or hip for at least 3 months
- require daily doses of analgesia medication for chronic pain that is consistent with or makes them candidates for treatment at Step 2 or higher of the WHO Pain Relief Ladder
- post-washout baseline pain intensity score >4 on an 11-point numerical rating scale
Key exclusion criteria (5 listed)
- History of seizure disorder or epilepsy
- uncontrolled hypertension
- currently treated with monoamine oxidase inhibitors
- systemic steroid therapy, excluding inhalers or topical steroids, within 3 months before screening
- history of malignancy within the past 2 years, with the exception of basal cell carcinoma
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 |
|---|---|---|
| CG 5503;tapentadol | Drug | – |
Primary outcome
The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.
1 secondary outcome
The secondary outcomes, among others, include COWS and SOWS assessments; patient assessment of constipation symptoms; vomiting and sleep assessments; pain intensity assessment; patient global impression of change.
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 9 Jun 2011.
- Derived from this study: PubMed 22059194Vorsanger G, Xiang J, Biondi D, Upmalis D, Delfgaauw J, Allard R, Moskovitz B. Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients. Pain Res Manag. 2011 Jul-Aug;16(4):245-51. doi: 10.1155/2011/323985.
- Derived from this study: PubMed 19301989Hale M, Upmalis D, Okamoto A, Lange C, Rauschkolb C. Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study. Curr Med Res Opin. 2009 May;25(5):1095-104. doi: 10.1185/03007990902816970.
- A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 (Tapentadol HCl) Immediate Release or Oxycodone Immediate Release in Subjects With Chronic Pain From Low Back Pain or Osteoarthritis of the Hip or KneeLink 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 CG 5503;tapentadol in people with Osteoarthritis and Pain Intensity 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 5 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 9 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 outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.. 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 NCT00364546, which also lists 2 linked publications.
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 9 Jun 2011.