ArthroplastyPhase 3NCT00364533
A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For Safety
A Phase 3 study testing Tapentadol IR (CG5503) and Oxycodone HCL IR in people with Arthroplasty, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 77 sites in 8 countries.
Trial summary
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Tapentadol IR (CG5503) and Oxycodone HCL IR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 367 participants
- Where
- 77 sitesin 8 countries
- Study dates
- Oct 2006to Dec 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection)
- Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization
- Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study
Who cannot join
- Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
- history of malignancy within the past 2 years before starting the study
- history of alcohol or drug abuse
- evidence of active infections that may spread to other areas of the body
- clinical laboratory values reflecting moderate or severe kidney insufficiency
- currently treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or selective norepinephrine reuptake inhibitor (SNRI), (selective serotonin reuptake inhibitor [SSRI] treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose)
Trial locations and contacts
77 sites in 8 countries.
77 sites in 8 countries
United States45 sites
Study site
Albany, New York
Study site
Anaheim, California
Study site
Arcadia, California
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Boynton Beach, Florida
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Dallas, Texas
Study site
Decatur, Georgia
Study site
DeLand, Florida
Study site
Denver, Colorado
Study site
Farmington, Connecticut
Study site
Fort Lauderdale, Florida
Study site
Fort Smith, Arkansas
Study site
Glendale, California
Study site
Grapevine, Texas
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Laguna Hills, California
Study site
Little Rock, Arkansas
Study site
Lubbock, Texas
Study site
Miami, Florida
Study site
Mineola, New York
Study site
Mobile, Alabama
Study site
Murray, Utah
Study site
Nashville, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Peoria, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Plantation, Florida
Study site
Port Orange, Florida
Study site
Royal Oak, Michigan
Study site
Sacramento, California
Study site
San Francisco, California
Study site
Sewickley, Pennsylvania
Study site
Sheffield, Alabama
Study site
Tamarac, Florida
Study site
Topeka, Kansas
Study site
Weston, Wisconsin
Canada9 sites
Study site
Burlington, Ontario
Study site
Halifax, Nova Scotia
Study site
London
Study site
Montreal, Quebec
Study site
Newmarket, Ontario
Study site
Oshawa, Ontario
Study site
Scarborough Village, Ontario
Study site
Thunder Bay, Ontario
Study site
Toronto, Ontario
United Kingdom8 sites
Study site
Aberdeen
Study site
Birmingham
Study site
Edinburgh
Study site
Great Yarmouth
Study site
London
Study site
Middlesex
Study site
Sheffield
Study site
Wigan
Belgium4 sites
Study site
Aalst
Study site
Genk
Study site
Ghent
Study site
Leuven
Sweden4 sites
Study site
Borås
Study site
Hässleholm
Study site
Örebro
Study site
Uppsala
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 the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
The purpose of this study is to test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.
Read the detailed description
Patients undergoing hip replacement often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503, in an immediate release, (IR) formulation, compared with no drug (placebo) or one dose level of oxycodone (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain from hip replacement surgery. The study will include a blinded 72 hour in-patient phase immediately following hip replacement surgery, during which patients will be treated with either 50-, 75-, or 100-mg CG5503 base IR, a placebo, or 10-mg oxycodone, and pain relief will be periodically assessed. Following this phase, patients wishing to continue treatment with CG5503 IR may enter an outpatient voluntary nonrandomized, open-label extension phase for 9 days during which they will receive 50- or 100-mg CG5503 IR. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR) and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and oxycodone. The null hypothesis for the study is that efficacy results for all CG5503 IR dosage groups are equal to placebo based on the mean sum of pain intensity difference at 48 hours. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours. CG5503 base IR 50, or 75, or 100 mg, or oxycodone 10 mg, or placebo, 1 capsule taken by mouth every 4 to 6 hours during the 72 hour postsurgery phase of the study (one extra dose is allowed, if needed for pain); and CG5503, 50 mg base capsules, 1 to 2 tablets taken by mouth every 4 to 6 hours for up to 9 days during the open label portion of the study. All doses of study treatment will be taken with approximately 120 mL of water with or with food.
- Conditions
- Arthroplasty
- Being tested
- Tapentadol IR (CG5503), Placebo, Oxycodone HCL IR
- Keywords
- Arthralgia, Pain, Pain Assessment, Hip Replacement, Tapentadol
- Medical subject headings
- Arthralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapentadol IR (CG5503)Drug
Fixed Dose 50, 75, \& 100 mg BID for 3 days
PlaceboDrug
Fixed Dose Matching placebo for 3 days
Oxycodone HCL IRDrug
Fixed Dose 10 mg BID for 3 days
Tapentadol IR (CG5503)Drug
Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days
| Study group | Role | What they receive |
|---|---|---|
| 003 | Placebo comparator | Placebo Fixed Dose Matching placebo for 3 days Receives: Drug: Placebo |
| 002 | Active comparator | Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days Receives: Drug: Oxycodone HCL IR |
| 001 | Experimental | Tapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days Receives: Drug: Tapentadol IR (CG5503) |
| 004 | Other | Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days Receives: Drug: Tapentadol IR (CG5503) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Difference Over 48 Hours (SPID48)
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
Measured: 48 hours
Secondary outcomes (2)
Time to First Rescue Pain Medication.
Measured: 3 days
The SPID at 12, 24, and 72 Hours Relative to First Dose.
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
Measured: 3 days
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 startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: Slow enrollment
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.
- Other trials for ArthroplastyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal GmbH
- Responsible party
- Sponsor
- 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
- NCT00364533
- Sponsor's protocol ID
- CR011221
- Other IDs
- R331333PAI3001, KF5503/31
- Status last verified
- Apr 2014
- First submitted
- 11 Aug 2006
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. 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 the Treatment of Acute Pain From Total Hip Replacement Surgery Followed by a Voluntary Open-Label Extension
- ClinicalTrials.gov ID
- NCT00364533
- Acronym / sponsor ID
- CR011221
- Conditions
- Arthroplasty
- Keywords
- Arthralgia, Pain, Pain Assessment, Hip Replacement, Tapentadol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 367 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
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 8 Jul 2009
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 test in patients who have had hip replacement surgery the effectiveness (level of pain control) and the safety of 3 different dose levels of CG5503 compared with placebo and with 10-mg oxycodone during the 72-hour double-blind period and to assess the safety of the drug for 9 days after patients completed the double blind period.
Detailed description
Patients undergoing hip replacement often experience moderate to severe acute pain post-surgery. Normally such pain is controlled when patients receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. CG5503, a newly synthesized drug also acts as a centrally acting pain reliever but has a dual mode of action. The aim of this study is to investigate the effectiveness (level of pain control) and safety (side effects) of 3 dose levels of CG5503, in an immediate release, (IR) formulation, compared with no drug (placebo) or one dose level of oxycodone (an opioid commonly used to treat post-surgical pain). This study is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, multicenter study to evaluate the treatment of acute pain from hip replacement surgery. The study will include a blinded 72 hour in-patient phase immediately following hip replacement surgery, during which patients will be treated with either 50-, 75-, or 100-mg CG5503 base IR, a placebo, or 10-mg oxycodone, and pain relief will be periodically assessed. Following this phase, patients wishing to continue treatment with CG5503 IR may enter an outpatient voluntary nonrandomized, open-label extension phase for 9 days during which they will receive 50- or 100-mg CG5503 IR. Assessments of pain relief include the pain intensity numeric rating scale (PI), pain relief numeric rating scale (PAR) and patient global impression of change scale (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests. Venous blood samples will be collected for the determination of serum concentrations of CG5503 and oxycodone. The null hypothesis for the study is that efficacy results for all CG5503 IR dosage groups are equal to placebo based on the mean sum of pain intensity difference at 48 hours. The alternative study hypothesis is that at least 1 dose strength of CG5503 will be different from placebo in controlling pain at 48 hours. CG5503 base IR 50, or 75, or 100 mg, or oxycodone 10 mg, or placebo, 1 capsule taken by mouth every 4 to 6 hours during the 72 hour postsurgery phase of the study (one extra dose is allowed, if needed for pain); and CG5503, 50 mg base capsules, 1 to 2 tablets taken by mouth every 4 to 6 hours for up to 9 days during the open label portion of the study. All doses of study treatment will be taken with approximately 120 mL of water with or with food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 003 | Placebo comparator | Drug: PlaceboPlacebo Fixed Dose Matching placebo for 3 days |
| 002 | Active comparator | Drug: Oxycodone HCL IROxycodone HCL IR Fixed Dose 10 mg BID for 3 days |
| 001 | Experimental | Drug: Tapentadol IR (CG5503)Tapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days |
| 004 | Other | Drug: Tapentadol IR (CG5503)Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to degenerative joint disease (arthritis), not due to some inflammatory process, (eg. infection)
- Baseline pain intensity >= 4 on an 11-point (0 to 10) Pain Intensity rating scale, rated within 30 minutes before randomization
- Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the study
Key exclusion criteria (6 listed)
- Patients will be excluded from the study if they have a history of seizure disorder or epilepsy
- history of malignancy within the past 2 years before starting the study
- history of alcohol or drug abuse
- evidence of active infections that may spread to other areas of the body
- clinical laboratory values reflecting moderate or severe kidney insufficiency
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 IR (CG5503)Fixed Dose 50, 75, \& 100 mg BID for 3 days | Drug | 001 |
| PlaceboFixed Dose Matching placebo for 3 days | Drug | 003 |
| Oxycodone HCL IRFixed Dose 10 mg BID for 3 days | Drug | 002 |
| Tapentadol IR (CG5503)Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days | Drug | 004 |
Primary outcome
Sum of Pain Intensity Difference Over 48 Hours (SPID48)
Time frame: 48 hours
The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine.
2 secondary outcomes
Time to First Rescue Pain Medication.
Time frame: 3 days
The SPID at 12, 24, and 72 Hours Relative to First Dose.
Time frame: 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain After Hip Replacement Surgery Compared With Oxycodone and Placebo Followed by a Voluntary Open-Label Extension For SafetyLink 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.
77 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tapentadol IR (CG5503) and Oxycodone HCL IR in people with Arthroplasty, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 77 sites in 8 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Canada, United Kingdom, Belgium, Sweden and 3 more countries. 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. Some participants in this study may receive a placebo. 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 8 Jul 2009). 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?
Sum of Pain Intensity Difference Over 48 Hours (SPID48) (time frame: 48 hours). 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 21 Apr 2014.