Study Stopped
Slow enrollment
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 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
3 other identifiers
interventional
367
8 countries
77
Brief 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 patients completed the double blind period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2006
Shorter than P25 for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedResults Posted
Study results publicly available
July 8, 2009
CompletedApril 21, 2014
April 1, 2014
1.2 years
August 11, 2006
December 19, 2008
April 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
48 hours
Secondary Outcomes (2)
Time to First Rescue Pain Medication.
3 days
The SPID at 12, 24, and 72 Hours Relative to First Dose.
3 days
Study Arms (4)
003
PLACEBO COMPARATORPlacebo Fixed Dose Matching placebo for 3 days
002
ACTIVE COMPARATOROxycodone HCL IR Fixed Dose 10 mg BID for 3 days
001
EXPERIMENTALTapentadol IR (CG5503) Fixed Dose 50, 75, \& 100 mg BID for 3 days
004
OTHERTapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 \& 100 mg BID for 9 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (77)
Unknown Facility
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Sheffield, Alabama, United States
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Phoenix, Arizona, United States
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Fort Smith, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Arcadia, California, United States
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Glendale, California, United States
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Laguna Hills, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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Farmington, Connecticut, United States
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Boynton Beach, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Port Orange, Florida, United States
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Tamarac, Florida, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Royal Oak, Michigan, United States
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Albany, New York, United States
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Mineola, New York, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Sewickley, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Plano, Texas, United States
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Murray, Utah, United States
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Weston, Wisconsin, United States
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Aalst, Belgium
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Genk, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Halifax, Nova Scotia, Canada
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Burlington, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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London, Canada
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Helsinki, Finland
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Tampere, Finland
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Turku, Finland
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Hamilton, New Zealand
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Cadiz, Spain
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Madrid, Spain
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Valencia, Spain
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Borås, Sweden
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Hässleholm, Sweden
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Örebro, Sweden
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Uppsala, Sweden
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Edinburgh, United Kingdom
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Great Yarmouth, United Kingdom
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London, United Kingdom
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Middlesex, United Kingdom
Unknown Facility
Sheffield, United Kingdom
Unknown Facility
Wigan, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Sponsor terminated study, sample size not reached. The protocol section describes 4 study arms defining the treatment groups in the study design. The participant flow module describes the 5 treatment groups analyzed for the primary endpoint
Results Point of Contact
- Title
- Senior Director, Clinical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2006
First Posted
August 15, 2006
Study Start
October 1, 2006
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 21, 2014
Results First Posted
July 8, 2009
Record last verified: 2014-04