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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

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ClinicalTrials.gov Identifier: NCT00364533
Recruitment Status : Terminated (Slow enrollment)
First Posted : August 15, 2006
Results First Posted : July 8, 2009
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Condition or disease Intervention/treatment Phase
Arthroplasty Drug: Tapentadol IR (CG5503) Drug: Placebo Drug: Oxycodone HCL IR Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Placebo Comparator: 003
Placebo Fixed Dose Matching placebo for 3 days
Drug: Placebo
Fixed Dose Matching placebo for 3 days

Active Comparator: 002
Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days
Drug: Oxycodone HCL IR
Fixed Dose 10 mg BID for 3 days

Experimental: 001
Tapentadol IR (CG5503) Fixed Dose 50, 75, & 100 mg BID for 3 days
Drug: Tapentadol IR (CG5503)
Fixed Dose 50, 75, & 100 mg BID for 3 days

004
Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days
Drug: Tapentadol IR (CG5503)
Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to First Rescue Pain Medication. [ Time Frame: 3 days ]
  2. The SPID at 12, 24, and 72 Hours Relative to First Dose. [ Time Frame: 3 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364533


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Locations
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United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
Sheffield, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, Arkansas
Fort Smith, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Anaheim, California, United States
Arcadia, California, United States
Glendale, California, United States
Laguna Hills, California, United States
Sacramento, California, United States
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Farmington, Connecticut, United States
United States, Florida
Boynton Beach, Florida, United States
Deland, Florida, United States
Fort Lauderdale, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Port Orange, Florida, United States
Tamarac, Florida, United States
United States, Georgia
Decatur, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Topeka, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Royal Oak, Michigan, United States
United States, New York
Albany, New York, United States
Mineola, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sewickley, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Plano, Texas, United States
United States, Utah
Murray, Utah, United States
United States, Wisconsin
Weston, Wisconsin, United States
Belgium
Aalst, Belgium
Genk, Belgium
Gent, Belgium
Leuven, Belgium
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Burlington, Ontario, Canada
Newmarket, Ontario, Canada
Oshawa, Ontario, Canada
Scarborough, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada
London, Canada
Finland
Helsinki, Finland
Tampere, Finland
Turku, Finland
New Zealand
Hamilton, New Zealand
Spain
Cadiz N/A, Spain
Madrid, Spain
Valencia, Spain
Sweden
Borås, Sweden
Hässleholm, Sweden
Uppsala, Sweden
Örebro, Sweden
United Kingdom
Aberdeen, United Kingdom
Birmingham, United Kingdom
Edinburgh, United Kingdom
Great Yarmouth, United Kingdom
London, United Kingdom
Middlesex, United Kingdom
Sheffield, United Kingdom
Wigan, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional Information:
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Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00364533     History of Changes
Other Study ID Numbers: CR011221
R331333PAI3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
KF5503/31 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
First Posted: August 15, 2006    Key Record Dates
Results First Posted: July 8, 2009
Last Update Posted: April 21, 2014
Last Verified: April 2014

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Arthralgia
Pain
Pain Assessment
Hip Replacement
Tapentadol

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Oxycodone
Tapentadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents