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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.

Tracking Information
First Submitted Date  ICMJE August 11, 2006
First Posted Date  ICMJE August 15, 2006
Results First Submitted Date December 19, 2008
Results First Posted Date July 8, 2009
Last Update Posted Date April 21, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2006)
The primary efficacy outcome for this study is SPID48 (i.e., the sum of pain intensity difference over 48 hours relative to the first dose). SPID will be evaluated over 12, 24, 48, and 72 hours after the first dose of study drug is taken.
Change History Complete list of historical versions of study NCT00364533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2010)
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2006)
Secondary effectiveness outcomes include, among others, the effect of CG5503 IR on the time to the need for the first rescue pain medication during the double-blind treatment period, and the SPID at 12, 24, and 72 hours relative to first dose.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty
Intervention  ICMJE
  • Drug: Tapentadol IR (CG5503)
    Fixed Dose 50, 75, & 100 mg BID for 3 days
  • Drug: Placebo
    Fixed Dose Matching placebo for 3 days
  • Drug: Oxycodone HCL IR
    Fixed Dose 10 mg BID for 3 days
  • Drug: Tapentadol IR (CG5503)
    Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days
Study Arms
  • Placebo Comparator: 003
    Placebo Fixed Dose Matching placebo for 3 days
    Intervention: Drug: Placebo
  • Active Comparator: 002
    Oxycodone HCL IR Fixed Dose 10 mg BID for 3 days
    Intervention: Drug: Oxycodone HCL IR
  • Experimental: 001
    Tapentadol IR (CG5503) Fixed Dose 50, 75, & 100 mg BID for 3 days
    Intervention: Drug: Tapentadol IR (CG5503)
  • 004
    Tapentadol IR (CG5503) Flexible Dose q4-6 hr Tapentadol IR 50 & 100 mg BID for 9 days
    Intervention: Drug: Tapentadol IR (CG5503)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 18, 2010)
367
Original Enrollment  ICMJE
 (submitted: August 11, 2006)
1100
Actual Study Completion Date December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Finland,   New Zealand,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Australia,   Czech Republic,   Estonia,   France,   Hungary,   Latvia,   Lithuania,   Poland,   Portugal,   Romania,   Slovakia
 
Administrative Information
NCT Number  ICMJE NCT00364533
Other Study ID Numbers  ICMJE CR011221
R331333PAI3001 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
KF5503/31 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Grünenthal GmbH
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP