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A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.

This study has been completed.

Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00613938
  Purpose

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have had a bunionectomy.


Condition Intervention Phase
Arthralgia
Pain Assessment
Hallux Valgus
Bunion
Drug: Tapentadol (CG5503)
Drug: oxycodone
Drug: placebo
Phase III

Drug Information available for:   Oxycodone    Oxycodone hydrochloride    Tapentadol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:   A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The primary efficacy outcome for this study is the SPID-48 (i.e., the sum of pain intensity difference at 48 hours) relative to the first dose. Pain intensity will be evaluated at 12, 24, 48, and 72 hours after the first dose of study drug is taken. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes include the effect of tapentadol (CG5503) IR on the time to the first use of rescue pain medication, the SPID at 12, 24, and 72 hours relative to first dose, and the incidence of the adverse events of nausea, vomiting, and constipation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:   897
Study Start Date:   January 2008
Study Completion Date:   October 2008

Arms Assigned Interventions
001: Experimental Drug: Tapentadol (CG5503)
50mg capsule q4-6 hrs for 3 days
002: Experimental Drug: Tapentadol (CG5503)
75mg capsule q4-6 hrs for 3 days
003: Active Comparator Drug: oxycodone
10mg capsule q4-6 hrs for 3 days
004: Placebo Comparator Drug: placebo
1 capsule q4-6 hrs for 3 days

Detailed Description:

Patients undergoing bunionectomy 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, and less frequently, respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an immediate release (IR) formulation, also acts as a centrally acting analgesic 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 2 dose levels of tapentadol (CG5503) IR compared to 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 is received), active- and placebo-controlled, parallel-group, multicenter study to evaluate treatment of the acute pain from bunionectomy. The study will include a blinded 72 hour inpatient (the patient will stay in the facility where the procedure is done) phase immediately following bunionectomy, during which patients will be treated with either 50- or 75-mg tapentadol (CG5503) IR, a placebo, or 10-mg oxycodone IR, and pain relief will be periodically assessed. Assessments of pain intensity (PI) and pain relief (PAR) are obtained using the numerical rating scale, and the patient global impression of change scale (PGIC) will measure overall patient status. 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 tapentadol (CG5503) and oxycodone. The study hypotheses are that at least one tapentadol (CG5503) IR dose will be different from placebo in controlling patients pain at 48 hours, followed by establishing that at least one tapentadol (CG5503) IR dose will be non-inferior compared with oxycodone IR (oxycodone IR is not clinically significantly better than a tapentadol (CG5503) IR dose). A comparison of the incidence rate of the adverse events of nausea and/or vomiting, and the incidence rate of the adverse event of constipation, between tapentadol (CG5503) IR and oxycodone IR will also be performed.

Tapentadol (CG5503) IR 50 or 75 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 (acetaminophen is also allowed during the first 12 hours on Day 1, if needed for pain). All doses of study treatment will be taken with approximately 120 mL of water with or without food.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients must undergo primary unilateral first metatarsal bunionectomy
  • Pain intensity must be moderate to severe following removal of a continuous popliteal sciatic block
  • Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active

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 severe renal insufficiency
  • Moderately or severely impaired hepatic function
  • Currently treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613938

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Grünenthal GmbH

Investigators
Study Director:     Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial     Johnson & Johnson Pharmaceutical Research & Development, L.L.C.    
  More Information


Responsible Party:   Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Associate Director, Clinical Program Manager )
Study ID Numbers:   CR014116, KF5503/38
First Received:   January 31, 2008
Last Updated:   November 13, 2008
ClinicalTrials.gov Identifier:   NCT00613938
Health Authority:   United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Acute pain  
bunionectomy  
tapentadol  

Study placed in the following topic categories:
Hallux Valgus
Signs and Symptoms
Musculoskeletal Diseases
Joint Diseases
Oxycodone
Pain
Congenital Abnormalities
Foot Deformities
Arthralgia

ClinicalTrials.gov processed this record on November 19, 2008




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