pain MedDRA version: 8.1 Level: LLT Classification code 10033371 Term: Pain
Conditions
Interventions
R331333
Other descriptive name: (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
P
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Man or woman, between 18 to 85 years of age, inclusive • Signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study • Physical status rated as =3 on the American Society of Anesthesiologist (ASA) rating scale (see Attachment 1) • Scheduled to undergo standard primary (non-revision) unilateral total hip replacement surgery due to non-inflammatory degenerative joint disease (NIDJD). • Baseline pain intensity =4 on an 11-point (0 to 10) Pain Intensity NRS, rated within 30 minutes before randomization • Qualifying baseline pain intensity measurements occur within 6 hours of the termination of PCA (after a minimum of 12 hours of PCA), during the postoperative surgical period. • Must be able to complete all study related procedures and requirements throughout the study period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • History of seizure disorder or epilepsy • History of malignancy within the past 2 years before start of study, with the exception of basal cell carcinoma • Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip, Hepatitis B or C, or other overt infections) or a history human immunodeficiency virus (HIV) 1 or 2. • Acute crystal-induced arthropathy within the previous 6 months before the screening period of the study • Has laboratory values reflecting severe renal insufficiency indicated by a creatinine clearance =30 mg/min. • Has laboratory values consistent with significant hepatic impairment based on alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 3 times the upper limit of normal (ULN); or evidence of significant anemia indicated by hemoglobin (Hgb) levels =8. • Uncontrolled or poorly controlled post-traumatic stress disorder generalized anxiety disorder (GAD), depression, psychiatric or other significant medical conditions • Treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or serotonin norepinephrine reuptake inhibitor (SNRI) within 2 weeks before screening, (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) • Treated with a daily opioid analgesic or combination opioid analgesic, other than those containing tramadol or codeine, for more than 30 days before screening • Contraindications to, history of allergy to, or hypersensitivity to CG5503, Oxycodone, hydromorphone, morphine, or fentanyl, or their excipients. • Chronic systemic steroid therapy within 4 weeks before screening, excluding inhalers or a 1-time intraoperative dose • Undergoing concomitant surgical procedures in addition to primary total hip replacement • History of alcohol or drug abuse in the investigator’s judgment based on subject history and physical examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy of CG5503 immediate release (IR) using the sum of pain intensity difference (SPID) over 48 hours compared to placebo, and to assess the safety and tolerability of multiple doses of CG5503 IR in subjects with acute pain following primary unilateral total hip replacement surgery over the double-blind period.;Secondary Objective: The secondary objectives include: • Comparison of the effect of CG5503 IR on the time to the first rescue pain medication during the double blind treatment period • Evaluation of the effect of CG5503 IR versus placebo with the distribution of responder rates for each time point (at 12, 24, 48, and 72 hours) • Evaluation of the efficacy of CG5503 IR by examining the total effect on pain relief and pain intensity over the 72-hour double-blind period. • Assessment of the Patient Global Impression of Change (PGIC) at the end of the double-blind treatment period. • Evaluation of the adverse event rates across treatment groups in the double-blind treatment period (especially nausea and vomiting);Primary end point(s): The primary efficacy endpoint for this study is the sum of pain intensity difference over 48 hours (SPID48). The SPID48 will be calculated as the weighted sum of the pain intensity difference (difference between baseline at qualifying period and current pain intensity) collected up to 48 hours. | — |
Countries
Belgium, Czech Republic, Estonia, Finland, France, Hungary, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed