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 ExtensionEstudio aleatorizado, en doble ciego, controlado con producto activo y con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de distintas dosis de CG5503 en formulación de liberación inmediata en el tratamiento del dolor agudo consecuencia de la cirugía de artroplastia total de cadera, seguido por una extensión abierta de carácter voluntario
- Conditions
- painMedDRA version: 8.1Level: LLTClassification code 10033371Term: Pain
- Registration Number
- EUCTR2006-004513-18-ES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
• Man or woman, between 18 to 80 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
• History of seizure disorder or epilepsy
• 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.
• Systemic steroid therapy within 3 months before screening, excluding inhalers or a 1-time intraoperative dose
• Undergoing concomitant surgical procedures in addition to primary total hip replacement
• History of malignancy within the past 2 years before the start of the study, with the exception of basal cell carcinoma
• History of alcohol or drug abuse in the investigator’s judgment based on subject history and physical examination
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method