Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee MedDRA version: 9.1 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Product Name: CG5503, R331333
Product Code: CG5503, R331333
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol hydrochloride
Other descriptive name: (-)-(1R, 2R)-3-(3-dimet
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial. • Men and non-pregnant, non-lactating women. Sexually active women must be postmenopausal, surgically sterile, or practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Women must have a negative pregnancy test at screening. • At least 40 years old. • Diagnosis of OA of the knee based on ACR criteria and functional capacity class of I-III. Pain at the reference joint must be present for at least 3 months. • Taking analgesic medications for the condition for at least 3 months prior screening and dissatisfied with current therapy; subjects taking opioids must be dissatisfied with current treatment in terms of efficacy or tolerability, subjects taking non-opioids must be dissatisfied with current treatment in terms of efficacy. • Subjects requiring opioid treatment must be taking daily doses of opioid-based analgesic equivalent to =160 mg of oral morphine. • Baseline score of =5 on an 11-point NRS, calculated as the average pain intensity during the last 3 days prior to randomization. Subjects need to have a minimum of 5out of 6 possible assessments (twice daily assessments for the last 3 days of the Washout 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: • Participation in another trial concurrently, or within 30 days of enrollment into the CG5503 trial. • Previous participation in this trial or other trials with CG5503. • History of alcohol and/or drug abuse in Investigator’s judgment, based on subject’s history and physical examination. • Known to or suspected of not being able to comply with the protocol and the use of the Investigational Medicinal Product. • Any painful procedures during the trial (eg, major surgery) that may, in the opinion of the Investigator, affect the efficacy or safety assessments. • Employees of Investigator or trial site, with direct involvement in proposed trial or other studies under the direction of that Investigator or trial site, as well as family members of employees or the Investigator. • Subject has a clinically significant disease that in the Investigator’s opinion may affect efficacy or safety assessments, eg, significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, psychiatric (resulting in disorientation, memory impairment or inability to report accurately) or metabolic disturbances. • History of significant liver insufficiency; chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past 3 months. • Life-long history of seizure disorder or epilepsy. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm; Severe traumatic brain injury within 15 years (consisting of =1 of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness. • History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated. • Uncontrolled hypertension (repeated systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg). • Subjects taking prohibited medications (see protocol section prior and concomitant medication). • Laboratory values above or below limits of normal that in the investigator’s judgment may affect the safety of the subject • Subjects with severely impaired renal function. • Subject with moderately or severely impaired hepatic function, or subjects with laboratory values reflecting inadequate hepatic function (ALT, AST greater than three-fold upper limit of normal). • Clinically relevant history of hypersensitivity, allergy, or contraindication to oxycodone or paracetamol/acetaminophen (or ingredients). • Pending litigation due to chronic pain or disability. • Presence of conditions other than OA of the reference joint that could confound the assessment or self-evaluation of pain, eg, anatomical deformities, significant skin conditions such as abscess, fibromyalgia. • Surgery of the reference joint within 3 months of screening or the subject is expected to require surgical intervention on reference joint during the trial. • History and clinical signs at reference joint from crystal-induced (eg, gout, pseudogout), metabolic, infectious and autoimmune disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the efficacy and safety of orally administered CG5503 PR (base) at doses of 100-250 mg twice daily in subjects with moderate to severe chronic pain from OA of the knee;Secondary Objective: Secondary objectives include the collection of pharmacokinetic information for dose verification and population pharmacokinetic analyses.;Primary end point(s): Primary efficacy endpoint is: change from baseline of the average pain intensity over the 12-week Maintenance period of the daily pain intensity on an 11-point NRS. | — |
Countries
Austria, France, Germany, Hungary, Italy, Latvia, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed