Chronic pain due to knee or hip osteoarthritis or low back pain of benign origin MedDRA version: 8.1 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
R331333
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Tapentadol
CAS Number: 175591-09-0
Other descriptive name: (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl- 2-methyl-propyl)-phenol hy
Sponsors
Johnson & Johnson Pharamceutical Resarch & Development, L.L.C
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant, non-lactating female subjects. Sexually active women must be post menopausal, surgically sterile, or practicing an effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. Female subjects must have a negative serum ß-HCG pregnancy test at screening. 2. At least 18 years of age. 3. Subjects must be dissatisfied with their current analgesic therapy (e.g. NSAIDS, COX-II inhibitors, opioids, paracetamol/acetaminophen). 4. Subjects have a pain intensity =4 on NRS at baseline after washout. 5. Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months. 6. 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. 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: General: 1. Participation in another trial concurently, or within 30 day of enrollment into the CG5503 trial; 2. Previous participation in this trial or other trials of CG5503; 3. History of alkohol and/or drug abuse in investigator's judgement, based on subject history and physical examination; 4. Known to or suspected of not being able to comply with the protocol and the use of the IMPs; 5. Subject is expected to require major surgical intervention during the trial; 6. Surgery of the back or reference joint within 3 months of screening; 7. Employees of investigator or trial site, with direct involvement in proposed trial or other trial under the direction of that investigator or trial site, as well as family members of the employees or the investigator; 8. Subject has a clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments. Trial specific: 1. Life-long history of seizure disorder or epilepsy; Any of the following within one 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, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness; 2. History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma; 3. Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg); 4. Subjects taking prohibited medications (see protocol Section 10.2 concomitant medications); 5. Laboratory values reflecting inadequate hepatic function (ALT, AST greater than 3 x upper limit of normal [ULN]); 6. Subjects with moderately or severely impaired renal function as defined by country-specific requirements; 7. Clinically relevant history of oxycodone or paracetamol/acetaminophen hypersensitivity or allergy, or contraindication to those substances; 8. Past or pending litigation due to chronic pain or disability; 9. Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is the evaluation of the safety profile of CG5503 PR base at doses ranging between 100 mg and 250 mg BID over long term exposure of up to one year.;Secondary Objective: • Assessment of CG5503 PR and oxycodone CR dose requirements during long-term exposure. • Evaluation of symptoms related to constipation using the Patient’s Assessment of Constipation Symptom (PAC-SYM). • Evaluation of sleep quality by using Sleep Questionnaire (SQ). • Evaluation for symptoms of withdrawal following discontinuation of treatment using both the Clinical Opiate Withdrawal Scale (COWS) and the Subjective Opiate Withdrawal Scale (SOWS) questionnaires. • Assessment of pain intensity efficacy over the one-year trial period, based on pain intensity scores using an 11-point numerical rating scale (NRS). • Assessment of efficacy based on the subject’s and Investigator’s global assessment of the IMP. • Assessment of efficacy based on Patient’s Global Impression of Change (PGIC) using a 7-point verbal rating scale. • Assessment of quality of life based on EuroQuol-5 Dimension (EQ-5D). • Assessment of quality of life based on Short Form-36 Health Survey (SF-36®);Primary end point(s): No formal statistical testing will be performed in this study. The enrollment will target a minimum exposure of approximately 300 subjects to CG5503 PR for approximately 6 months and approximately 100 subjects for approximately one year. | — |
Countries
Austria, Czech Republic, France, Germany, Ireland, Netherlands, Spain, United Kingdom
Outcome results
None listed