A research study to evaluate the efficacy, safety and tolerability of the medicine CR4056 administered for 2 weeks to patients with knee osteoartritis affected by moderate to severe chronic pain.
- Conditions
- Moderate to severe chronic pain due to knee osteoarthritis with or without neuropathic component.MedDRA version: 18.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2015-001136-37-GB
- Lead Sponsor
- Rottapharm Biotech S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 213
1. Signed and dated informed consent obtained before undergoing any trial-specific procedure
2. Male or female aged =40 years and =75.
3. Diagnosis of primary OA of the knee of =6 months before the Screening Visit. The diagnosis must be confirmed at Screening Visit based on American College of Radiology (ACR) clinical and radiological criteria (X-ray must be performed during Screening Visit if not already available in the 24 months preceding the study):
-Knee pain
-X-ray osteophytes and at least one of the following:
age >50 years
morning stiffness <30 minutes duration
crepitus on active motion
4. Kellgren-Lawrence score II-III
5. Value =3 and =9 points on the WOMAC Pain Subscale (Appendix I), regardless of current analgesic/anti-inflammatory treatment at screening
6. Pain present for =15 days of each month in the 3 months before study entry
7. Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
1. Rheumatological diseases other than OA (e.g., rheumatoid arthritis, other inflammatory arthritis, acute joint trauma, gout, pseudo gout, Paget’s disease).
2. Clinical diagnosis of fibromyalgia.
3. Severe pain (regardless of the location of pain) caused by other diseases, trauma, or surgery.
4. In case of multiple painful OA joints, primary location of pain other than the knee.
5. Joint replacement at any knee.
6. Significant surgical procedures (other than joint replacement) at any knee =12 months before the Screening Visit.
7. Planned surgical procedure at any knee during the study.
8. Thrombocytopenia or any coagulation or hematopoietic disease.
9. Seizure (excluding pediatric febrile seizures), schizophrenia, bipolar disorder, uncontrolled major depression, generalized anxiety disorder (=6 months before the Screening Visit). Patients who are on stable therapy for depression or anxiety (except on the medications reported in Appendix IV) are eligible for the study.
10. Cardiac arrhythmia, congestive heart failure, coronary heart disease, class III/IV angina, acute myocardial infarction (=6 months before the Screening Visit).
11. Acute hepatitis (=3 months before the Screening Visit), chronic hepatitis and HIV infection.
12. Malignancy (other than basal cell carcinoma of the skin) active =12 months before the Screening Visit.
13. Patients with a personal or a family history of gallstone disease.
14. Stroke, intracranial hematoma, moderate or severe traumatic brain injury (Glasgow coma scale <13 or loss of consciousness for more than 30 minutes) or an intracranial operation =12 months before the Screening Visit.
15. History of alcohol or drug abuse =12 months before the Screening Visit.
16. Known allergy or hypersensitivity to paracetamol.
17. Significant respiratory disease (if treatment with prohibited medication, e.g. systemic steroids, is required)
18. Gastrointestinal diseases that are known to interfere with the absorption or excretion of medications.
19. Any clinically relevant disease that in the Investigator’s opinion may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation, (gastrointestinal, blood, endocrine, metabolic, neurological, or psychiatric disorders).
20. Platelet count <200.000/µL.
21. Serum alkaline-phosphatase, or gamma-glutamyl-transferase, or lipase greater than 3-fold the upper limit of normal (ULN); alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN.
22. Estimated creatinine clearance less than 60 mL/min/1.73 m2 (MDRD).
23. 12-lead electrocardiogram (ECG) with clinically relevant findings.
24. Treatment with strong opioids (=30 days before the Screening Visit). Patients who are taking weak and atypical opioids can be enrolled in the study.
25. Intra-articular visco-supplementation at any knee (=6 months before the Screening Visit).
26. Intra-articular or topical steroids, topical NSAIDs at any knee (=3 months and = 1 week before the Screening Visit, respectively).
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