A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis
- Conditions
- -M17M17
- Registration Number
- PER-115-06
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. The patient is male or female and is = 40 years old on the day they sign the informed consent.
2. The patient has a clinical diagnosis of osteoarthritis of the medial tibiofemoral joint of the knee for at least 6 months.
3. The patient belongs to functional class I, II or III of the ARA.
4. A patient who is potentially fertile agrees to practice abstinence or use 2 acceptable methods of birth control within the scheduled duration of the study.
5. The patient is willing to limit their consumption of alcohol to 14 doses per week.
6. The patient does not foresee a significant change in the level of strenuous physical activity during the entire study and the follow-up period.
7. The patient is considered to have an adequate general health condition to participate in this clinical study.
8. The patient knows how to read and is able to understand and complete the questionnaires and journals.
9. The patient understands the study procedures as well as the information of the alternative treatments available and the risks involved in the study, and voluntarily agrees to participate in the study by providing written informed consent.
10. The patient is ambulatory and foresees that he / she will be able to return for all the study visits within the time margins indicated in the Flow Diagram.
11. At Visit 1, the evaluation of the patient in terms of index knee pain when walking on a flat surface is = 30 mm or the patient is receiving medication for the treatment of OA pain of the index knee during = 15 days within the last 30 days.
1. The patient suffers from a type of inflammatory arthritis in the study joint, Wilson´s disease, hemochromatosis, ochronosis, primary osteochondromatosis or fibromyalgia.
2. The patient is not eligible to undergo an MRI exam due to any of the following patient factors or clinical safety criteria: a) Body weight> 280 Lbs (127 kg). b) Presence of magnetic material in the organism. c) Inability to tolerate the MRI procedure. d) Inability to meet other criteria for the quality of the exam. e) Inability to meet other criteria, as determined by the MRI center for patient safety.
3. The patient has any of the following antecedents or conditions: a) The patient has undergone a tibial osteotomy or the replacement of any component or joint surface in the index knee. b) The patient has a history of septic arthritis or intra-articular fracture of the index knee. c) The patient has a history of acute injury of the ligaments or meniscus of the index knee within the previous 2 years. d) The patient has undergone a knee arthroscopy or surgical procedure in the lower extremities within 12 months prior to Visit 1, or has undergone hip or ankle arthroscopy or podiatric surgery within 6 months. months prior to Visit 1. e) It is expected that the patient will require a surgical or arthroscopic procedure in the lower limbs within the next 18 months. f) The patient has any other medical condition or arthritic disease that could confuse or interfere with the evaluation of efficacy.
4. The patient uses patellofemoral supports, lateral orthosis with wedge in the block or insoles, or assist devices for walking such as a walker, a wheelchair or two canes.
5. The patient has a difference = 2 cm in the length of the leg or uses custom-made shoes or prostheses that fit the differences in the length of the lower limb.
6. The patient is mentally or legally disabled.
7. The patient has a significant history or current evidence of any condition, therapy, abnormality in laboratory tests or other circumstance that could complicate the interpretation of the study results or represent an additional risk to the patient.
8. The patient has a history of malignant diseases = 5 years before the signing of informed consent.
9. The patient is pregnant or breastfeeding, or expects to conceive within the scheduled duration of the study.
10. The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days prior to signing the informed consent or is unwilling to refrain from participating in another study.
11. The patient has donated blood products or has undergone a phlebotomy of> 300 mL within 8 weeks prior to signing the informed consent.
12. The patient is not likely to stick to the study procedures.
13. The patient demonstrates failure to follow the procedures required in the study.
14. The patient is a user of recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence.
15. The patient is allergic to acetaminophen / paracetamol.
16. The patient has a history of marked prolongation of the QT / QTc interval.
17. The patient has received intra-articular injections of hyaluronic acid in the lower limbs within 6 months prior to Visit 1, or anticipates needing these injections during the course of the study.
18. The patient has received intra-articular injections of glucocorticoids in the lower limbs within 3 month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A nuclear magnetic resonance of the knee (index joint) will be used.<br>Measure:Normalized volume of cartilage in the region of the medial tibial cartilage.<br>Timepoints:12 months.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Criterion 1: MRI will be used to evaluate the normalized volume of the following regions: Central medial femoral cartilage, Posterior medial femoral cartilage, Medial compartment cartilage (sum of medial tibial cartilages, Middle medial femoral and posterior medial femoral), Tibial cartilage lateral, lateral lateral femoral cartilage, posterior lateral femoral cartilage, lateral compartment cartilage (sum of the medial tibial, medial femoral, and posterior medial femoral cartilages).<br>Criterion 2: MRI will be used to evaluate the non-normalized cartilage volume, average cartilage thickness, percentage of eroded surface area, articular cartilage surface area, cartilage-bone interface area, cartilage roughness and curvature of the cartilage.<br>Measure:Secondary efficacy: 1) Normalized cartilage volume in specific regions of the affected cartilage. 2) Other end points of the NMR.<br>Timepoints:12 months.<br>