None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with L-000904218 100 mg PO BID for 4 weeks. Those patients who received NSAIDs before entering the study will also receive acetaminophen (paracetamol) 325 mg tablets to be used as a rescue medication.
Group name:GROUP 2 Type of group
This group will be treated with L-000904218 Placebo PO BID for 4 weeks. Those patients who received NSAIDs before entering the study will also receive acetaminophen (paracetamol) 325 mg tablets to be used as a rescue medication.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a) The patient is a man or woman either postmenopausal or surgically sterilized, ≥ 40 and ≤ 65 years of age, with a clinical diagnosis osteoarthritis of the knee or hip for at least 6 months. b) The primary source of pain and / or disability of the patient is the lower extremity. c) If the patient is female, has not menstruated for more than 1 year or if menstruation was interrupted during the last year, follicle stimulating hormone (FSH) should be documented as elevated in the postmenopausal range. d) The patient is of functional class ARA I, II or III. e) The patient is willing to limit their alcohol intake and to avoid strenuous physical activity not used. f) It is considered that the patient, apart from his osteoarthritis, has a good state of health. g) The patient is able to understand and fill out the study questionnaires. h) The patient understands the study procedures and agrees to participate in the study by giving written informed consent. Only for NSAID Previous Users: i) The patient is a regular user of NSAIDs. j) The patient´s evaluation of pain when walking on a flat surface is less than 80 mm. k) At Visit 2, the patient has discontinued NSAIDs during the appropriate period of pharmacological rest. l) In Visit 2, the patient´s assessment of pain while walking in a flat surface is greater than or equal to 40 mm. m) At Visit 2, the patient´s assessment of pain while walking on a flat surface has increased by at least 15 mm. n) At Visit 2, the Global Assessment of the Condition of the Investigator´s Disease has worsened in at least 1 category. Only for Previous Users of Acetaminophen (Paracetamol): o) The patient is a regular user of acetaminophen (paracetamol) and does not use NSAIDs. p) In both Visits 1 and 2, the patient´s evaluation of pain when walking on a flat surface is greater than or equal to 40 mm. q) In both Visits 1 and 2, the Global Assessment of the Condition of the Investigator´s Disease is regular, bad or very bad. r) In both Visits 1 and 2, the Global Assessment of the Condition of the Patient´s Disease is greater than or equal to 40 mm.
Exclusion criteria
Exclusion criteria: 3375/5000 1) The patient has inflammatory arthritis. 2) The patient has a history of septic arthritis or intra-articular joint fracture of the study. 3) The patient has isolated patellofemoral disease that manifests mainly by pain in the anterior knee without tibiofemoral radiographic findings. 4) The patient has a history of acute injury to the ligaments or meniscus of the study joint within the previous 2 years. 5) The patient had an arthroscopy of the study joint within the previous 6 months. 6) The patient is mentally or legally incapacitated. 7) The patient has a history of gastric, biliary, or small bowel surgery or has a disease that causes malabsorption. 8) The patient has a history of leukemia, lymphoma, melanoma, or a myeloproliferative or myelodysplastic disease. 9) The patient has a history of any other tumor 150 mg / day. 25). The patient has had or expects to have a change in the chronic medication within the period of 1 month prior to Visit 1 or during the study. 26) The patient requires the chronic use of broad spectrum antibiotics. 28) The patient requires the chronic use of CYP3A4 inducers. 29) The patient requires treatment with warfarin, heparin or digoxin. 30) The patient requires the chronic use of CYP3A4 inhibitors. 31) The patient requires the chronic use of substrates of CYP3A4, 2C9, or 2C19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:WOMAC Pain Subscale (VAS). Measure:Primary efficacy of the treatment. Timepoints:Before treatment, during weeks 1, 2, 3 and 4. And during follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Sub-scale of Physical Function WOMAC (VAS). Global Evaluation of the Response to Patient Therapy (Likert). Global Assessment of the Condition of Patient s Disease (VAS). Global Assessment of the Condition of the Investigator s Disease (Likert). Rigidity subscale WOMAC. WOMAC general scores (VAS). Average score on the WOMAC subscales. Global Evaluation of the Response to Investigator Therapy (VAS). Pain when walking on a flat surface WOMAC (VAS). Clinical examination: Sensitivity in the Study Articulation (scale from 0 to 3 points). Number of acetaminophen tablets used as rescue medicine. Measure:Secondary efficacy of the treatment. Timepoints:Before treatment, during weeks 1, 2, 3 and 4. And during follow-up. ; Outcome name:Clinical evaluation: Counting and evaluation of adverse events, evaluation of vital signs. 12-lead electrocardiogram (specifically the PR, QRS and QTc intervals). Laboratory tests: serum biochemistry, hematological panel, urinalysis, TP). Measure:Safety of the treatment. Timepoints:Counting and evaluation of adverse events: Weeks 1, 2,3, 4 and during follow-up. Serum biochemistry, blood panel, urinalysis, TP: Before the study and weeks 1 and 4. ECG: Before the study, week 4 and to discontinue the study. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed