A 4-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF L-000904218 IN PATIENTS WITH KNEE OR HIP OSTEOARTHRITIS
- Conditions
- -M169 Coxarthrosis, unspecified-M179 Gonarthrosis, unspecifiedCoxarthrosis, unspecifiedGonarthrosis, unspecifiedM169M179
- Registration Number
- PER-072-05
- 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
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.
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 <5 years before Visit 1.
10) The patient has a history of any disease that could confuse the results of the study or represent an additional risk to the patient.
11) The patient is a current user of any illicit drug or has a recent history of drug or alcohol abuse within the past 5 years.
12) The patient is allergic to acetaminophen (paracetamol) or to any of the components of L-000904218.
13) The patient is considered morbidly obese.
4) The patient has clinically significant abnormalities on physical examination or laboratory tests.
15) At Visit 2, the patient has a positive fecal occult blood test.
16) The patient has donated a unit of blood or plasma, has undergone surgery or has participated in another study with an investigational drug within the period of 1 month before Visit 1.
17) The patient has previously participated in a study with L-000904218.
18) The patient has received intra-articular injections of: Corticosteroids or hyaluronic acid in the study joint within 3 months prior to Visit 1.
19) The patient has received oral, intravenous corticosteroids, or intramuscular within the period of 1 month before Visit 1.
20) The patient has received any immunosuppressive medication within 3 months prior to Visit 1.
21) Patients who have recently started or have had a change in the dose or brand of glucosamine or chondroitin sulfate will be allowed within 6 months prior to Visit 1.
22) The patient uses herbal remedies after Visit 1.
23) The patient has used topical oral or systemic analgesic medications (other than NSAIDs, selective COX-2 inhibitors, or acetaminophen) within 2 weeks prior to Visit 1.
24) The patient requires a chronic treatment with aspirin> 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:WOMAC Pain Subscale (VAS).<br><br>Measure:Primary efficacy of the treatment.<br>Timepoints:Before treatment, during weeks 1, 2, 3 and 4. And during follow-up.<br>
- Secondary Outcome Measures
Name Time Method