PER-072-05已完成未知
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
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2006年1月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
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