NCT02335346已完成3 期
An Open Label Extension Study of Phase 3 Trial of Duloxetine in Patients With Osteoarthritis and Knee Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of duloxetine in participants with osteoarthritis and knee pain. The study will last for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Consecutive Participants)
- •Participants who have completed the 15-week treatment in the preceding study HMGX.
- •(New Participants)
- •Participants with present osteoarthritis (OA) based on American College of Rheumatology (ACR) classification of idiopathic OA of the knee.
- •Have pain for ≥14 days of each month for 3 months prior to study entry.
- •Have a score of ≥4 on the BPI average pain score at the start of the study.
- •(Consecutive and New Participants)
- •Females of child-bearing potential must test negative (-) on a pregnancy test.
排除标准
- •(New Participants)
- •Participants who have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
- •Participants who have major depressive disorder as determined using depression module of the Mini-International Neuropsychiatric Interview (M.I.N.I.).
- •Participants who have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 1 week.
- •Participants who have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee or osteotomy at any time.
- •Participants have a prior synovial fluid analysis showing a white blood cell (WBC) ≥2000 cubic millimeters (mm3) that is indicative of a diagnosis other than OA.
- •Participants who have a history of having more than one medical allergy.
- •Are non-ambulatory or require the use of crutches or a walker.
- •Have frequent falls that could result in hospitalization or could compromise response to treatment.
- •Have a history of drug abuse or dependence within the past year, including alcohol and excluding nicotine and caffeine.
- •Have a positive urine drug screen for any substances of abuse or excluded medication.
- •Have received administration of another investigational drug within the 30 days prior to enrollment.
- •Have had previous exposure to duloxetine or completed/withdrawn from any study investigating duloxetine.
- •(Consecutive and New Participants)
- •Participants who have serious cardiovascular, hepatic, renal, endocrine, respiratory, or hematologic illness, peripheral vascular disease, or other medical condition or neuropsychiatric conditions or clinically significant laboratory abnormalities or electrocardiographic abnormalities.
- •Participants who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) higher than 100 international units per liter (IU/L) or total bilirubin higher than 1.6 milligrams/deciliter (mg/dL).
- •Participants having serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or receiving renal dialysis.
- •Participants who have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis and Type 1 diabetes).
- •Participants who have uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.
- •Participants who have end stage bone disease or surgery planned during the trial for the index joint.
- •Participants treated with a monoamine oxidase inhibitor (MAO) within 14 days prior to baseline, or those with the potential need to use MAO inhibitor during the study or within 5 days of discontinuation of investigational drug.
- •Participants who answer 'yes' to any of the questions about active suicidal ideation/intent/behaviors occurring within the past month (Columbia-Suicide Severity Rating Scale, suicide ideation section-questions 4 and 5; suicidal behaviors section).
- •Have a primary painful condition that may interfere with assessment of the index joint, i.e., knee.
- •Pregnant participants, female participants who wish to be pregnant during the clinical study period, or participants who are breast-feeding; or male participants who wish pregnancy of the partner.
- •Participants who cannot use appropriate contraceptive method or do not want to use that from the start of the study until one month after the end of administration of the investigational drug.
- •Considered as inappropriate participation to the study for any medical or other reason by the investigator.
研究组 & 干预措施
Duloxetine
Experimental
Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 48 weeks administered orally once daily. During tapering period, dose of 40 mg for one week and then 20 mg for the last week.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)
时间窗: Baseline through Week 53
A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.
次要结局
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50(Baseline, Week 50)
- Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 50)
- Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)(Baseline, Week 50)
- Percentage of Participants With Fall Events From Fall Questionnaire(Baseline through Week 50)
- Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument(Baseline, Week 50)
- Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score(Baseline, Week 50)
- Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score(Baseline, Week 50)
- Patient Global Impression-Improvement (PGI-I) at 50 Weeks(Week 50)
研究者
研究点 (1)
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