NCT02248480已完成3 期
Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan
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
- 354
- 试验地点
- 1
- 主要终点
- Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy of the study drug known as duloxetine in participants with chronic osteoarthritis (OA) and knee pain in Japan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participants with present OA.
- •Have pain for ≥ 14 days of each month for 3 months prior to study entry.
- •Participants must have a score of ≥4 on the BPI average pain score before randomization.
- •Females of child-bearing potential must test negative (-) on a pregnancy test.
排除标准
- •Participants who cannot appropriately complete the daily diaries.
- •Have a score change of ≧3 on BPI 24-hour average pain score between screening and baseline.
- •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 who have serum creatinine level higher than 2.0 mg/dL, or had renal transplantation or are 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 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 uncorrected thyroid disease, uncontrolled narrow-angle glaucoma, history of uncontrolled seizures, or uncontrolled or poorly controlled hypertension.
- •Participants who have received intrarticular hyaluronate or steroids, joint lavage, or other invasive therapies to the knee in the past 1 month.
- •Participants who have had knee arthroscopy of the index knee within the past year or joint replacement of the index knee or osteotomy at anytime.
- •Participants who have end-stage osteoarthritis or surgery planned during the trial for the index joint.
- •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 taking any excluded medications that cannot be discontinued.
- •Participants anticipated by the investigator to require use of nonsteroidal anti-inflammatory drugs that include acetaminophen, opioid analgesics, or other excluded medication for the duration of the study.
- •Participants treated with a monoamine oxidase inhibitor (MAoI) 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).
- •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 primary painful condition that may interfere with assessment of the index joint, i.e., knee.
- •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 screening.
- •Have had previous exposure to duloxetine or completed/withdrawn from any study investigating duloxetine.
- •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.
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 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
干预措施: Duloxetine (Drug)
Placebo
Placebo Comparator
Placebo administered orally once a day for 15 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score
时间窗: Baseline, Week 14
Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.
次要结局
- Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)(Baseline, 14 Weeks)
- Change From Baseline on the Patient Global Assessment Illness (PGAI) Score(Baseline, Week 14)
- Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score(Baseline, Week 14)
- Change From Baseline on the Clinical Global Impression of Severity (CGI-S)(Baseline, Week 14)
- Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score(Baseline, Week 14)
- Change From Baseline on the WOMAC Questionnaire Stiffness Subscale(Baseline, 14 Weeks)
- Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 14)
- Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale(Baseline,Week 14)
- Change From Baseline on the WOMAC Questionnaire Pain Subscale(Baseline, 14 Weeks)
- Change From Baseline on the WOMAC Questionnaire Physical Function Subscale(Baseline, 14 Weeks)
- Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score(Baseline, Week 14)
- Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument(Baseline, Week 14)
- Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score(Baseline, Week 14)
- Percentage of Participants With Fall Events From Fall Questionnaire(Baseline through Week 14)
- Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score(Baseline, Week 14)
- Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria(Baseline, Week 14)
研究者
研究点 (1)
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