Effect of Duloxetine 60mg Once Daily in Patients With Chronic Pain Due to Osteoarthritis in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of duloxetine once daily compared with placebo on the reduction of pain due to osteoarthritis (OA) in knee or hip in participants in China.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet clinical and radiographic criteria for the diagnosis of OA of the knee or hip with pain for ≥14 days of each month for 3 months prior to study entry
- •Have a rating ≥4 on the Brief Pain Inventory (BPI) 24-hour average pain item (Question 3 of the BPI modified short form) at both Screening and Randomization
排除标准
- •Have previously completed/withdrawn from this study or any other study investigating duloxetine (Note: Participants who have been previously screened for a duloxetine study other than this study and never received investigational product will be eligible for this study if they meet all current entry criteria)
- •Have had previous exposure to duloxetine
- •Have any previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
- •Current (within 1 year of Screening) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I diagnosis of major depressive disorder, anxiety disorders (excluding phobias), alcohol or eating disorders, as determined by the Mini-International Neuropsychiatric Interview or a previous diagnosis
- •Have a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
- •Are taking any excluded medications that cannot be discontinued at Screening
- •Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
- •Have a positive urine drug screen for any substance of abuse or excluded medication
- •Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study
- •Have a history of recurrent seizures other than febrile seizures
- •Are judged clinically by the investigator to be at suicidal risk according to the Columbia - Suicide Severity Rating Scale (C-SSRS): a "Yes" answer to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the"Suicidal Ideation" portion of the C-SSRS or a "Yes" answer to any of the suicide related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the C-SSRS, with the ideation/behavior having occurred within the previous month
- •Have uncontrolled narrow-angle glaucoma
- •Have acute liver injury (such as hepatitis) or severe cirrhosis
- •Have known hypersensitivity to duloxetine or any of the inactive ingredients or have frequent/severe allergic reactions to multiple medications
- •Have frequent falls that could result in hospitalization or could compromise response to treatment
- •Have a diagnosis of inflammatory arthritis [that is, rheumatoid arthritis (RA)] or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis)
- •Have received intra-articular hyaluronate/steroids, joint lavage, or other invasive therapies to the index joint in the previous 3 months
- •Have had arthroscopy of the index joint within the previous year or joint replacement of the index joint at any time
- •Have surgery of the index joint scheduled to occur during the trial or are anticipated by the investigator to require surgery for the treatment of the OA of the index hip or knee along the duration of the study
- •Have had a prior synovial fluid analysis showing a white blood cell (WBC) count ≥2000 cubic millimeter (mm3) that is indicative of a diagnosis other than OA
- •Are non-ambulatory or require the use of crutches or a walker
- •Have a body mass index >40
- •Are anticipated by the investigator to require use of analgesic agents including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study
研究组 & 干预措施
Duloxetine
Double Blind Treatment Phase:
60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks.
Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
干预措施: Duloxetine (Drug)
Placebo
Double Blind Treatment Phase:
Placebo administered by mouth once a day (QD) for 13 weeks.
Extension Treatment Phase:
60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score
时间窗: Baseline, Week 13
BPI is a self-reported scale that measures the severity of pain based on the average pain 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 mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
次要结局
- Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores(Baseline, Week 13)
- Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)(Baseline, Week 13)
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score(Baseline,13 Weeks)
- Change From Baseline in Brief Pain Inventory (BPI) Severity(Baseline, Week 13)
- Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score(Week 13)
- Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint(Week 13)
- Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores(Baseline, Week 13)
- Change From Baseline in Brief Pain Inventory (BPI) Interference(Baseline, Week 13)
- Patient Global Impressions of Improvement (PGI-I) Score(13 Weeks)