A Phase 1b Study to Characterize the Effect of Injection Site Cooling on Pain Experienced After CNTX-4975-05 (Trans-capsaicin) Intra-articular and Capsaicin Intradermal Injections in Healthy Volunteers and Subjects With Bilateral Painful Knee Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating Scale (NPRS): Injection-site Pain
研究概览
简要总结
A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is aged between 18 and 45 years, inclusive.
- •Subjects Body Mass Index (BMI) is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
- •Subjects must be in good health, in the opinion of the Investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ECG).
- •Cohort 1 Key
排除标准
- •Subject has had a clinically significant illness that has not completely resolved in the four weeks before screening.
- •Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
- •Cohorts 2-4 Key Inclusion Criteria:
- •Subject is aged between 45 and 75 years, inclusive.
- •Subject's BMI is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
- •Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9, inclusive NPRS 0-10). The condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study.
- •Cohorts 2-4 Key Exclusion Criteria:
- •Subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening.
- •Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
- •Subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed.
- •Subject has used topical medications applied to the knee for OA pain (including capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening through to dosing.
- •Subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing.
- •Subject currently uses opioids for any condition other than OA knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).
研究组 & 干预措施
Cohort 1
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
干预措施: Ice Pack and Cooling Device (Other)
Cohort 1
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
干预措施: Capsaicin (Drug)
Cohort 3
Controlled cooling parameters will be determined after evaluation of data from prior cohorts.
干预措施: Capsaicin (Drug)
Cohort 2
Controlled cooling wrap versus ice pack cooling.
干预措施: CNTX-4975-05 (trans-capsaicin) (Drug)
Cohort 2
Controlled cooling wrap versus ice pack cooling.
干预措施: Capsaicin (Drug)
Cohort 3
Controlled cooling parameters will be determined after evaluation of data from prior cohorts.
干预措施: CNTX-4975-05 (trans-capsaicin) (Drug)
Cohort 4
Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
干预措施: CNTX-4975-05 (trans-capsaicin) (Drug)
Cohort 4
Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
干预措施: Capsaicin (Drug)
结局指标
主要结局
Numerical Pain Rating Scale (NPRS): Injection-site Pain
时间窗: Days 1 and 7
Cohorts 2-4: Change in injection-site pain following intra-articular (IA) administration of CNTX-4975-05 (trans-capsaicin) scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
次要结局
- IA Temperature(Days 1 and 7)
- Numerical Pain Rating Scale (NPRS): Procedural Pain(Days 1 and 7)
- Numerical Pain Rating Scale (NPRS): Pain with Walking(Screening through Day 42)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Screening through Day 42)
- Patient Global Impression of Change (PGIC)(Screening through Day 42)
- Numerical Pain Rating Scale (NPRS): Thermal Pain(Between Days 28 and 35 inclusive; and Day 42)