NCT02644421已完成1 期
Phase Ib Randomized, Double-Blind, Latin Square Crossover, Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 v. Lidocaine v. Placebo in Lumbar Radiculopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of subjects with treatment-related Adverse Events as assessed using an internal, categorical severity/relationship scale
研究概览
简要总结
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (>16-hours. Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a history of persistent pain secondary to unilateral monoradiculopathy present for a minimum of 3 months prior to the study, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
- •Males or females between 18 and 70 years of age, inclusive. Females who are pregnant or breastfeeding will be excluded from the trial.
- •Subjects must be in generally good health, either using no medication or using a stabilized medication regimen for chronic and well-controlled conditions such as hypertension, allergies, stable endocrinopathies (e.g. hypothyroidism), etc. Subjects with other active diseases will be reviewed on a case-by-case basis by the principal investigator.
- •No concomitant therapy with any medication that is a known significant inhibitor or inducer of CYP450 2D6 and CYP3A4, at the discretion of the PI.
- •Normal or clinically insignificant screening laboratory tests:
- •Serum BUN, creatinine, bicarbonate, calcium, chloride, potassium, sodium, lactate dehydrogenase, inorganic phosphate, total protein, glucose, albumin, and uric acid. WBC, absolute neutrophil count, hemoglobin, hematocrit, and platelets. SGOT (AST), SGPT (ALT), total bilirubin, alkaline phosphatase, TSH/T4, urinalysis, and urine toxicology screen.
- •Electrocardiogram (12-lead). Any significant laboratory abnormalities will be reviewed by the principal investigator prior to inclusion of the subject in the study.
- •Willingness to restrict analgesic therapy during inpatient admission days to the allowed rescue analgesic agent permitted by the study (acetaminophen).
- •Subjects must have normal cognitive function and communicative ability in the English language.
- •Subjects must be able to provide meaningful written informed consent.
- •Subjects must be able to maintain complete required questionnaires, and must be able to fulfill all other conditions of the protocol.
排除标准
- •Female subjects who are pregnant or breastfeeding, or plan to become pregnant while participating in the study.
- •Subjects with a previous history of multiple or severe drug allergies, including lidocaine.
- •Subjects with a history of or current chronic substance abuse, including alcohol.
- •Subjects who have participated in a study of an investigational drug or device within 30 days prior to screening for this study. Subjects must agree not to participate in other investigational drug or device studies during the entire course of this study (beginning with the screening visit).
- •Subjects with the following abnormal clinical evaluations:
- •Impaired renal function defined as BUN > 45 or creatinine >2.0 and/or impaired liver function defined as liver transaminases, alkaline phosphatase, or bilirubin greater than 1.5 x upper limit of normal laboratory values.
- •Prolonged PR (>200 ms) interval on electrocardiogram (12-lead). Subjects presenting with the above laboratory abnormalities may be allowed on a case-by-case basis at the discretion of the principal investigator.
- •Subjects who intend to donate blood or blood products while participating in this study, and for 30 days following completion of the study.
- •Subjects with clinically significant renal, hepatic, or cardiac disease, with seizure disorders, or with a clinical history of life-threatening arrhythmias (i.e. torsades de pointes).
- •Subjects with a severe neuropsychiatric disorder requiring treatment.
- •Subjects with sensitivity to amide-type local anesthetics.
研究组 & 干预措施
VVZ-149
Experimental
The following doses will be administered intravenously:
- Loading Dose: 1.8 mg/kg VVZ-149 over 0.5 hours
- Maintenance infusion: 1.3 mg/kg/hr VVZ-149 over 7.5 hours
干预措施: VVZ-149 (Drug)
Lidocaine
Active Comparator
The following doses will be administered intravenously:
- Lidocaine 4mg/kg LBM over 0.5 hours
- Normal saline over 7.5 hours
干预措施: Lidocaine (Drug)
Placebo
Placebo Comparator
Normal saline administered intravenously over 8 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with treatment-related Adverse Events as assessed using an internal, categorical severity/relationship scale
时间窗: over 8 hour infusion
The number of subjects who report mild, moderate or severe treatment-emergent adverse events that are deemed by the investigator to be possibly, probably, or definitely related to the study medication
次要结局
- Reduction in Pain Intensity using the 11-pt Likert Pain Intensity Scale(over 8 hour infusion)
研究者
Christine N. Sang, MD, MPH
Director, Translational Pain Research
Brigham and Women's Hospital
研究点 (1)
Loading locations...
相似试验
招募中
3 期
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With ColchicineCardiomyopathiesInflammatory CardiomyopathyVentricular ArrythmiaHeart FailureMyocarditisNCT06158698Niguarda Hospital80
已完成
1 期
AT247, NovoRapid® and Fiasp® in Glucose Clamp StudyDiabetes Mellitus, Type 1NCT03959514Arecor Limited18
已完成
3 期
Constipation Associated With Irritable Bowel Syndrome (IBS-C)ConstipationNCT00796354Norgine210
进行中（未招募）
3 期
norUrsodeoxycholic Acid vs Placebo in PSCPrimary Sclerosing CholangitisNCT03872921Dr. Falk Pharma GmbH303
招募中
3 期
Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease2024-516198-61-00Unicancer1,080