CTRI/2024/01/062147招募中3 期
A Multicentric, Randomized, Double Blind, Double Dummy, Prospective, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of FDC of Pregabalin plus Methylcobalamin plus Duloxetine (Delayed Release) Capsules Versus FDC of Pregabalin plus Methylcobalamin plus Nortriptyline Tablets in Subjects with Diabetic Peripheral Neuropathic Pain Coexisting with Vitamin B12 Deficiency.
Ravenbhel Healthcare Pvt. Ltd.10 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年2月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- Mean change in visual analog scale (VAS) from baseline to end of the treatment. (12 weeks)
研究概览
简要总结
Neuropathic Pain (NP) is a common complication of diabetes, affecting 30-50% of patients. Management is challenging due to insufficient therapeutic options. Pregabalin is effective for NP relief, and a combination of Pregabalin or Gabapentin with TCAs or SNRIs is now recommended. Combination therapy using two drugs with different mechanisms of action is beneficial in pain medicine.
Pregabalin binds to calcium channels in the central nervous system, potentially modulating pain transmission by reducing calcium influx and inhibiting excitatory neurotransmitters.
The study involves subjects taking a combination of Pregabalin 75 mg plus Methylcobalamin 1500 mcg plus Nortriptyline 10 mg Tablet and Matching Placebo Capsule, either in the Test or Reference arm. The medication is taken orally every night before sleep. The study will last for 14 weeks, with the duration of the medication being 84 ± 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female subjects between 18 to 75 years of age (both inclusive).
- •2.Subjects with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤12% and having pain associated with diabetic peripheral neuropathy≥ 3 months.
- •3.Subjects with pain intensity ≥ 4 on 0-10 points of visual analog scale (VAS).
- •4.Subjects with decreased vitamin B12 levels (< 200 pg/mL) at screening visit.
- •5.Subjects who are willing to sign written informed consent for participation in the study.
- •6.Subjects willing to adhere to all protocol procedures.
排除标准
- •1.Subjects with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2.Patients with prior therapy with Pregabalin or Duloxetine or Nortriptyline and having any other neurologic disorders unrelated to diabetic peripheral neuropathic pain were excluded.
- •3.Patients with clinically significant impaired hepatic function.
- •[SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •4.Subject with abnormal eGFR (<60 mL/min/1.73 m2).
- •5.Subjects with Serum creatinine more than 1.5X the ULN.
- •6.Patients with any abnormality on 12 lead ECG readings and the results are deemed clinically significant by the investigator.
- •7.Subjects with a history of HIV, Hepatitis B & C.
- •8.Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •9.Females who are not ready to use acceptable contraceptive methods during the course of study.
- •10.Subjects who, in the opinion of the investigator, have a history of clinically significant cardiovascular disease (e.g. MI), subjects who are on pacemakers, central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension, bleeding disorders.
- •11.Subjects with history of suicidal thoughts and behavior.
- •13.Subjects with uncontrolled hypertension with sitting SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg at screening.
- •14.Patient treated with topical or systemic pain medications within past 2 weeks prior to baseline.
- •15.Subjects with known alcohol or other substance abuse.
- •16.Subjects with a medical history of Oncological Conditions.
- •17.Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
- •19.Participant has a clinically significant disorder that, in the opinion of the investigator, would result in the participant’s inability to understand and comply with the requirements of the study.
结局指标
主要结局
Mean change in visual analog scale (VAS) from baseline to end of the treatment. (12 weeks)
时间窗: 12 weeks
次要结局
- Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of treatment. (12 weeks).(Change in the Patient global impression of change scores (PGIC) from baseline to end of the treatment. (12 Weeks).)
研究者
研究点 (10)
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