A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Gabapentin SR plus Methylcobalamin plus Nortriptyline film-coated bilayered tablets Versus FDC of Gabapentin SR Plus Methylcobalamin film-coated tablets in patients with peripheral neuropathic pain with coexistent Vitamin B12 deficiency.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 207
- 试验地点
- 10
- 主要终点
- Change in Pain Intensity Numerical Rating Scale (PI-NRS) from baseline to end of the study (8 weeks).
研究概览
简要总结
Combining Pregabalin or Gabapentin with TCAs or SNRIs is a treatment option for patients who cannot tolerate high-dose monotherapy. This approach is beneficial as many patients have insufficient pain relief on monotherapy with current drugs, which often have severe side effects and tolerability issues. Lower-dose combination therapies with different mechanisms of action, such as a moderate dose of a drug reducing calcium influx and a low dose of a drug inhibiting the tricyclic antidepressant, can be beneficial in pain medicine. Nortriptyline, a major metabolite of Amitriptyline, is less sedating and better tolerated than Amitriptyline, and can improve nephropathic pain. The study involves combination of Gabapentin SR 300/600 mg + Methylcobalamin 1500/1500 mcg + Nortriptyline 10/10 mg film-coated bilayered tablets or FDC of Gabapentin SR 600 mg + Methylcobalamin 1500 mcg + Nortriptyline 10 mg film coated bilayered tablets or FDC of Gabapentin SR 600 mg + Methylcobalamin 1500 mcg film coated Tablets. The medication is taken orally One tablet every night before sleep for 56 days. The duration of study will last for 8 weeks with study timeline 56±2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •The study aims to evaluate patients aged 18-75 with neuropathic pain, Gabapentin and Methylcobalamin treatment, decreased Vitamin B12 levels, and non-specific symptoms like allodynia, burning, shooting, or hyperalgesia.
- •Participants must sign an informed consent document and adhere to all protocol procedures.
排除标准
- •Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •Patients using gabapentin for any other neurologic disorders unrelated to peripheral neuropathic pain.
- •Patient taking any other medication for the treatment of peripheral neuropathic pain last two weeks.
- •Patients with a diagnosis of type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) >11%.
- •Patients with abnormal eGFR (<60 mL/min/1.73 m2).
- •Patients with clinically significant impaired hepatic function.
- •[SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
- •Any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
- •Ongoing administration of Monoamine Oxidase (MAO) inhibitors.
- •Patients with medical history of Oncological Conditions.
- •Patients who, in the opinion of the investigator, have history of clinically significant cardiovascular disease (e.g. MI), central nervous system disorders (e.g. seizure, bipolar disorder, generalized anxiety disorder, untreated depression, psychosis or post-traumatic stress disorder), suicidal behavior, angle closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension.
- •Patients with known cases of HIV, Hepatitis B & C.
- •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.
- •Pregnant woman or lactating mother.
- •Patients participated in any type of clinical study within the last 3 months of the screening date.
- •Patients with known alcohol abuse within last one year and dependency on narcotics, opioids, or any other addictive substances.
- •Patients with an inability to comply with the protocol requirements.
结局指标
主要结局
Change in Pain Intensity Numerical Rating Scale (PI-NRS) from baseline to end of the study (8 weeks).
时间窗: 8 weeks
次要结局
- Change in the Vitamin B12 levels from baseline to end of the study (8 weeks).(Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale from baseline to end of the study (8 weeks).)
研究者
Dr Vaishal Shah
Lifeline Hospital