An Open Label, Randomized, 3 Arm, Multicentric, Prospective Clinical Study to assess theEfficacy, Safety and Tolerability of Fixed Dose Combination of Gabapentin 400mg andNortriptyline HCl 10mg Vs Gabapentin 400mg Vs Nortriptyline HCl 10mg in Adultpatients with Peripheral Neuropathy with or without association of Diabetes Mellitus.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Primary Endpoint:
研究概览
简要总结
Peripheral Nerve Disorders (Peripheral neuropathy)
Peripheral neuropathy is a common problem and for some patients, pain is a disabling component of the neuropathy. The first goal in evaluating patients with painful peripheral neuropathies is to identify the cause, with the hope of identifying treatment to reverse nerve damage. When neuropathic pain is present, it is appropriate to treat this concurrently, during the evaluation, as well as during the treatment of the neuropathy, if identified is in process.
For some types of neuropathy, there are no available treatments for the underlying disorder, and therapy for neuropathic pain, if present may be the only treatment available.
INVESTIGATIONAL PRODUCT (S)
GABAPENTIN
Gabapentin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. Gabapentin is used in adults to treat nerve pain caused by herpes virus or shingles (herpes zoster) and to treat restless legs syndrome (RLS). Gabapentin is also used to treat seizures in adults and children who are at least 3 years old.
Role of Gabapentin:
The mechanism of action of gabapentin remains unknown. Evidence suggests that it is most likely to be the result of a complex synergy between increased GABA synthesis, non-NMDA receptor antagonism and binding to the a2d subunit of voltage dependent calcium channels. The latter action inhibits the release of excitatory neurotransmitters. Although it was expected to act as a GABA agonist, gabapentin does not act directly on GABA receptors,
nor does it influence the reuptake of GABA. It does increase the synthesis of GABA from glutamate and enhances its release from astrocytes.
Nortriptyline is a tricyclic antidepressant. It affects chemicals in the brain that may become unbalanced. Nortriptyline is used to treat symptoms of depression.
It is believed that nortriptyline either inhibits the reuptake of the neurotransmitter serotonin at the neuronal membrane or acts at beta-adrenergic receptors. Tricyclic antidepressants do not inhibit monoamine oxidase nor do they affect dopamine reuptake. Nortriptyline is a metabolite of amitriptyline and reportedly blocks norepinephrine, serotonin uptake, sodium channels, thus reduces transmission of pain sensation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women of at least 18 years of age willing to give informed consent for the study.
- •Patients diagnosed with peripheral neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).
- •Patients with peripheral neuropathy associated with diabetes that is stable and controlled (HbA1C ≤ than 10 %) with no new symptoms associated with diabetes within previous 3 months.
- •Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration 5) Patients on pain medication (prescribed analgesics), stable for atleast 3 months before study entry or pain treatment naive.
- •Patients having Toronto Clinical Neuropathy Score (TCNS) ≥ 6 at screening/ baseline visit(Day 1/ Week 0).
排除标准
- •Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control.
- •Escalating or changing pain condition within the past month as evidenced by investigator examination.
- •Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days.
- •Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months.
- •Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump.
- •Subjects currently has an active infection.
- •Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates participation in this clinical trial.
- •Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator.
结局指标
主要结局
Primary Endpoint:
时间窗: 24 weeks
b) Change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS) at week 0 (Visit 2) and week 24.
时间窗: 24 weeks
a) Change from baseline in peroneal motor nerve conduction velocity at week 0 (Visit 1) and week 24.
时间窗: 24 weeks
次要结局
- Secondary Endpoints:(a) Change from baseline in quality of life administered by SF-36 Questionnaire instrument at week 0 (Visit 2), Week 12 and week 24 (Patient global impression of quality of life assessed by the SF-36)