A phase III double blind multicenter randomized prospective parallel group study to evaluate the efficacy and safety of test product fixed dose combination of Gabapentin 200 mg and Duloxetine 20 mg capsule and test product fixed dose combination of Gabapentin 300 mg and Duloxetine 30 mg capsule manufactured by Synokem Pharmaceuticals Limited New Delhi India when compared with the reference product fixed dose combination of Pregabalin 75 mg and Duloxetine 30 mg capsule in treatment of neuropathic pain
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 4
- 主要终点
- Mean change in Pain Intensity as assessed by VAS
研究概览
简要总结
This is a prospective, randomized, Double-Blind, multi center, parallel group, Active-controlled, Phase III study to evaluate the efficacy and safety of Test Product (T1) Fixed Dose Combination of Gabapentin 200 mg + Duloxetine 20 mg capsule & Test Product (T2) Fixed Dose Combination of Gabapentin 300 mg + Duloxetine 30 mg capsule manufactured by Synokem Pharmaceuticals Ltd, New Delhi, India and Reference Product (R) Fixed Dose Combination of Pregabalin 75 mg + Duloxetine 30 mg capsule in Treatment of Neuropathic Pain.â€
Study Objectives:
Primary Objective: To evaluate the efficacy of test product (T1) Fixed Dose Combination of Gabapentin 200mg + Duloxetine 20mg capsule & test product (T2) Test Product (T2) Fixed Dose Combination of Gabapentin 300mg + Duloxetine 30mg capsule and Reference Product (R) Fixed Dose Combination of Pregabalin 75mg + Duloxetine 30mg capsule in patients with painful neuropathy in terms of Visual Analogue Scale (VAS)
Secondary Objective:To evaluate the Safety of test product (T1) Fixed Dose Combination of Gabapentin 200 mg + Duloxetine 20mg capsule & Test Product (T2) Fixed Dose Combination of Gabapentin 300mg + Duloxetine 30mg capsule and Reference Product (R) Fixed Dose Combination of Pregabalin 75mg + Duloxetine 30mg capsule in patients with painful neuropathy in terms of Visual Analogue Scale (VAS).
Primary Endpoint:
- Mean change in Pain Intensity as assessed by VAS. Time Frame: Baseline to EOT/EOS.
Secondary Endpoint:
-
Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS.
-
Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pinprick) as assessed by VAS.
-
Pain disability index score. Time Frame: Baseline to EOT/EOS.
-
By the type, number, frequency and proportion of patients with Adverse Event(s).
Study Population: 210 patients
Study Duration: 56 Days
Number of Visit: 04
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 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female patients with age more than 18 years.
- •Written informed consent signed by patient and willing to comply with the study procedure.
- •Patients with established newly diagnosis of Neuropathic pain (e.g., Post herpetic neuralgia, Diabetic neuropathy, post-surgical/ traumatic neuropathic pain.).
- •Presence of dynamic tactile allodynia or pinprick hyperalgesia in the area of pain.
- •Except Neuropathic pain and diseases associated with it patient is judged to be in general good health based on medical history and physical examination.
- •In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test
- •Patients having pain rating of at least 4 on a VAS of 0-10.
排除标准
- •Patients with age less than 18 years.
- •Pregnant and lactating women patients.
- •Women of childbearing potential who are not willing to use effective contraception during the study and not willing to undergo pregnancy test.
- •Patients not willing to comply with the study protocol and provide written informed consent to participate.
- •Participation in a clinical trial with an investigational product within 90 days preceding day one of this study.
- •Patients with known history of cardiac failure, orthostatic hypotension, narrow angle glaucoma, renal and liver impairment or any other condition that in the judgment of the investigator not suitable to be enrolled in the study.
- •Patients having history of any other type of pain as severe as the pain under study.
- •Patients having history of any other type of Neuropathic pain not included in the study.
- •Patients having skin disease, breakdown, infection, or extreme thinning at the site of pain.
- •Patients with known hypersensitivity to Amitriptyline / Lidocaine / Capsaicin.
- •Patients with history of using topically applied Amitriptyline / Lidocaine / Capsaicin and corticosteroids on the painful area.
- •Concurrent class I antiarrhythmic drugs (eg, tocainide or mexiletine)
- •Patient with known alcohol or other substance abuse as per treating physician discretion within last one year from screening or patient who consume alcohol during the surveillance, which in the opinion of the investigator will impact patient’s treatment evaluation and safety during surveillance.
- •History of HIV, HBV, HCV
- •History of any acute/chronic stokes, heart failures and relevant cardiac diseases.
- •Hypercreativity of the study drug.
结局指标
主要结局
Mean change in Pain Intensity as assessed by VAS
时间窗: Baseline, Treatment Visit Week 4 and EOT or EOS Week 8
次要结局
- Mean change in Allodynia (pain due to a stimulus that does not normally cause pain, e.g., stroking) as assessed by VAS.(Baseline Treatment Visit Week 4 & EOT or EOS Week 8)
- Mean change in Hyperalgesia (severe pain due to a stimulus that normally causes slight pain, e.g., a pinprick) as assessed by VAS.
- Pain disability index score(Baseline Treatment Visit Week 4 & EOT or EOS Week 8)
- By the type, number, frequency & proportion of patients with Adverse Event(s).(Baseline Treatment Visit Week 4 & EOT or EOS Week 8)
研究者
Dr Neel Lahoti
Synergen Bio Private Limited