CTRI/2024/07/071354尚未招募3 期
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 - NI
Mr Surender Arora0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and Female patients with age more than 18 years.
- •2. Written informed consent signed by patient and willing to comply with the study procedure.
- •3. Patients with established newly diagnosis of Neuropathic pain (e.g., Post herpetic neuralgia, Diabetic neuropathy, post-surgical/ traumatic neuropathic pain.).
- •4. Presence of dynamic tactile allodynia or pinprick hyperalgesia in the area of pain.
- •5. Except Neuropathic pain and diseases associated with it patient is judged to be in general good health based on medical history and physical examination.
- •6. In case of woman of childbearing potential willing to use effective contraception during the study and willing to undergo pregnancy test
- •7. Patients having pain rating of at least 4 on a VAS of 0-10.
排除标准
- •1. Patients with age less than 18 years.
- •2. Pregnant and lactating women patients.
- •3. Women of childbearing potential who are not willing to use effective contraception during the study and not willing to undergo pregnancy test.
- •4. Patients not willing to comply with the study protocol and provide written informed consent to participate.
- •5. Participation in a clinical trial with an investigational product within 90 days preceding day one of this study.
- •6. 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.
- •7. Patients having history of any other type of pain as severe as the pain under study.
- •8. Patients having history of any other type of Neuropathic pain not included in the study.
- •9. Patients having skin disease, breakdown, infection, or extreme thinning at the site of pain.
- •10. Patients with known hypersensitivity to Amitriptyline / Lidocaine / Capsaicin.
- •11. Patients with history of using topically applied Amitriptyline / Lidocaine / Capsaicin and corticosteroids on the painful area.
- •12. Concurrent class I antiarrhythmic drugs (eg, tocainide or mexiletine)
- •13. 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.
- •14. History of HIV, HBV, HCV
- •15. History of any acute/chronic stokes, heart failures and relevant cardiac diseases.
- •16. Hypercreativity of the study drug.
- •17. Patients already using any other medication for pain relief like PCM/ NSAIDS /opioids etc.
研究者
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