CTRI/2018/02/011976尚未招募4 期
A Double Blind, Double-Dummy, Randomized, Prospective, Two Arm, Parallel, Multicenter, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Gabapin NT (Fixed-Dose Combination of Gabapentin and Nortriptyline) in Comparison with Gabapentin in Patients with Neuropathic Pain
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1 Patients of either gender between 18 and 65 years (both inclusive).
- •2 Diagnosis of chronic neuropathic pain by investigator before at least 3 months of screening
- •3 Patient having daily pain score greater than or equal to 4 on Numeric Rating Scale (NRS) of 0-10 at the time of screening and on day of enrolment (after washout period).
- •4 Score of 12 or more on Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score
- •5 Patients have at least two of the following non-specific symptoms: allodynia (pain from a non-noxious stimulus, e.g. touch), burning
- •pain, shooting pain, or hyperalgesia (increased sensitivity to a noxious stimulus) at the time of screening.
- •6 Provides written informed consent in accordance with applicable regulatory requirements
排除标准
- •1 Any major organ system disease, cardiovascular autonomic neuropathy, sedation or ataxia due to concomitant drugs or other
- •2 Urinary symptoms attributable to benign prostatic hypertrophy in male participants.
- •3 Vitamin B12 level below 180 ng/L or uncontrolled hypothyroidism in spite of adequate treatment
- •4 Patients with any orthopaedic alteration of any extremity
- •5 Patients with peripheral artery disease
- •6 Patients taking more than two neuropathic pain medicines
- •7 Presence of a seizure disorder.
- •8 Patients who are receiving treatment with anti-depressants, antiepileptics
- •9 Patients with uncontrolled Angle-closure glaucoma.
- •10 Haemoglobin A1c concentration more than 13% at screening
- •11 Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist.
- •12 A coexisting disorder causing pain as severe as the neuropathic pain.
- •13 Women of childbearing potential not receiving an effective form of contraception.
- •14 Pregnant woman or lactating mother.
- •15 Known hypersensitivity to gabapentin, nortriptyline or any of its ingredients.
- •16 Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g., carbamazepine, oxcarbazepine).
- •17 Patient who require treatment with a drug that prolongs QT interval.
- •18 Creatinine clearance <= 60 ml/min or known case of renal impairment.
- •19 Clinically significant laboratory abnormalities at the time of screening.
- •20 Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances (other than Benzodiazepine).
- •21 Patients participated in any type of clinical study within the last 30 days of the screening date.
- •22 Unsuitability for enrollment otherwise as decided by investigator.
研究者
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