CTRI/2023/11/059740招募中3 期
A phase III randomized, double blinded, double dummy, parallel group, placebo controlled, two arm, multicenter clinical study to evaluate the safety and efficacy of Pregabalin Gel 8 % w/w in comparison with Pregabalin Capsule as a standard of care in patients with diabetic neuropathic pain. - NI
yka Labs Limited0 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
- 招募中
- 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.Patients of either gender between 18 to 75 years (both inclusive).
- •2.Diagnosis of chronic diabetic neuropathic pain restricted only to feet area by investigator before at least 1 month of screening.
- •3.Patient having daily pain in lower extremity in one or both the legs.
- •4.Patients having pain score greater than or equal to 4 on Visual Analogue Scale (VAS) of 0-10 at the time of screening and on day of enrolment (after washout period of seven days).
- •5.Score of 12 or more on Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score
- •6.HbA1c concentration should be less than 12.2 % at screening.
- •7.Provides written informed consent in accordance with applicable regulatory requirements.
排除标准
- •1.Proliferative retinopathy or maculopathy requiring acute treatment.
- •2.Requiring dialysis.
- •3.Impaired liver function
- •4.Vitamin B12 level below 180 ng/L or uncontrolled hypothyroidism in spite of adequate treatment.
- •5.Patients with any orthopedic alteration of any extremity.
- •6.Patients with peripheral artery disease.
- •7.Patients taking more than two diabetic neuropathic pain medicines
- •8.Patients who are receiving treatment with anti-depressants, antiepileptics
- •9.Patients with uncontrolled Angle-closure glaucoma.
- •10.A coexisting disorder causing pain as severe as the diabetic neuropathic pain.
- •11.Women of childbearing potential not receiving an effective form of contraception.
- •12.Pregnant woman or lactating mother.
- •13.Known hypersensitivity to Pregabalin, or any of its ingredients.
- •14.Patient who requires treatment with a drug that prolongs QT interval such as Cardiac medications like Antiarrhythmic drugs Class Ia (Quinidine, Procainamide, Disopromide), Class III (Dofetilide, Ibutilide, Sotalol) Non-cardiac medications like Antihistamines (Terfenadine, Astemizole), Antipsychotic and antidepressant agents, Neuroleptic (Haloperidol, Droperidol, Thioridazine, Chlorpromazine), Atypical antipsychotics (Sertindole, Ziprasidone, Risperidone, Zimeldine, Citalopram), Antidepressants (Amitriptyline, Desipramine, Imipramine, Maprotiline, Doxepin, Fluoxetin)Antibiotics like Quinolone (Sparfloxacin, Levofloxacin, moxifloxacin, grepafloxacin) and Macrolide (Erythromycin, Clarithromycin) Antimalarials (Quinine, halofantrine) Antiprotozoal(Pentamidine)Antifungal (Azole group) Antimotility Agents (Cisapride) Methadone
- •15.Creatinine clearance = 60 ml/min or known case of renal impairment.
- •16.Clinically significant laboratory abnormalities at the time of screening.
- •17.Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week.
- •18.Patients participated in any type of clinical study within the last 30 days of the screening date.
- •19.Unsuitability for enrollment otherwise as decided by investigator.
研究者
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