A Randomised, Multiple-dose, Multicentre, Three- Arm, Parallel Study to Compare the Efficacy and Safety of Pregabalin ER Tablet of Alvogen Malta (Out-Licensing) Ltd. to Placebo and Lyrica® (Pregabalin) Hard Capsule of Pfizer in Subjects with Peripheral Neuropathic Pain.

Alvogen Malta OutLicensing Ltd0 个研究点目标入组 453 人开始时间: 待定最近更新: 2024年1月22日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 453

研究概览入排标准研究者记录与标识符相似试验

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/or non-pregnant or non-lactating female subject = 18 years of age or above. Subject with any one of the following conditions during first visit:
•2.For PHN (Post herpatic neuralgia): Subject must have pain for more than 3 months after healing of the herpes zoster skin rash.
•3.For DPN (diabetic peripheral neuropathy): Subject should have a history of diabetes mellitus (Type I or Type II) and painful, sensorimotor polyneuropathy for = 6 months.
•4.At screening visit and baseline visit, subject must have a score of = 4 on the pain NRS scale (1-week recall period).
•5.At baseline visit, at least 4 pain diary entries must be completed within the last 7 days and the average pain score must be = 4.
•6.Subject with a creatinine clearance of at least 60 mL/min (estimated from serum creatinine).
•7.Subject who agrees not to use any other approved or experimental pharmacological treatments for neuropathic pain at any time during the study.
•8.Subject able to understand the investigational nature of this study and give written informed consent prior to study entry.
•9.Able to comply with study requirements in the opinion of investigator.
•10.Female subject of childbearing potential must have a confirmed negative pregnancy test prior to enrolment.
•11.Male or female of childbearing potential must be willing to use adequate methods of contraception throughout the study.
•12.Subject with a history of depression that is in remission, with or without antidepressant treatment, can participate, unless a stable antidepressant regimen includes a prohibited medication.
•Note: Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least three months prior to the start of the baseline period. Condition of depression will be evaluated by investigator in consultation with psychiatrist.

排除标准

•1.Female who are breastfeeding, pregnant or planning to become pregnant.
•2.History of hypersensitivity or allergy to pregabalin, or other a2d ligands (e.g. gabapentin) or any of the study medication ingredients.
•3.Skin conditions in the affected dermatome that could alter sensation.
•4.Meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) for a major depressive episode or for active CNS disorders within a year prior to screening visit, including dementia, psychosis, seizure, post-traumatic stress disorder or bipolar disorder.
•5.Nerve block or acupuncture or special procedures (e.g. TENS) for the relief of pain performed 4 weeks prior to the baseline visit and throughout the duration of the study.
•6.Subject with known intolerance or refractory to pregabalin.
•7.Use of prohibited medications in the absence of appropriate washout periods.
•8.Subject with suicidal ideation (score of 4 or 5 on the Columbia Suicide Severity Rating Scale [C-SSRS]) within the past 2 months or any suicidal behaviour occurring in the past year.
•9.Pregabalin use in the last 30 days prior to screening visit. Subject taking pregabalin should undergo wash out of pregabalin for at least 30 days prior to the screening visit.
•10.Subject with a history of life-threatening neoplasms within 5 years prior to screening visit, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
•11.Subject with difficulty in swallowing or unable to tolerate oral medication.
•12.Subject with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication.
•13.Subject who has taken neurolytic or neurosurgical therapy for neuropathic pain.
•14.Subject suffering with other types of neuropathic pain.
•15.Subject with history of chronic obstructive pulmonary disease (COPD), asthma or respiratory depression disorder.
•16.Presence of severe pain associated with conditions other than study indication that could confound the assessment or self-evaluation of neuropathic pain, examples, amputation other than toes, psychiatric disorders, non-diabetic neurologic disorders, and skin conditions affecting sensation in painful limbs.
•17.Subject with a history of angle-closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension (systolic BP = 150 mmHg/diastolic BP = 100 mmHg) or clinically significant ECG abnormality or the participant has any other abnormal laboratory value of clinical significance for this study.
•18.Subject with HbA1c = 10 % at screening visit.
•19.Subject with known alcohol or other substance abuse within the last one year.
•20.Subject associated with profession of driving or operating heavy machineries.
•21.Subject participated in any other clinical study using investigational drug in past 30 days before the date of screening visit.
•22.Institutionalised subject.
•23.Live in the same household as currently enrolled subject.
•24.Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into the trial. <br/

研究者

发起方

Alvogen Malta OutLicensing Ltd

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