EUCTR2006-004007-19-AT进行中（未招募）不适用
A multi-centre, double-blind, placebo-controlled, randomised, parallel groupclinical trial to evaluate efficacy and safety of Actovegin® in diabetic type 2patients with symptomatic diabetic peripheral polyneuropathy - Actovegin® versus placebo in patients with diabetic polyneuropathy
ycomed Austria GmbH0 个研究点目标入组 550 人开始时间: 2006年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has the patient given informed consent according to local requirements before any trial related activities? A trial related activity is any procedure that would not have been performed during the routine management of the patient.
- •2. Is the patient aged = 18 to = 65 years?
- •3. Does the patient suffer from type 2 diabetes mellitus?
- •4. Has the patient evidence of symptomatic diabetic peripheral polyneuropathy, i.e. TSS =6 and NIS-LL = 2?
- •5. Is the patient’s VPT measured to = 30V?
- •6. Has the patient adequate circulation to the foot as evidenced by a palpable pulse on posterior tibialis artery and dorsal artery of foot?
- •7. Is the HbA1C level less than 10%?
- •8. Is the patient able to make frequent clinic visits over the trial period?
- •For patients receiving tricyclic antidepressants, anticonvulsants, mexiletine or neuroleptics as treatment of neuropathic pain:
- •9. Has the regimen been stable within the last month?
- •For female patients of childbearing potential (childbearing potential is considered until menopause has lasted more than 12 months):
- •10. Does the patient use an acceptable contraceptive method (hormonal pills, patches, implants, injections or intrauterine device)?
- •11. Is the pregnancy test negative before the 1st dose of IMP?
- •(Surgically hysterectomised and surgically successfully sterilized females may be included on the same conditions as male patients).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Does the patient suffer from known allergy towards Actovegin or similar preparations?
- •2. Has the patient asymmetrical neuropathy of the trunk or proximal lower limbs?
- •3. Does the patient suffer from diabetic foot ulceration or infections?
- •4. Does the patient suffer from diabetic amyotrophy?
- •5. Does the patient suffer from decompensated cardiac insufficiency, pulmonary oedema, oliguria, anuria, generalised oedema?
- •6. Does the patient suffer from polyneuropathy due to other underlying causes?
- •7. Has the patient been hospitalised due to diabetic polyneuropathy within the last month?
- •8. Has the patient participated in any other trial with an Investigational Medicinal Product (IMP) or device within 30 days before inclusion in this trial?
- •9. Has the patient ever used medications that may be etiological factors for neuropathy, such as isoniazid, nitrofurantoin, vincristine and phenytoin?
- •10. Has the patient used cerebrolysin or a-lipoic acid or received Transcutaneous Electric Nerve Stimulation (TENS) or acupuncture within the last month?
- •11. Has the patient received opiates as treatment of his / her diabetic polyneuropathy within the last month?
- •12. Does the patient suffer from any malignancy?
- •13. Is the patient nursing?
- •14. Does the patient suffer from any mental, psychiatric or other conditions that may
- •compromise data collection and understanding of written and verbal information given in the trial?
- •15. Does the patient suffer from present and / or previous chronic alcohol abuse?
- •16. Is there any anamnestic evidence of hypothyroidism?
- •17. Is there any anamnestic evidence of vitamin B12 deficiency?
- •18. Does the patient suffer from an impaired renal function with high blood urea nitrogen (BUN) and / or increased serum creatinine (>120 µmol/L)?
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