NCT00483730已完成3 期
A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Clinical Trial to Evaluate Efficacy and Safety of Actovegin® in Diabetic Type 2 Patients With Symptomatic Diabetic Peripheral Polyneuropathy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 569
- 试验地点
- 2
- 主要终点
- TSSaverage: Average of the TSS over the treatment period (AUC / exposure time) VPTaverage: Average of the VPT measurement over the treatment period (AUC / exposure time)
研究概览
简要总结
To assess clinical efficacy and safety of Actovegin in type 2 diabetic patients with symptomatic diabetic peripheral polyneuropathy after 250 ml i.v. infusions once daily for 20 days followed by oral treatment 600 mg × 3 daily for 140 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The medical condition / disease to be studied is symptomatic diabetic peripheral polyneuropathy.
- •All inclusion criteria must be answered "yes" for a patient to participate in the trial.
- •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.
- •Is the patient aged ≥ 18 to ≤ 65 years?
- •Does the patient suffer from type 2 diabetes mellitus?
- •Has the patient evidence of symptomatic diabetic peripheral polyneuropathy, i.e. TSS ≥ 6 and NIS-LL ≥ 2?
- •Is the patient's VPT measured to ≤ 30V?
- •Has the patient adequate circulation to the foot as evidenced by a palpable pulse on posterior tibialis artery and dorsal artery of foot?
- •Is the HbA1C level less than 10%?
- •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:
- •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):
- •Does the patient use an acceptable contraceptive method (hormonal pills, patches, implants, injections or intrauterine device)?
- •Is the pregnancy test negative before the 1st dose of trial medication?
- •(Surgically hysterectomised and surgically successfully sterilized females may be included on the same conditions as male patients).
排除标准
- •All exclusion criteria must be answered "no" for a patient to participate in the trial.
- •Does the patient suffer from known allergy towards Actovegin or similar preparations?
- •Has the patient asymmetrical neuropathy of the trunk or proximal lower limbs?
- •Does the patient suffer from diabetic foot ulceration or infections?
- •Does the patient suffer from diabetic amyotrophy?
- •Does the patient suffer from decompensated cardiac insufficiency, pulmonary oedema, oliguria, anuria, generalised oedema?
- •Does the patient suffer from polyneuropathy due to other underlying causes?
- •Has the patient been hospitalised due to diabetic polyneuropathy within the last month?
- •Has the patient participated in any other trial with an Investigational Medicinal Product (IMP) or device within 30 days before inclusion in this trial?
- •Has the patient ever used medications that may be etiological factors for neuropathy, such as isoniazid, nitrofurantoin, vincristine and phenytoin?
- •Has the patient used cerebrolysin or α-lipoic acid or received Transcutaneous Electric Nerve Stimulation (TENS) or acupuncture within the last month?
- •Has the patient received opiates as treatment of his / her diabetic polyneuropathy within the last month?
- •Does the patient suffer from any malignancy?
- •Is the patient nursing?
- •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?
- •Does the patient suffer from present and / or previous chronic alcohol abuse?
- •Is there any anamnestic evidence of hypothyroidism?
- •Is there any anamnestic evidence of vitamin B12 deficiency?
- •Does the patient suffer from an impaired renal function with high blood urea nitrogen (BUN) and / or increased serum creatinine (>120 µmol/L)?
结局指标
主要结局
TSSaverage: Average of the TSS over the treatment period (AUC / exposure time) VPTaverage: Average of the VPT measurement over the treatment period (AUC / exposure time)
时间窗: Approx. 5½ months
次要结局
- NIS-LLaverage: Average of the NIS-LL over the treatment period (AUC / exposure time)(Approx. 5½ months)
研究者
研究点 (2)
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