National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change from baseline in pain intensity.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Participants of 18 years and older;
- •Diagnosis of type 2 or type 1 diabetes for at least 1 year;
- •No change in antidiabetic medication winthin 3 months;
- •Diagnosis of painful sensorimotor diabetic polyneuropathy;
- •Presence of at least one of the following symptoms: i. numbness in the toes, feet and / or legs; ii. paresthesias (tingling and / or neuropathic pain) in the toes, feet and / or legs.
- •Presence of at least one of the following signs: i. symmetrical hypoesthesia of tactile, thermal or painful sensation (s) in the distal region of the legs; ii. hypoactive or abolished achilles reflexes;
- •Glycated hemoglobin ≤ 11%;
- •Score ≥ 12 points on the LANSS pain scale (Leeds Assessment of Neuropathic Symptoms and Signs); j) Participants with moderate to severe pain, a score ≥ 4 on the numerical pain scale (0-10 points);
- •Participants with moderate to severe neuropathic pain who recorded in the diary a minimum of 4 of the 7 days from the period to assess the baseline pain score.
排除标准
- •Known hypersensitivity to the formula components used during the clinical trial;
- •History of alcohol and/or substance abuse within 2 years;
- •Pregnant women, breastfeeding or planning to become pregnant, or women with the potential to become pregnant who are not using a reliable method of contraception;
- •History of pernicious anemia, uncontrolled hypothyroidism, chronic hepatitis B;
- •HIV diagnosis;
- •History of neurological disorder unrelated to diabetic neuropathy;
- •Non-responders to previous pregabalin treatment;
- •High variability in the baseline pain score;
- •Other conditions that may alter the sensitivity in the affected dermatome or in the area involved in neuropathic pain that may confuse pain assessment;
- •Severe psychiatric condition;
- •Cognitive decline that affect the participant from correctly answering the scales and questionnaires;
- •Clinically relevant cardiac abnormalities, which at the researcher's discretion represent a risk to participation in the trial;
- •Participant who has amputated lower limb due to complications from diabetes;
- •Renal failure, defined by the estimated glomerular filtration rate [eGFR] <60 mL / min / 1.73 m2.
研究组 & 干预措施
Praga formulation
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral
干预措施: Placebo pregabalin 75mg (Other)
Praga formulation
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral
干预措施: Placebo Pregabalin 150mg (Other)
Praga formulation
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Placebo pregabalin tablet, oral Night: Placebo pregabalin tablet, oral plus Praga formulation,oral
干预措施: Praga formulation (Drug)
Pregabalin
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral
干预措施: Pregabalin 75mg (Drug)
Pregabalin
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral
干预措施: Pregabalin 150mg (Drug)
Pregabalin
The study is double-dummy. The participant must take pills twice a day, as follows:
Morning:Pregabalin tablet, oral Night: Pregabalin tablet plus, oral placebo Praga formulation, oral
干预措施: Placebo Praga formulation (Other)
结局指标
主要结局
Change from baseline in pain intensity.
时间窗: 3 months
The change in pain intensity from baseline after 3 months of treatment will be scored by Numerical Rating Scale from 0 to 10 points, with 0 = no pain and 10 = worst possible pain, recorded in a participant diary.
次要结局
- Incidence and severity of adverse events recorded during the study.(6 months)