Gonyautoxin 2/3 in the Treatment of Acute Back Pain (Study No CLN 17-032): A Clinical Proof-of-concept Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Algenis SpA
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.
研究概览
简要总结
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving lumbar functionality at short term follow-up in adult patients with acute low back pain, without radiculopathy.
详细描述
This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial.
The primary objective was to determine the clinical efficacy of GTX 2/3 in the decrease of pain and in the functional improvement of adults patients with acute back pain with no associated radiculopathy. The secondary objective was to determine the safety of a local intramuscular injection of GTX 2/3 in adults patients with acute back pain.
Thirty subjects were studied in 2 groups, each consisting of 15 subjects. One group received the Investigational Medicinal Product (IMP) and the other group received placebo.
The eligible patients were adults, from both sex, aged between 18 and 70 years, with an episode of acute back pain without radiculopathy, with a pain intensity higher than 4 in the VAS scale, with no chronic pain and without any severe pathology.
Each subject participated in 1 treatment group only. All subjects received IV administration of 100 mg Ketoprofen before the IMP injection. All patients returned for a follow-up visit at day 4 after dose administration and at day 7 for discharge. Follow up telephone calls were done on day 1, 2 and 3 after the administration.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman patients between 18 and 75 years old.
- •Acute back pain episode without radiculopathy asociated and no red flags.
- •Back pain related pain bigger than 4 in VAS.
- •Patients with no severe illnesses or conditions that would be inappropriate to enroll in this study or patients with no chronic pain.
- •Signed informed consent.
排除标准
- •Pregnant women or breastfeeding.
- •Hyper acute back pain that requires emergency hospitalization.
- •Chronic back pain or complicated (red flags).
- •Patients that have received previous analgesic therapy of long half life, like corticoids, for current back pain or other pathology (inhalers are excluded).
- •Associated neuromuscular diseases, inflammatory diseases in the spine (Musculoskeletal Disorders 2017, 18; 454: 2-12), inability to stand up, tumoral diseases, terminal disease.
- •Ongoing local treatment with calcium antagonists or trinitroglycerin.
- •Treatment with anti-vitamins K or another anticoagulant.
- •Patients with adverse psychosomatic, work or social factors.
- •Known or suspected allergy to any component of the study drug.
- •Current participation in another clinical study or 30 days prior to enrollment.
- •Another condition that in the opinion of the PI prevents participation in the study (physical or mental) or that cannot attend controls or answer the patient's survey / diary.
研究组 & 干预措施
GTX 2/3
Dose level administered of GTX 2/3 was 80 mcg. Dose was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 was injected. The IMP was supplied in glass vials containing 1.2 mL solution at a total GTX 2 and GTX 3 concentration of 40 mcg/mL (at a relative epimer ratio of 62% GTX 2:38% GTX 3).
干预措施: GTX 2/3 (Drug)
Placebo
Placebo was of identical appearance to the IMP, and was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of placebo was injected.
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.
时间窗: 4 days after one local administration
Change of pain (0- to 10-point on a Visual Analog Scale (VAS), 0 meaning no pain and 10 the worst pain) and/or functional improvement (0- to 24-point on the Roland-Morris Disability Questionnaire (RMDQ). Each question is one point so scores can range from 0 (no disability) to 24 (severe disability)) in patients with acute back pain without radiculopathy from baseline to day 4 day after one local administration of GTX 2/3 or placebo.
次要结局
- Use of rescue medication(3 days)
- Pain evaluation on day 2 after GTX 2/3 administration.(2 day after one local administration)
- Pain evaluation on day 1 after GTX 2/3 administration.(1 day after one local administration)
- Efficacy of GTX 2/3 in the treatment of acute back pain after 7 days of administration.(7 days after one local administration)
- Safety of GTX 2/3 by questioning the patients.(Through the 7 days of the study)
- Pain evaluation after 2 hours of GTX 2/3 administration (Discharge of the hospital)(2 hours after one local administration)
- Pain evaluation on day 3 after GTX 2/3 administration.(3 day after one local administration)