CTRI/2015/04/005686已完成2 期
A Randomised, Parallel, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of a Single, Peri-articular 5 ml injection of PBF 001 in Male and Female Subjects with Non-specific Lower Back Pain (L5-S1).
Rusan Pharma Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- •Inclusion Criteria
- •To participate in this study, subjects must meet all of the following criteria.
- •1.Given written informed consent prior to study participation.
- •2.Agreed to stop taking pain medication from day -7 until day 14 of the study (rescue medication of 650 mg paracetamol allowed if required)
- •3.Persistent lower back pain (L5-S1) for a minimum of 3 months i.e. very tender low lumbar localised spot just above the pelvic crest (about 3-5 cm) and lateral to the vertebral spine (2-4 cm left or right of the midline, level with the L5-S1 facet joint).
- •4.Male or female subject aged 18 years or over.
- •5.Vital signs within the following ranges:
- •Pulse rate 40-90 bpm
- •Systolic blood pressure 90-140 mmHg
- •Diastolic blood pressure 50-90 mmHg.
- •6.Ability to communicate well with the Investigator and to comply with the requirements of the study.
- •Dosing Day (pre-dose):
- •1.Minimum total pain severity score of 28 over the 7 days immediately prior to dosing
排除标准
- •At screening:
- •1.Presence of any clinically significant medical condition as determined by the Investigator (including active or chronic infection, bacterial, viral, parasitic or worm infections, HIV-1, HIV-2 or Hepatitis B and C)
- •2.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders)
- •3.Present or history of referred pain
- •4.Slipped disc and/or neurological signs in lower limbs past as well as present
- •5.Rheumatoid arthritis and systemic arthritic disease
- •6.Morbid obesity (BMI of 40 Kg/m2 or over)
- •7.Degenerative autoimmune diseases, neurological disease, tumours, kidney diseases and uterine problems
- •8.Pregnant or lactating female patients and those not using contraceptives..
- •9.Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia
- •10.Known or suspected hypersensitivity or idiosyncratic reaction related to any of the investigational medicinal products
- •11.Use of any oral or injected steroids, current or taken within 30 days of screening or during the study (inhaled steroids for asthma are acceptable although dose should remain constant throughout the study if possible)
- •12.Use of warfarin, heparin or other anticoagulants within 30 days of screening or during the study
- •13.Use of anti arrhythmic drugs class III (e.g. amiodarone) within 30 days of screening or during the study
- •14.Use of medication for pain relief from day -7 to follow-up (day 14) apart from rescue medication (650 mg paracetamol).
- •15.Any skin disorder, broken skin, scars or tattoos at the proposed injection site
- •16.History or evidence of drug abuse
- •17.Participation in another clinical study within the last three months.
- •Dosing Day (pre-dose):
- •1.Development of any exclusion criteria since last visit
- •2.Use of any excluded medication since last visit.
研究者
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