NL-OMON53887招募中不适用
A phase Ib study to investigate the safety and pharmacokinetics of BR-003 in patients undergoing spinal fusion surgery - STX-102
SentryX0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
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
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •1. Males and females aged between 18 years and 80 years (inclusive)
- •2. Planned for open or percutaneous posterior spinal stabilisation with 4 (for
- •cohort I) or 6 (for
- •cohort II) pedicle screws with a diameter of 5 to 7.5 mm (inclusive) with or
- •without concomitant
- •posterolateral fusion, vertebral augmentation, intervertebral body fusion
- •devices, osteotomies,
- •and posterior decompression. Only primary instrumented spinal surgery cases can
- •be included.
- •3. Willing and able to comply with the protocol for the duration of the study
- •4. Give written informed consent prior to any study-related procedure not part
- •of the standard
- •practice, with the understanding that the consent may be withdrawn by the
- •subject at any time
- •without prejudice to his/her (post-)surgery care
- •5. Females are eligible only if not currently pregnant, nursing, or planning to
- •become pregnant
- •during the study or within 9 months after study drug administration. Female
- •subjects must be surgically sterile, at least 2 years menopausal, or using an
- •acceptable method of birth control.
- •WOCBP, must have a documented negative pregnancy test within 24 hours before
排除标准
- •1. Concomitant anterior/lateral procedures (e.g. anteriorly placed vertebral
- •cage, anterior plating,
- •2. Use of ilium screws or use of (additional) pedicle screws, with a size <
- •5 mm or > 7.5 mm.
- •3. Indication for surgery being:
- •a. Active or previous (para)spinal infection
- •b. Metastatic, malignant or benign tumours of the spine
- •c. Fracture/other traumatic injury
- •4. Known high risk of intra-/postoperative surgical complications (e.g.
- •patients having previously
- •undergone more than 2 non-instrumented spinal surgeries at the index level)
- •5. Planned use of a surgical drain
- •6. Planned use of an epidural catheter
- •7. Use of local amino-amide or amino-ester anaesthetics within 5 days prior to
- •the scheduled
- •surgery (10 days in case of slow release products), peri-op and post op for the
- •first two weeks after the surgery.
- •8. Has a pre-existing concurrent acute or chronic painful physical/restrictive
- •condition expected to
- •require analgesic treatment in the postoperative period for pain that is not
- •strictly related to the
- •surgical indication and which may confound the postoperative assessments.
- •9. Has a medical condition such that, in the opinion of the Investigator,
- •participating in the study
- •would pose a health risk to the subject or confound the postoperative
- •assessments. Conditions
- •may include, but are not limited to, the following:
- •a. History of allergic reactions to bupivacaine or excipients or BR-003, or if
- •investigational product is otherwise contra-indicated
- •b. ASA-classification >3, as assessed during the most recent pre-operative
- •c. Clinically significant renal or hepatic abnormalities (defined as an AST or
- •Upper limit of normal (ULN), creatinine > 2x ULN)
- •d. History of clinically significant cardiac abnormality such as myocardial
- •infarction within
- •6 months prior to study participation, NYHA class III or IV, or clinically
- •significant
- •abnormalities on ECG
- •e. History of coronary artery bypass graft surgery within 12 months prior to
- •participation
- •10. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in
- •the opinion of the
- •Investigator, could interfere with study assessments or compliance
- •11. A body mass index (BMI) > 39 kg/m2 or patients with a weight below 50 kg
- •12. History of, suspected, or known addiction to or abuse of illicit drug(s),
- •prescription medicine(s),
- •13. As per subject history and/or medical records, has active infection or is
- •currently undergoing
- •treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV)
- •14. Participation in another interventional study
研究者
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