CTIS2022-503113-31-01招募中1 期
A multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study to investigate the efficacy of oral lidocaine (ORE-001) in preventing gastrointestinal disturbance/intolerance in patients after longitudinal laparotomy - ORE001PhIIPOI
Orexa B.V.0 个研究点目标入组 126 人开始时间: 2023年7月18日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
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 65+（—）
入选标准
- •Patient must be able to understand the requirements of the study and give written informed consent prior to study start., Female patients aged between 18 and 75 years (both inclusive)., Gynecologic surgery performed completely by longitudinal laparotomy., Patient with ECOG Performance status up to 1., Patient is highly likely to comply with the protocol and complete the study., Patient agrees to be scheduled for peridural catheter (PDC).
排除标准
- •Patient has a history of gastrectomy, total colectomy, stoma creation, short bowel syndrome., Clinically significant (at the discretion of the Investigator) abnormal ECG., Intake of any class 1B antiarrhythmic drugs if used for antiarrhythmic purpose (e.g., Lidocaine, Mexiletine, Phenytoin) and of any class 3 antiarrhythmic drugs - Kalium channel blockers (e.g., Amiodarone, Dronedarone, Sotalol, Ibutilide, Dofetilide, Bretylium)., Significant (at the discretion of the Investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection (especially with need of antibiotic treatment) within the past 2 weeks prior to study medication administration., Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration., Pregnancy or planning to become pregnant or nursing during the study., Any other condition, which in the opinion of the Investigator precludes the patient’s participation in the study., Patients with close affiliation with the Investigator or persons working at the respective study sites or patients who are an employee of the Sponsor., Patient has pre-operative ileus., Patient is taking opioid analgesics longer than two post-operative days, exceeding a dosing of 35 mg morphine equivalent per day., Chemotherapy treatment within 10 days after longitudinal surgery., Smoking during the hospital stay., Any contraindication as per summary of product characteristic for the usage of local anesthetics for PDC., History of uncontrolled (at the discretion of the Investigator) cardiovascular, renal, hepatic and/or liver failure., History of severe allergic or anaphylactic reactions, especially to local anesthetics., Clinically significant (at the discretion of the Investigator) deviation from the normal laboratory values.
研究者
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