但丁研究：第一项随机、双盲、安慰剂和活性对照、平行组研究，评估右酮洛芬氨丁三醇和盐酸曲马多口服固定剂量组合对急性下腰痛患者中度至重度急性疼痛的镇痛疗效和安全性——原理与设计
DANTE Study: The First Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Arm Group Study Evaluating the Analgesic Efficacy and Safety of Dexketoprofen TrometAmol aNd Tramadol Hydrochloride Oral FixEd Dose Combination on Moderate to Severe Acute Pain in Patients with Acute Low Back Pain-Rationale and Design.
作者信息
Varrassi Giustino, Hanna Magdi, Coaccioli Stefano, Suada Meto, Perrot Serge
机构信息
Paolo Procacci Foundation, Via Tacito 7, 00193, Rome, Italy.
Analgesics and Pain Research (APR) Ltd, Beckenham, UK.
出版信息
Pain Ther. 2022 Sep;11(3):1055-1070. doi: 10.1007/s40122-022-00407-8. Epub 2022 Jul 5.
INTRODUCTION
Despite a wide range of treatment approaches and the availability of treatment recommendations or guidelines, no consensus on the most effective pharmacological therapy of low back pain (LBP) has been reached yet. Therefore, additional clinical evidence, particularly if built upon a rigorous clinical trial design, an evidence-based medication choice, and broader inclusion criteria better acknowledging the heterogeneity and intrinsic variability of LBP is needed. The DANTE study has been designed to comprehensively assess the analgesic efficacy and tolerability of dexketoprofen/tramadol (DKP/TRAM) 75/25 mg in a large cohort of patients with moderate to severe acute LBP.
METHODS
The DANTE study is a phase IV, multicenter, randomized, double-blind, double-dummy parallel group, placebo, and active controlled study. The DANTE study encompasses a single-dose phase (day 1, t0-t8h) and a multiple-dose phase (from t8h to 8 h after intake of last dose at day 5). The DANTE study population includes patients naïve to LBP or patients with previous history of LBP experiencing a new episode of moderate to severe intensity with or without radiculopathy. The clinical phase of the DANTE study started in September 2020 and the anticipated completion date is April 2022.
PLANNED OUTCOMES
The primary endpoint is the time to first achieve a numeric rating scale-pain intensity (NRS-PI) score of < 4 or a pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose (t8h). Secondary objectives aim are: (1) to evaluate the analgesic efficacy of TRAM/DKP 75/25 mg versus TRAM 100 mg after the first dose; (2) to evaluate the analgesic efficacy of TRAM/DKP 75/25 mg versus TRAM 100 mg after the multiple doses (from t8h until day 5, multiple dose); and (3) to assess the safety and tolerability of the TRAM/DKP 75/25 mg fixed combination after single and multiple doses.
DANTE STUDY REGISTRATION
EudraCT number: 2019-003656-37.
引言
尽管有多种治疗方法以及治疗建议或指南可供参考，但对于腰痛（LBP）最有效的药物治疗尚未达成共识。因此，需要更多的临床证据，特别是基于严谨的临床试验设计、循证药物选择以及更广泛的纳入标准，以更好地认识LBP的异质性和内在变异性。DANTE研究旨在全面评估右酮洛芬/曲马多（DKP/TRAM）75/25毫克在一大群中度至重度急性LBP患者中的镇痛疗效和耐受性。
方法
DANTE研究是一项IV期、多中心、随机、双盲、双模拟平行组、安慰剂和活性对照研究。DANTE研究包括单剂量阶段（第1天，t0至t8小时）和多剂量阶段（从t8小时至第5天最后一剂摄入后8小时）。DANTE研究人群包括初发LBP的患者或有LBP病史且经历了新的中度至重度发作（有或无神经根病）的患者。DANTE研究的临床阶段于2020年9月开始，预计完成日期为2022年4月。
计划结果
主要终点是首次达到数字评定量表-疼痛强度（NRS-PI）评分<4或从首次给药后至8小时（t8小时）疼痛强度降低≥30%的时间。次要目标包括：（1）评估首次给药后TRAM/DKP 75/25毫克与100毫克曲马多的镇痛疗效；（2）评估多剂量给药后（从t8小时至第5天，多剂量）TRAM/DKP 75/25毫克与100毫克曲马多的镇痛疗效；以及（3）评估单剂量和多剂量后TRAM/DKP 75/25毫克固定组合的安全性和耐受性。
DANTE研究注册号：EudraCT编号：2019-003656-37。
Zotero 插件