2023-504143-14-00招募中4 期
Metamizole as pain treatment in patients with chronic pancreatitis, a multicenter, randomized, double-blind, placebo-controlled trial.
Stichting Radboud University Medical Center10 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年10月11日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 10
- 主要终点
- Mean daily pain intensity score, recorded during the 4-week intervention by the patient using a 11-point numerical rating (0 = no pain to 10 = worst pain imaginable)
研究概览
简要总结
To study if adding metamizole three times daily at a dosage of 1000mg to the current analgesic therapy effectively reduce pain in patients with painful chronic pancreatitis, with time since diagnosis of less than 3 years
研究设计
- 分配方式
- Randomized
- 主要目的
- Intervention phase
- 盲法
- Double (Investigator, Analyst, Carer, Subject, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Confirmed chronic pancreatitis
- •Abdominal pain typical for chronic pancreatitis (i.e. dull epigastric pain), NRS ≥ 3, ≥ 3 days/week for two weeks
排除标准
- •Endoscopic or surgical intervention < 3 months prior to inclusion
- •Expected endoscopic or surgical intervention for CP within trial duration (6 weeks)
- •Usage of more than 90 morphine milligram equivalents per day
- •Active use of metamizole at inclusion
- •Contra-indications to metamizole
- •Pancreatic carcinoma
- •Start of amitriptyline, pregabalin or gabapentin less than 6 weeks prior to inclusion
结局指标
主要结局
Mean daily pain intensity score, recorded during the 4-week intervention by the patient using a 11-point numerical rating (0 = no pain to 10 = worst pain imaginable)
Mean daily pain intensity score, recorded during the 4-week intervention by the patient using a 11-point numerical rating (0 = no pain to 10 = worst pain imaginable)
次要结局
- Izbicki pain score
- COMPAT-SF
- mean of maximum daily pain intensity score
- number of patients achieving successful pain reduction
- number of pain free days
- number of days with acceptable pain
- total amount of milligrams morphine equivalent (MME) and MME required as escape medication
- QoL (PANQOLI and SF-36)
- patient satisfaction (PGIC)
- side effects
研究者
Drs. N.D.E. Thierens
Scientific
Stichting Radboud University Medical Center
研究点 (10)
Loading locations...
相似试验
进行中（未招募）
1 期
Metamizole as pain treatment in patients with chronic pancreatitis, a multicenter, randomized, double-blind, placebo-controlled, superiority trialChronic pancreatitisCTIS2023-504143-14-00Stichting Radboud University Medical Center76
已完成
不适用
se of Metamizole in a Brazilian populatioRBR-5mfy5txSanofi-Aventis Farmacêutica Ltda.
招募中
2 期
Fremanezumab for pain in Complex Regional Pain SyndromeComplex Regional Pain Syndrome2022-503167-15-00Aarhus University Hospital60
招募中
不适用
The impact of taste of metamizole on the pain perception of healthy volunteersAcute painHealthy volunteersR52.0DRKS00022805niversitätsklinikum EssenKlinik für Neurologie165
招募中
4 期
Midazolam and morphine to alleviate symptoms at the end of life in patients on acute geriatric wards2024-517763-22-00UZ Leuven300