NL-OMON33997已完成4 期
A randomized double-blind, placebo-controlled, parallel group clinical study of pregabalin in patients with chronic pancreatitis - The effect of pregabalin treatment in patients with chronic pancreatitis
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- •1. Male or female patients between the ages of 18 and 70 years with a diagnosis of chronic pancreatitis, diagnosed using the Marseille-Rome/Cambridge diagnostic criteria. Both diabetic and non-diabetic patients will be allowed to enter the study.
- •2. The patients must suffer from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (pain >/= 3 days per week in at least 3 months) and must consider their pain as severe enough for medical treatment.
- •3. Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- •4. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
排除标准
- •1. Patients with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
- •2. Presence or history of major depression.
- •3. Patients with previously diagnosed moderate to severe renal impairment. Patients with creatinine values > 2x ULN and/or with a significant change to their normal values should be excluded.
- •4. Patients with a screening 12-lead ECG demonstrating any of the following: heart rate >100 bpm, QRS duration >120 msec, QTc interval >450 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
- •5. Patients with any clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
- •6. Patients treated with pregabalin (Lyrica®) during the previous 4 months.
- •7. Treatment with an investigational drug within 4 months preceding the first dose of study medication of importance for this study as judged by investigator.
- •8. Female patients who are pregnant or lactating, or intend to become pregnant. Male patients who intend to father a child during the course of the study. A pregnancy test will be conducted at visit 1 and 3 to ensure that female patients are not pregnant during the study period.
- •9. Patients unwilling or unable to comply with the lifestyle guidelines.
- •10. Patients must not suffer from painful conditions other than chronic pancreatitis.
- •11. Clinical significant illness within two weeks of participating in this study.
- •12. Involved in planning or conducting the study.
- •13. Hypersensitivity to pregabalin or any of its components.
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