A randomized controlled trial of adjunctive incremental pregabalin therapy vs placebo for pain management in chronic pancreatitis

Prof Anoop Saraya0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
•1. Males and females 18-70 years of age
•2. Willing and able to provide informed, written consent
•3. Chronic pancreatitis diagnosed based on Mayo Criteria of at least 6 monthsâ?? duration experiencing abdominal pain attributable to pancreatic pathology;
•4. Exclusion of causes of pancreatic disease other than idiopathic and alcohol related; including autoimmune pancreatitis, obstructive pancreatitis, pancreatic carcinoma
•5. Must be willing and able to comply with all study requirements
•6. Must have serum creatinine <2.0 mg/dL
•7. Patients taking concomitant analgesic medications (other than Gabapentinoids) and those who are expected to stay on a stable regimen during the trial

•Subjects who meet any of the following exclusion criteria are not to be randomized in this study.
•1.generalized painful conditions other than Chronic Pancreatitis
•2.use of antidepressants or anti-epileptic drugs for any indication in the past 6 months
•3.patients who have already been initiated on gabapentinoids for any indication in the past 6 months
•4.pregnancy or lactation
•5.moderate to severe renal impairment
•6.Clinically significant cardiac disease or abnormal electrocardiogram at screening
•7.Any evidence of hepatic decompensation past or present, including ascites, episodes of hepatic encephalopathy, variceal bleeding or a prolonged PT/INR
•8.Major surgical procedure within 30 days prior to screening or the presence of an open wound
•9.Known hypersensitivity to the investigation product or any of its formulation excipients
•10.Unavailable for follow-up assessment or concern for subjectâ??s compliance with the protocol procedures
•11.Any other condition that in the opinion of the investigator renders the subject a poor risk for inclusion into the study.

发起方

Prof Anoop Saraya