A study on abdominal pain relief in patients with chronic pancreatitis with pregabalin

Phase 4

Not yet recruiting

• Conditions: Alcohol-induced chronic pancreatitis, (2) ICD-10 Condition: K861||Other chronic pancreatitis,

• Registration Number: CTRI/2019/08/020595
• Lead Sponsor: Prof Anoop Saraya

Brief Summary

This study is a randomized, double blind, parallel group placebo controlled trial assessing the efficacy of pregabalin for pain relief in chronic pancreatitis patients. In addition to standard care for chronic pancreatitis, patients in intervention arm will receive adjunctive pregabalin with progressively increasing doses: 75 mg twice daily for 1 week, 150mg twice daily for 1 week and 300mg twice daily for 4 weeks, making a total duration of 6 weeks, while those in control arm will receive matched placebo for 6 weeks. This study will be conducted at a single centre in India. The primary outcome will be pain relief at the end of 6 weeks assessed using Visual analogue scale(VAS). Secondary outcomes assessed will include interference of pain with daily activities, effect of treatment on patient’s life, change in quality of life, percentage of patients becoming pain free and tolerability of pregabalin. In addition change in quantitative sensory testing thresholds will be assessed as an exploratory outcome, and adverse effects would be documented as part of safety outcome.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-08
• Study Start: 2019-01-09

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 months’ 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.

Exclusion Criteria

• 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 subject’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief as assessed using a patient pain diary based on the visual analog scale (VAS).	6 weeks

Secondary Outcome Measures

Name	Time	Method
2.Effect of treatment on patient’s life, as assessed by Patient Global Impression of Change (PGIC)	6 weeks
3.Percentage of patients becoming pain-free during the study period	6 weeks
4.Change in quality of life, as assessed by European Organization for research and treatment of cancer quality of life questionnaire (EORTC QOL-C30)	6 weeks
5.Tolerability of pregabalin	6 weeks
Safety Outcome: Adverse effects would be documented on follow-up visits as well as in periodic telephone interviews	6 weeks
Exploratory Outcome: Change in quantitative sensory testing threshold for pain
1.Interference of pain with daily activities, as assessed by Modified brief pain inventory-short form (mBPI-sf)	6 weeks

Trial Locations

Locations (1)

Pancreas Clinic, AIIMS, New Delhi; 🇮🇳 South, DELHI, India

Pancreas Clinic, AIIMS, New Delhi

🇮🇳South, DELHI, India

Samagra Agarwal

Principal investigator

8826168821

samagra.agarwal@gmail.com