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

Phase 4

• Conditions: Health Condition 1: K860- Alcohol-induced chronic pancreatitisHealth Condition 2: K861- Other chronic pancreatitis

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 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

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 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.

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). <br/ ><br> <br/ ><br>Timepoint: 6 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Interference of pain with daily activities, as assessed by Modified brief pain inventory-short form (mBPI-sf)Timepoint: 6 weeks;2.Effect of treatment on patientâ??s life, as assessed by Patient Global Impression of Change (PGIC)Timepoint: 6 weeks;3.Percentage of patients becoming pain-free during the study periodTimepoint: 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)Timepoint: 6 weeks;5.Tolerability of pregabalinTimepoint: 6 weeks;Exploratory Outcome: Change in quantitative sensory testing threshold for pain <br/ ><br>Timepoint: 6 weeks;Safety Outcome: Adverse effects would be documented on follow-up visits as well as in periodic telephone interviewsTimepoint: 6 weeks