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CTRI Number  CTRI/2019/08/020595 [Registered on: 06/08/2019] Trial Registered Prospectively
Last Modified On: 01/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on abdominal pain relief in patients with chronic pancreatitis with pregabalin 
Scientific Title of Study   A randomized controlled trial of adjunctive incremental pregabalin therapy vs placebo for pain management in chronic pancreatitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samagra Agarwal 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  8826168821  
Fax    
Email  samagra.agarwal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anoop Saraya 
Designation  Professor and Head of department 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9868397203  
Fax    
Email  ansaraya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Samagra Agarwal 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone  8826168821  
Fax    
Email  samagra.agarwal@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 
 
Primary Sponsor  
Name  Prof Anoop Saraya 
Address  Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Samagra Agarwal  Pancreas Clinic, AIIMS, New Delhi  Department of Gastroenterology,All India Institute of Medical Sciences, New Delhi
South
DELHI 		 8826168821

samagra.agarwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K860||Alcohol-induced chronic pancreatitis, (2) ICD-10 Condition: K861||Other chronic pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adjunctive incremental pregabalin  In addition to standard care for chronic pancreatitis, patients in intervention arm will receive pregabalin. The initial dose will be 75mg pregabalin twice daily. After 1 week, this will be increased to 150mg pregabalin twice daily, with a further increase to 300 mg twice daily after 1 week and for the rest of the study period.  
Comparator Agent  Control  Patients in the control arm will receive standard care for chronic pancreatitis, in addition to placebo identical to pregabalin in intervention arm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain relief as assessed using a patient pain diary based on the visual analog scale (VAS).

 		 6 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Interference of pain with daily activities, as assessed by Modified brief pain inventory-short form (mBPI-sf)  6 weeks 
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
 		 6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 
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