Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial

NCT01528540 | Completed DMC

• 1 other identifier: AIG-PAN-2012-1
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Study hypothesis: Combination of antioxidants and pregabalin results in better pain relief than placebo in patients with chronic pancreatitis. Chronic pancreatitis (CP) is a clinical enigma, with pain being the most distressing symptom that brings the patient to clinical attention. Pain in chronic pancreatitis is multifactorial, and may be related to pancreatic ductal hypertension, tissue hypertension, inflammatory cytokines, oxidative stress and neuropathic mechanisms like mechanical allodynia, inflammatory hyperalgesia and temporal summation. The mainstay of treatment for pain in CP due to pancreatic ductal stone is endotherapy (ESWL and ERCP). Recent randomized controlled trials have shown that antioxidant cocktail and pregabalin (a presynaptic voltage gated calcium channel blocking agent) can result in significant reduction of pain in CP. In this study, the investigators will study the efficacy of the combination of antioxidants and pregabalin in reducing pain and compare that with placebo. The investigators will randomize patients with documented chronic pancreatitis with recurrent/persistent pain after undergoing endotherapy and ductal clearance into three groups: Group A- antioxidants + pregabalin; Group B- Placebo. The primary outcome will be change in pain score and the secondary outcomes will be change in the number of painful days, analgesic requirements, quality of life and depression scale. Pain score will be quantified by the Izbicki pain score and visual analog scale; while quality of life and depression will be measured by the EORTC QLQ-C30/PAN26 and Beck depression inventory respectively. Comparison between Group A vs B will be made by the Chi square test/Fischer Exact and the Student's 't' tests respectively and analysis will be done on a intention to treat and per protocol basis. With an expected improvement of pain by 40% (at 80% power and alpha of 0.05) and adjusting for a presumed 10% drop out rate, the required sample size in each group will be at least 40.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; pregabalin; antioxidant

Outcome Measures

Primary Outcomes (1)

• Change in the pain score

  Pain score will be assessed by the Izbicki pain score, Visual analog scale and painDETECT tool for neuropathic pain.

  Baseline and 8weeks

Secondary Outcomes (4)

• Change in number of painful days

  Baseline and 8weeks

• Change in analgesic requirement

  Baseline and 8weeks

• Change in quality of life

  Baseline and 8weeks

• Change in depression scale

  Baseline and 8weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

This group will contain a placebo for antioxidant cocktail and pregabalin

Drug: Placebo

Antioxidant plus pregabalin

EXPERIMENTAL

This group will contain antioxidant cocktail and pregabalin

Drug: Antioxidant plus Pregabalin

Interventions

Placebo DRUG

This group will include placebo.

Placebo

Antioxidant plus Pregabalin DRUG

This group will contain combination of antioxidant cocktail and pregabalin

Antioxidant plus pregabalin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Epigastric pain +/- radiation at least thrice in one month over the past three month.
• Endotherapy/Surgery and ducal clearance

You may not qualify if:

• Age \<18 and \>65yrs
• MPD and biliary obstruction
• Pancreatic neoplastic lesions
• Acute flare
• Pancreatic pseudocysts
• Pregnancy
• Cardiac and renal diseases
• Use of other anti epileptics
• Hypersensitivity to gabapentin/pregabalin

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology

Hyderabad, Andhra Pradesh, 500082, India

Location

Related Publications (2)

• Bhardwaj P, Garg PK, Maulik SK, Saraya A, Tandon RK, Acharya SK. A randomized controlled trial of antioxidant supplementation for pain relief in patients with chronic pancreatitis. Gastroenterology. 2009 Jan;136(1):149-159.e2. doi: 10.1053/j.gastro.2008.09.028. Epub 2008 Sep 25.

  PMID: 18952082 BACKGROUND

• Olesen SS, Bouwense SA, Wilder-Smith OH, van Goor H, Drewes AM. Pregabalin reduces pain in patients with chronic pancreatitis in a randomized, controlled trial. Gastroenterology. 2011 Aug;141(2):536-43. doi: 10.1053/j.gastro.2011.04.003. Epub 2011 Apr 14.

  PMID: 21683078 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Antioxidants; Pregabalin

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rupjyoti Talukdar, MD

  Asian Institue of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 8, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 9, 2015

Record last verified: 2015-09

Locations

IN (1)