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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT

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 improve

Detailed Summary:
Sponsor: Asian Institute of Gastroenterology, India

Current Primary Outcome: Change in the pain score [ Time Frame: Baseline and 8weeks ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in number of painful days [ Time Frame: Baseline and 8weeks ]
    The number of days of pain per week will be measured.
  • Change in analgesic requirement [ Time Frame: Baseline and 8weeks ]
    The type (opiate/non-opiate), number and route of additional analgesic medicines that were required within the study period will be evaluated.
  • Change in quality of life [ Time Frame: Baseline and 8weeks ]
    QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire
  • Change in depression scale [ Time Frame: Baseline and 8weeks ]
    Depression will be assessed with the Beck's Depression Inventory.


Original Secondary Outcome: Same as current

Information By: Asian Institute of Gastroenterology, India

Dates:
Date Received: January 27, 2012
Date Started: April 2012
Date Completion:
Last Updated: September 8, 2015
Last Verified: September 2015