An interventional study of Placebo and Antioxidant plus Pregabalin in Chronic Pancreatitis, sponsored by Asian Institute of Gastroenterology, India. Completed at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by Asian Institute of Gastroenterology, India · Not applicable, Interventional, and Treatment
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.
751 studies on the registry are indexed under Pancreatitis; 180 are open to participants now.
This study's enrollment of 87 is close to the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Asian Institute of Gastroenterology, India is the lead sponsor of 132 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will contain a placebo for antioxidant cocktail and pregabalin
Drug: Placebo
This group will contain antioxidant cocktail and pregabalin
Drug: Antioxidant plus Pregabalin
This group will include placebo.
This group will contain combination of antioxidant cocktail and pregabalin
Change in the pain score
Pain score will be assessed by the Izbicki pain score, Visual analog scale and painDETECT tool for neuropathic pain.
Time frame: Baseline and 8weeks
Change in number of painful days
The number of days of pain per week will be measured.
Time frame: Baseline and 8weeks
Change in analgesic requirement
The type (opiate/non-opiate), number and route of additional analgesic medicines that were required within the study period will be evaluated.
Time frame: Baseline and 8weeks
Change in quality of life
QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire
Time frame: Baseline and 8weeks
Change in depression scale
Depression will be assessed with the Beck's Depression Inventory.
Time frame: Baseline and 8weeks
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asian Institute of Gastroenterology, India