Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial
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 50% (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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT|
- Change in the pain score [ Time Frame: Baseline and 8weeks ] [ Designated as safety issue: No ]Pain score will be assessed by the Izbicki pain score, Visual analog scale and painDETECT tool for neuropathic pain.
- Change in number of painful days [ Time Frame: Baseline and 8weeks ] [ Designated as safety issue: No ]The number of days of pain per week will be measured.
- Change in analgesic requirement [ Time Frame: Baseline and 8weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire
- Change in depression scale [ Time Frame: Baseline and 8weeks ] [ Designated as safety issue: No ]Depression will be assessed with the Beck's Depression Inventory.
|Study Start Date:||April 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
This group will contain a placebo for antioxidant cocktail and pregabalin
This group will include placebo.
Experimental: Antioxidant plus pregabalin
This group will contain antioxidant cocktail and pregabalin
Drug: Antioxidant plus Pregabalin
This group will contain combination of antioxidant cocktail and pregabalin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528540
|Asian Institute of Gastroenterology|
|Hyderabad, Andhra Pradesh, India, 500082|
|Principal Investigator:||Rupjyoti Talukdar, MD||Asian Institue of Gastroenterology|