Clinical trial NCT01528540: Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control Trial
Official title: Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pancreatitis
Keywords: chronic pancreatitis
pregabalin
antioxidant
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2012-02-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Age \<18 and \>65yrs
2. MPD and biliary obstruction
3. Pancreatic neoplastic lesions
4. Acute flare
5. Pancreatic pseudocysts
6. Pregnancy
7. Cardiac and renal diseases
8. Use of other anti epileptics
9. Hypersensitivity to gabapentin/pregabalin

Primary outcomes:
measure: Change in the pain score
timeFrame: Baseline and 8weeks
Secondary outcomes:
measure: Change in number of painful days
timeFrame: Baseline and 8weeks
measure: Change in analgesic requirement
timeFrame: Baseline and 8weeks
measure: Change in quality of life
timeFrame: Baseline and 8weeks
measure: Change in depression scale
timeFrame: Baseline and 8weeks
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Andhra Pradesh
Study officials:
affiliation: Asian Institue of Gastroenterology
name: Rupjyoti Talukdar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.