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

This study has been completed.
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
First received: January 27, 2012
Last updated: September 8, 2015
Last verified: September 2015

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.

Condition Intervention
Chronic Pancreatitis
Drug: Placebo
Drug: Antioxidant plus Pregabalin

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 87
Study Start Date: April 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
This group will contain a placebo for antioxidant cocktail and pregabalin
Drug: Placebo
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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01528540

Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Principal Investigator: Rupjyoti Talukdar, MD Asian Institue of Gastroenterology
  More Information

Responsible Party: Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01528540     History of Changes
Other Study ID Numbers: AIG-PAN-2012-1
Study First Received: January 27, 2012
Last Updated: September 8, 2015
Health Authority: India: Institutional Review Board

Keywords provided by Asian Institute of Gastroenterology, India:
chronic pancreatitis

Additional relevant MeSH terms:
Pancreatitis, Chronic
Digestive System Diseases
Pancreatic Diseases
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 06, 2015