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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528540
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : September 9, 2015
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: Placebo Drug: Antioxidant plus Pregabalin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT
Study Start Date : April 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in number of painful days [ Time Frame: Baseline and 8weeks ]
    The number of days of pain per week will be measured.

  2. 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.

  3. Change in quality of life [ Time Frame: Baseline and 8weeks ]
    QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire

  4. Change in depression scale [ Time Frame: Baseline and 8weeks ]
    Depression will be assessed with the Beck's Depression Inventory.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528540

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Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
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Principal Investigator: Rupjyoti Talukdar, MD Asian Institue of Gastroenterology
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Responsible Party: Asian Institute of Gastroenterology, India Identifier: NCT01528540    
Other Study ID Numbers: AIG-PAN-2012-1
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Asian Institute of Gastroenterology, India:
chronic pancreatitis
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Protective Agents