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

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Brief Title

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

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.
    



Study Type

Interventional


Primary Outcome

Change in the pain score

Secondary Outcome

 Change in number of painful days

Condition

Chronic Pancreatitis

Intervention

Placebo

Study Arms / Comparison Groups

 Placebo
Description:  This group will contain a placebo for antioxidant cocktail and pregabalin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

87

Start Date

April 2012

Completion Date

December 2014

Primary Completion Date

December 2014

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Rupjyoti Talukdar, MD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01528540

Organization ID

AIG-PAN-2012-1


Responsible Party

Sponsor

Study Sponsor

Asian Institute of Gastroenterology, India


Study Sponsor

Rupjyoti Talukdar, MD, Principal Investigator, Asian Institue of Gastroenterology


Verification Date

September 2015