Trial record 2 of 584 for:    Open Studies | antioxidants

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Asian Institute of Gastroenterology, India
Sponsor:
Information provided by (Responsible Party):
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01528540
First received: January 27, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 70% (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 39.


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.


Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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

  Eligibility

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

Inclusion Criteria:

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Contacts
Contact: Rupjyoti Talukdar, MD +91 40 2337 8888 rup_talukdar@yahoo.com

Locations
India
Asian Institute of Gastroenterology Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500082
Contact: Rupjyoti Talukdar, MD    +91 40 2337 8888    rup_talukdar@yahoo.com   
Principal Investigator: Rupjyoti Talukdar, MD         
asian Institute of Gastroenterology Recruiting
Hyderabad, Andhra Pradesh, India, 500082
Contact: Rupjyoti Talukdar, MD    914023378888    rup_talukdar@yahoo.com   
Principal Investigator: Rupjyoti Talukdar, MD         
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Principal Investigator: Rupjyoti Talukdar, MD Asian Institue of Gastroenterology
  More Information

Publications:
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: July 10, 2013
Health Authority: India: Institutional Review Board

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

Additional relevant MeSH terms:
Antioxidants
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pregabalin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
GABA Agents
Neurotransmitter Agents
Protective Agents

ClinicalTrials.gov processed this record on October 01, 2014