Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: an Randomized Control Trial
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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: an RCT |
- 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.
- 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: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (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 |
Inclusion Criteria:
- Epigastric pain +/- radiation at least thrice in one month over the past three month.
- Endotherapy/Surgery and ducal clearance
- Small duct disease
Exclusion Criteria:
- Age <18 and >65yrs
- MPD and biliary obstruction
- Pancreatic neoplastic lesions
- Acute flare
- Pancreatic pseudocysts
- Pregnancy
- Cardiac and renal diseases
- Use of other anti epileptics
- Hypersensitivity to gabapentin/pregabalin
Contacts and Locations| Contact: Rupjyoti Talukdar, MD | +91 40 2337 8888 | rup_talukdar@yahoo.com |
| 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 | |
| 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: | April 4, 2012 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Asian Institute of Gastroenterology, India:
|
chronic pancreatitis pregabalin antioxidant |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatitis, Chronic Pancreatic Diseases Digestive System Diseases Antioxidants Pregabalin Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 16, 2013