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

Asian Institute of Gastroenterology, India

Status: Completed

Conditions: Chronic Pancreatitis

Treatments: Drug: Antioxidant plus Pregabalin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01528540

AIG-PAN-2012-1

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

This group will contain a placebo for antioxidant cocktail and pregabalin

Treatment:

Drug: Placebo

Antioxidant plus pregabalin

Experimental group

Description:

This group will contain antioxidant cocktail and pregabalin

Treatment:

Drug: Antioxidant plus Pregabalin