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

Chronic Pancreatitis Clinical Trial

Official title:

Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528540
• Other study ID #: AIG-PAN-2012-1
• Status: Completed
• Phase: N/A
• First received: January 27, 2012
• Last updated: September 8, 2015
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• Placebo
This group will include placebo.
• Antioxidant plus Pregabalin
This group will contain combination of antioxidant cocktail and pregabalin

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

References & Publications (2)

Bhardwaj P, Garg PK, Maulik SK, Saraya A, Tandon RK, Acharya SK. A randomized controlled trial of antioxidant supplementation for pain relief in patients with chronic pancreatitis. Gastroenterology. 2009 Jan;136(1):149-159.e2. doi: 10.1053/j.gastro.2008.09.028. Epub 2008 Sep 25. — View Citation

Olesen SS, Bouwense SA, Wilder-Smith OH, van Goor H, Drewes AM. Pregabalin reduces pain in patients with chronic pancreatitis in a randomized, controlled trial. Gastroenterology. 2011 Aug;141(2):536-43. doi: 10.1053/j.gastro.2011.04.003. Epub 2011 Apr 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the pain score	Pain score will be assessed by the Izbicki pain score, Visual analog scale and painDETECT tool for neuropathic pain.	Baseline and 8weeks	No
Secondary	Change in number of painful days	The number of days of pain per week will be measured.	Baseline and 8weeks	No
Secondary	Change in analgesic requirement	The type (opiate/non-opiate), number and route of additional analgesic medicines that were required within the study period will be evaluated.	Baseline and 8weeks	No
Secondary	Change in quality of life	QOL will be evaluated with the EORTC QLQ-C30/PAN26 questionnaire	Baseline and 8weeks	No
Secondary	Change in depression scale	Depression will be assessed with the Beck's Depression Inventory.	Baseline and 8weeks	No