Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
NCT ID: NCT02706236
Last Updated: 2018-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-04-30
2018-12-31
Brief Summary
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Detailed Description
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Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase: Weeks 4 to 6, there will be cessation of placebo or Pancrelipase use.
Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm receives placebo
Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and non-narcotic usage will also be noted at these intervals. Patient will also report the tobacco and alcohol use.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Intervention Arm
Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.
Pancrelipase
Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks
Placebo Arm
Lactose placebo tablets with meals and snacks, for 4 weeks.
placebo
Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks
Interventions
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Pancrelipase
Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks
placebo
Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of hereditary pancreatitis (PRSS1 gene mutation)
* History of recurrent acute pancreatitis (\>1 documented episode of characteristic abdominal pain associated with diagnostic imaging and/or elevated serum amylase or lipase \> 3 times upper limit of normal).
* Pancreatic calcifications on CT scan
* At least 2 of the following:
* Endoscopic Ultrasound (EUS) with = or \> 4 criteria for chronic pancreatitis (hyperechoic foci, strands, or ducts, lobulation, irregular duct margin, visible side - branches, calcifications, cysts, ductal dilatation) (28)
* Ductal (changes in side branch morphology) or parenchymal (loss of T1 signal intensity) abnormalities on secretin enhanced Magnetic resonance cholangiopancreatography (MRCP)
* Abnormal endoscopic pancreatic secretory function tests (HCO3 \<= 75mmol/L at 30 or 45 minutes or \<= 80mmol/L at 1 hour
* Subjects are capable of informed consent
Exclusion Criteria
* Lactation
* Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation
* Pancreatic cancer
18 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Timothy Gardner
Associate Professor of Medicine
Principal Investigators
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Timothy B Gardner, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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References
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Drewes AM, Krarup AL, Detlefsen S, Malmstrom ML, Dimcevski G, Funch-Jensen P. Pain in chronic pancreatitis: the role of neuropathic pain mechanisms. Gut. 2008 Nov;57(11):1616-27. doi: 10.1136/gut.2007.146621. Epub 2008 Jun 19.
Puylaert M, Kapural L, Van Zundert J, Peek D, Lataster A, Mekhail N, van Kleef M, Keulemans YC. 26. Pain in chronic pancreatitis. Pain Pract. 2011 Sep-Oct;11(5):492-505. doi: 10.1111/j.1533-2500.2011.00474.x. Epub 2011 Jun 16.
Kozarek RA, Ball TJ, Patterson DJ, Brandabur JJ, Traverso LW, Raltz S. Endoscopic pancreatic duct sphincterotomy: indications, technique, and analysis of results. Gastrointest Endosc. 1994 Sep-Oct;40(5):592-8. doi: 10.1016/s0016-5107(94)70260-8.
Bloechle C, Izbicki JR, Knoefel WT, Kuechler T, Broelsch CE. Quality of life in chronic pancreatitis--results after duodenum-preserving resection of the head of the pancreas. Pancreas. 1995 Jul;11(1):77-85. doi: 10.1097/00006676-199507000-00008.
Bellin MD, Freeman ML, Schwarzenberg SJ, Dunn TB, Beilman GJ, Vickers SM, Chinnakotla S, Balamurugan AN, Hering BJ, Radosevich DM, Moran A, Sutherland DE. Quality of life improves for pediatric patients after total pancreatectomy and islet autotransplant for chronic pancreatitis. Clin Gastroenterol Hepatol. 2011 Sep;9(9):793-9. doi: 10.1016/j.cgh.2011.04.024. Epub 2011 May 5.
Radnay PA, Brodman E, Mankikar D, Duncalf D. The effect of equi-analgesic doses of fentanyl, morphine, meperidine and pentazocine on common bile duct pressure. Anaesthesist. 1980 Jan;29(1):26-9. No abstract available.
Wilder-Smith CH, Hill L, Osler W, O'Keefe S. Effect of tramadol and morphine on pain and gastrointestinal motor function in patients with chronic pancreatitis. Dig Dis Sci. 1999 Jun;44(6):1107-16. doi: 10.1023/a:1026607703352.
Green GM, Lyman RL. Feedback regulation of pancreatic enzyme secretion as a mechanism for trypsin inhibitor-induced hypersecretion in rats. Proc Soc Exp Biol Med. 1972 May;140(1):6-12. doi: 10.3181/00379727-140-36384. No abstract available.
Ihse I, Lilja P, Lundquist I. Feedback regulation of pancreatic enzyme secretion by intestinal trypsin in man. Digestion. 1977;15(4):303-8. doi: 10.1159/000198016.
Owyang C, Louie DS, Tatum D. Feedback regulation of pancreatic enzyme secretion. Suppression of cholecystokinin release by trypsin. J Clin Invest. 1986 Jun;77(6):2042-7. doi: 10.1172/JCI112534.
Slaff JI, Wolfe MM, Toskes PP. Elevated fasting cholecystokinin levels in pancreatic exocrine impairment: evidence to support feedback regulation. J Lab Clin Med. 1985 Mar;105(3):282-5.
Brown A, Hughes M, Tenner S, Banks PA. Does pancreatic enzyme supplementation reduce pain in patients with chronic pancreatitis: a meta-analysis. Am J Gastroenterol. 1997 Nov;92(11):2032-5.
Pancreatic Enzyme Supplementation for Treatment of Pain in Adult Patients with Chronic Pancreatitis: a Meta-Analysis and Systematic Review [abstract]. Gardner TB, Michalak D, Harrington MW, et al
Slaff J, Jacobson D, Tillman CR, Curington C, Toskes P. Protease-specific suppression of pancreatic exocrine secretion. Gastroenterology. 1984 Jul;87(1):44-52.
Isaksson G, Ihse I. Pain reduction by an oral pancreatic enzyme preparation in chronic pancreatitis. Dig Dis Sci. 1983 Feb;28(2):97-102. doi: 10.1007/BF01315137.
Catalano MF, Sahai A, Levy M, Romagnuolo J, Wiersema M, Brugge W, Freeman M, Yamao K, Canto M, Hernandez LV. EUS-based criteria for the diagnosis of chronic pancreatitis: the Rosemont classification. Gastrointest Endosc. 2009 Jun;69(7):1251-61. doi: 10.1016/j.gie.2008.07.043. Epub 2009 Feb 24.
Zubarik R, Ganguly E. The rosemont criteria can predict the pain response to pancreatic enzyme supplementation in patients with suspected chronic pancreatitis undergoing endoscopic ultrasoun. Gut Liver. 2011 Dec;5(4):521-6. doi: 10.5009/gnl.2011.5.4.521. Epub 2011 Nov 21.
US Food and Drug Administration. FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States. Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency. May 7th, 2009. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149579.htm
Miyasaka K, Green GM. Effect of partial exclusion of pancreatic juice on rat basal pancreatic secretion. Gastroenterology. 1984 Jan;86(1):114-9.
Louie DS, May D, Miller P, Owyang C. Cholecystokinin mediates feedback regulation of pancreatic enzyme secretion in rats. Am J Physiol. 1986 Feb;250(2 Pt 1):G252-9. doi: 10.1152/ajpgi.1986.250.2.G252.
Lilja P. Effects of intraduodenal amylase, lipase, trypsin, and bile on pancreatic enzyme secretion in the rat. Eur Surg Res. 1980;12(6):383-91. doi: 10.1159/000128145.
Mossner J, Secknus R, Meyer J, Niederau C, Adler G. Treatment of pain with pancreatic extracts in chronic pancreatitis: results of a prospective placebo-controlled multicenter trial. Digestion. 1992;53(1-2):54-66. doi: 10.1159/000200971.
Winstead NS, Wilcox CM. Clinical trials of pancreatic enzyme replacement for painful chronic pancreatitis--a review. Pancreatology. 2009;9(4):344-50. doi: 10.1159/000212086. Epub 2009 May 18.
Waljee AK, Dimagno MJ, Wu BU, Schoenfeld PS, Conwell DL. Systematic review: pancreatic enzyme treatment of malabsorption associated with chronic pancreatitis. Aliment Pharmacol Ther. 2009 Feb 1;29(3):235-46. doi: 10.1111/j.1365-2036.2008.03885.x. Epub 2008 Nov 8.
Gullo L, Barbara L, Labo G. Effect of cessation of alcohol use on the course of pancreatic dysfunction in alcoholic pancreatitis. Gastroenterology. 1988 Oct;95(4):1063-8. doi: 10.1016/0016-5085(88)90184-9.
Midanik L. The validity of self-reported alcohol consumption and alcohol problems: a literature review. Br J Addict. 1982 Dec;77(4):357-82. doi: 10.1111/j.1360-0443.1982.tb02469.x. No abstract available.
Blondet JJ, Carlson AM, Kobayashi T, Jie T, Bellin M, Hering BJ, Freeman ML, Beilman GJ, Sutherland DE. The role of total pancreatectomy and islet autotransplantation for chronic pancreatitis. Surg Clin North Am. 2007 Dec;87(6):1477-501, x. doi: 10.1016/j.suc.2007.08.014.
Sahai AV, Zimmerman M, Aabakken L, Tarnasky PR, Cunningham JT, van Velse A, Hawes RH, Hoffman BJ. Prospective assessment of the ability of endoscopic ultrasound to diagnose, exclude, or establish the severity of chronic pancreatitis found by endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 1998 Jul;48(1):18-25. doi: 10.1016/s0016-5107(98)70123-3.
Other Identifiers
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D16084
Identifier Type: -
Identifier Source: org_study_id
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