Enzyme Suppletion in Exocrine Pancreatic Dysfunction

NCT01430234 | Completed Phase 4

• 1 other identifier: SAPES
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the treatment to be effective. In addition, consultation of a specialized dietician is pivotal to educate patients about the proper use of pancreatic enzymes. However, based on a recent prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI.

Conditions

Chronic Pancreatitis; Exocrine Pancreatic Insufficiency

Keywords

Chronic pancreatitis; Exocrine insufficiency; Pancreatic enzyme replacement therapy; Self-administration

Outcome Measures

Primary Outcomes (1)

• Fecal Fat percentage

  difference in efficacy measured by the fecal fat content during treatment with pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI due to chronic pancreatitis

  week 1, 5 and 9

Secondary Outcomes (6)

• enzyme dose

  On a weekly base during 9 weeks

• Improvement of steatorrhea-related complaints

  On a weekly base during 9 weeks

• Change in dietary habits

  Week 1, 5 and 9

• Patient satisfaction

  Week 4 and 9

• Quality of life

  week 4 and 9

Study Arms (1)

Panzytrat fixed dose vs. self-dosing

OTHER

In Phase I (week 1-4) patients will use the fixed amount of lipase as was prescribed by their treating physician. Phase II (week 5-9) patients will start the self-dosage regimen with pancreatic enzymes (without exceeding the maximum amount of 16 capsules per day). They are properly educated by the researcher and dietician how to adjust the amount of pancreatic enzymes to the fat intake in their diet.

Drug: Panzytrat 25.000 FIP-E units of Lipase

Interventions

Panzytrat 25.000 FIP-E units of Lipase DRUG

patients will experiment with Panzytrat (containing 25.000 units of lipase) to a maximum of 16 capsules a day according to general guidelines.

Also known as: Pancreatine of porcine-origin

Panzytrat fixed dose vs. self-dosing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years.
• EPI caused by CP.
• Treated with enzyme therapy (≤ 6 capsules of 25.000 FIP-E units of lipase per day).
• Fecal elastase \< 0.200 mg/g
• fecal fat-absorption \< 85% without using enzymes.

You may not qualify if:

• Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.
• Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat
• Gastroparesis of any aetiology
• Hypersensitivity to pork protein
• Acute pancreatitis
• Limited life-expectancy of ≤ 6 months
• Malignancy of the pancreas
• Pregnancy/lactation

Sponsors & Collaborators

• Foundation for Liver Research: lead
• Axcan Pharma: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3000 WB, Netherlands

Location

Related Publications (4)

• Ramo OJ, Puolakkainen PA, Seppala K, Schroder TM. Self-administration of enzyme substitution in the treatment of exocrine pancreatic insufficiency. Scand J Gastroenterol. 1989 Aug;24(6):688-92. doi: 10.3109/00365528909093110.

  PMID: 2479083 BACKGROUND

• Czako L, Takacs T, Lonovics J, Lakner L, Dobronte Z, Pronai L, Tulassay Z. [Quality of life in the course of enzyme replacement therapy for chronic pancreatitis]. Orv Hetil. 2002 Jun 23;143(25):1521-7. Hungarian.

  PMID: 12577405 BACKGROUND

• Delhaye M, Meuris S, Gohimont AC, Buedts K, Cremer M. Comparative evaluation of a high lipase pancreatic enzyme preparation and a standard pancreatic supplement for treating exocrine pancreatic insufficiency in chronic pancreatitis. Eur J Gastroenterol Hepatol. 1996 Jul;8(7):699-703.

  PMID: 8853261 BACKGROUND

• Bruno MJ, Tytgat GN. [4 patients with painless diarrhea and weight loss]. Ned Tijdschr Geneeskd. 1994 Dec 17;138(51):2529-33. No abstract available. Dutch.

  PMID: 7830799 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco Bruno, MD, PhD

  Department of Gastroeneterology and Hepatology, Erasmus University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 8, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

NL (1)