Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

NCT00559364 | Completed Phase 3 Results

• 1 other identifier: VIO16EPI07-01
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 18

Brief Summary

This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan).

Conditions

Exocrine Pancreatic Insufficiency; Chronic Pancreatitis; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• Percent Coefficient of Fat Absorption (CFA)

  Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools which was collected from Day 1 to Day 4 or Day 5 during the inpatient period of treatment phase. Mean percent (%) CFA was calculated for Day 1 to Day 4 or Day 5 in inpatient period of treatment phase.

  Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase

Secondary Outcomes (2)

• Mean Daily Number of Stools

  Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase

• Percentage of Stools Categorized as Per Consistency

  Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase

Study Arms (2)

Viokase® 16

EXPERIMENTAL

Drug: Viokase® 16; Drug: Proton pump inhibitor (PPI); Drug: Omeprazole

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: Proton pump inhibitor (PPI); Drug: Omeprazole

Interventions

Viokase® 16 DRUG

Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.

Viokase® 16

Placebo DRUG

Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.

Placebo

Proton pump inhibitor (PPI) DRUG

Patients on PPI during Screening will continue their usual PPI therapy throughout the study.

Placebo; Viokase® 16

Omeprazole DRUG

Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.

Placebo; Viokase® 16

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be male or female, aged 18-80 years
• Patients must have the ability to provide informed consent
• Female patients of childbearing potential must have a negative pregnancy test at screening, must use adequate contraception prior to and during the study and must agree not to attempt to become pregnant during the study; and female patients of non-childbearing potential must be surgically sterile or postmenopausal for at least 12 consecutive months
• Patients must have a medical condition compatible with EPI such as chronic pancreatitis or partial or total resection of the pancreas
• Patients with CP due to alcohol abuse may be included provided they show no clinical symptoms of recent alcohol consumption and no alcohol withdrawal symptoms
• Patients with CP must have at least one of the following conditions: an abnormal secretin test, diffuse calcification of the pancreas on plain film of the abdomen, an abnormal endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound, an abnormal computed tomography (CT) (dilated main pancreatic duct, atrophy or calcification of the pancreas) or serum trypsin concentration below 20 nanogram per milliliter (ng/mL)
• Patients must have evidence of EPI as demonstrated by a fecal elastase (FE-1) determination equal to or below 100 microgram/gram (mcg/g) of stools (FE-1 ScheBo test) at screening
• Patients must have evidence of EPI as manifested by a CFA% below 80% after the wash-out phase
• Patients must be able to comply with a high-fat diet

You may not qualify if:

• Patients with a known hypersensitivity and/or contraindication to any of the study medications, to their excipients, components or to Federal Food, Drug, and Cosmetic (FD and C) Blue No. 2 dye marker
• Patients with acute pancreatitis or with an acute exacerbation of CP at screening or within the last 2 weeks before screening
• Patients with any active or recurrent malignant pancreatic tumor
• Patients with a history of significant bowel resection
• Patients with a dysmotility disorder
• Patients with insufficient body mass (body mass index less than 18)
• Patient not willing to be off therapeutic doses for at least 7 days prior to study entry and throughout the course of the study, medications or products that could interfere with fecal fat excretion
• Patients who do not limit alcohol intake to less than or equal to 1 drink per day during screening and randomization phases and patients who do not refrain from drinking during inpatient periods of the study
• Patients who have been treated with the following drugs within 7 days prior to screening: H2-receptor antagonists, gastrointestinal anticholinergics and antispasmodics
• Patients known to have a significant medical and/or mental disease that would compromise the patient's welfare or confound the study results
• Patients with a history of fibrosing colonopathy, cirrhosis of the liver, or portal hypertension
• Patients who have a condition known to increase fecal fat loss including celiac disease, biliary cancer, biliary stricture, cholelithiasis, Crohn's disease, pancreatic cancer, radiation enteritis, tropical sprue, whipple's disease, lactose intolerance, pseudomembranous colitis
• Female patients who are pregnant or breastfeeding
• Patients who have received an investigational drug within 30 days prior to entering the screening phase of the study
• Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal values or elevated uric acid levels greater than 1.5 times the upper limit of normal values

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (18)

Darmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hotel-Dieu de Levis

Lévis, Quebec, G6V 3Z1, Canada

Location

III Oddzial Chorób Wewnetrznych i Gastroenterologii

Bialystok, 15 950, Poland

Location

Akademickie Centrum Kliniczne

Gdansk, 80 952, Poland

Location

Samodzielny Publiczny Centralny

Katowice, 40 752, Poland

Location

Klinika Chorob Wewnetrznych z Poliklinika

Krakow, 30 901, Poland

Location

Uniwersytecki Szpital Kliniczny nr 1 im

Lodz, 90 153, Poland

Location

SP Szpital Kliniczny nr 4 w Lublinie

Lublin, 20 954, Poland

Location

Wojewodzki Szpital Specjalistyczny Nr5

Sosnowiec, 40 200, Poland

Location

SP Szpital Kliniczny nr 1 Klinika Gastroenterologii

Szczecin, 71 252, Poland

Location

Klinika Gastroenterologii i Chorób Przemiany Materii

Warsaw, 02 097, Poland

Location

Klinika Chorob Wewnetrznych i Gastroenterologii

Warsaw, 02 507, Poland

Location

Wojewodzki Szpital Brodnowski

Warsaw, 03 242, Poland

Location

Katedra Klinika Gastroenterologii

Wroclaw, 50 376, Poland

Location

University Hospital Brastislava

Brastislava, 851 07, Slovakia

Location

University Hospital Bratislava

Bratilslava, 826 06, Slovakia

Location

NZZ Management spol.S.r.o.

Nitra, 949 01, Slovakia

Location

Gastro I. s.r.o., Gastroenterologicka

Prešov, 080 01, Slovakia

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis, Chronic

Interventions

Proton Pump Inhibitors; Omeprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Results for percentage of stool characteristics per bowel movement and number of days with at least 1 stool of specific characteristic were not reported due to change in planned analysis.

Results Point of Contact

• Title: Robert Winkler, MD, VP, Clinical Development and Operations
• Organization: Aptalis Pharma US, Inc.

1-800-472-2634

Study Officials

• Aptalis Medical Information

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 16, 2017
• Results First Posted: March 12, 2014

Record last verified: 2017-02

Locations

PL (12); CA (1); US (1); SL (4)