Exocrine Pancreatic InsufficiencyPhase 3NCT00559364
Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea
A Phase 3 study testing Viokase® 16, Proton pump inhibitor (PPI) and Omeprazole in people with Exocrine Pancreatic Insufficiency and Chronic Pancreatitis, run by Forest Laboratories at 18 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Pancreatectomy
- What is being tested?
- Viokase® 16, Proton pump inhibitor (PPI) and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Nov 2007to Jul 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
- Patients with causes for EPI other than CP and partial/total pancreas resection, example, cystic fibrosis, primary sclerosing cholangitis, hemochromatosis, isolated enzyme deficiency, deficiency in activation of enzymes in the small intestine etc
- Patients with a history or clinical evidence of any relevant cardio- or cerebrovascular, renal, endocrine, neurologic, infectious, other gastrointestinal, hematological, oncological or psychiatric disease or emotional problems, which, in the opinion of the investigator, would pose a significant risk for the patient, invalidate the giving of informed consent or limit the ability of the patients to comply with study requirements or interfere otherwise with the conduct of the study and the same applies for immunocompromised patients and/or neutropenic patients
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Poland12 sites
III Oddzial Chorób Wewnetrznych i Gastroenterologii
Bialystok, 15 950
Akademickie Centrum Kliniczne
Gdansk, 80 952
Samodzielny Publiczny Centralny
Katowice, 40 752
Klinika Chorob Wewnetrznych z Poliklinika
Krakow, 30 901
Uniwersytecki Szpital Kliniczny nr 1 im
Lodz, 90 153
SP Szpital Kliniczny nr 4 w Lublinie
Lublin, 20 954
Wojewodzki Szpital Specjalistyczny Nr5
Sosnowiec, 40 200
SP Szpital Kliniczny nr 1 Klinika Gastroenterologii
Szczecin, 71 252
Klinika Gastroenterologii i Chorób Przemiany Materii
Warsaw, 02 097
Klinika Chorob Wewnetrznych i Gastroenterologii
Warsaw, 02 507
Wojewodzki Szpital Brodnowski
Warsaw, 03 242
Katedra Klinika Gastroenterologii
Wroclaw, 50 376
Slovakia4 sites
University Hospital Brastislava
Brastislava, 851 07
University Hospital Bratislava
Bratilslava, 826 06
NZZ Management spol.S.r.o.
Nitra, 949 01
Gastro I. s.r.o., Gastroenterologicka
Prešov, 080 01
United States1 site
Darmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency
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).
Read the detailed description
This study is a Phase III, multicenter, randomized, double-blind, parallel, placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the following phases: screening phase (up to 10 days), wash-out phase (6 to 7 days), randomization phase (up to 10 days), and treatment phase (6 to 7 days).
In screening phase, patients will undergo screening procedures prior to entry into the study.
In wash-out phase, stool collection will be performed to allow determination of the baseline CFA.
In randomization phase, patients who qualify for the Treatment Phase (that is, patients who have a CFA% below 80%) will be randomized in the study.
In the treatment phase, patients will be randomized in a 2:1 ratio (Viokase® 16 or Placebo). In treatment phase, stool collection period will be performed to allow determination of the CFA% that will serve to assess the efficacy of Viokase® 16 for the correction of steatorrhea. Follow-up procedures will be scheduled 7 to 10 days after discharge. Patients who do not show abnormal findings, adverse events or concomitant medications during the treatment phase will be assessed via follow-up telephone call. Patients who show abnormal findings (physical examination, vital signs, clinical laboratory tests, adverse events, concomitant medications) during the treatment phase will complete a follow-up visit.
- Being tested
- Viokase® 16, Placebo, Proton pump inhibitor (PPI), Omeprazole
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viokase® 16Drug
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.
PlaceboDrug
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.
Proton pump inhibitor (PPI)Drug
Patients on PPI during Screening will continue their usual PPI therapy throughout the study.
OmeprazoleDrug
Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Viokase® 16 | Experimental | Not described Receives: Drug: Viokase® 16; Drug: Proton pump inhibitor (PPI); Drug: Omeprazole |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Proton pump inhibitor (PPI); Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
Secondary outcomes (2)
Mean Daily Number of Stools
Mean daily number of stools of each patient was calculated from frequency of stools by the patient per day. Mean daily number of stools during the collection period (Day 1 to Day 4 or Day 5 in inpatient period of treatment phase) for total patients was summarized.
Measured: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
Percentage of Stools Categorized as Per Consistency
Stool consistency was categorized as hard, formed/normal, soft and watery. Percentage of stools of a specific consistency for each patient was calculated as: (total number of stools of specific consistency during the completed days of the inpatient period/ total number of stools during the completed days of the inpatient period)*100. Mean percentage of stool categorized as per consistency for total patients was summarized.
Measured: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aptalis Medical Information, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559364
- Sponsor's protocol ID
- VIO16EPI07-01
- Status last verified
- Feb 2017
- First submitted
- 14 Nov 2007
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency
- ClinicalTrials.gov ID
- NCT00559364
- Acronym / sponsor ID
- VIO16EPI07-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Posted 12 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This study is a Phase III, multicenter, randomized, double-blind, parallel, placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the following phases: screening phase (up to 10 days), wash-out phase (6 to 7 days), randomization phase (up to 10 days), and treatment phase (6 to 7 days).
In screening phase, patients will undergo screening procedures prior to entry into the study.
In wash-out phase, stool collection will be performed to allow determination of the baseline CFA.
In randomization phase, patients who qualify for the Treatment Phase (that is, patients who have a CFA% below 80%) will be randomized in the study.
In the treatment phase, patients will be randomized in a 2:1 ratio (Viokase® 16 or Placebo). In treatment phase, stool collection period will be performed to allow determination of the CFA% that will serve to assess the efficacy of Viokase® 16 for the correction of steatorrhea. Follow-up procedures will be scheduled 7 to 10 days after discharge. Patients who do not show abnormal findings, adverse events or concomitant medications during the treatment phase will be assessed via follow-up telephone call. Patients who show abnormal findings (physical examination, vital signs, clinical laboratory tests, adverse events, concomitant medications) during the treatment phase will complete a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viokase® 16Patients 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. | Drug | Viokase® 16 |
| PlaceboPatients 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. | Drug | Placebo |
| Proton pump inhibitor (PPI)Patients on PPI during Screening will continue their usual PPI therapy throughout the study. | Drug | Placebo, Viokase® 16 |
| OmeprazolePatients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study. | Drug | Placebo, Viokase® 16 |
Primary outcome
Percent Coefficient of Fat Absorption (CFA)
Time frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
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.
2 secondary outcomes
Mean Daily Number of Stools
Time frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
Percentage of Stools Categorized as Per Consistency
Time frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aptalis Medical Information study director
Forest Laboratories
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viokase® 16, Proton pump inhibitor (PPI) and Omeprazole in people with Exocrine Pancreatic Insufficiency and Chronic Pancreatitis, run by Forest Laboratories at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Poland, Slovakia, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Coefficient of Fat Absorption (CFA) (time frame: Day 1 up to Day 4 or Day 5 in inpatient period of treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.