Exocrine Pancreatic InsufficiencyPhase 2NCT00559052
An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)
A Phase 2 study testing VIOKASE 16 in people with Exocrine Pancreatic Insufficiency, run by Axcan Pharma at 2 sites in United States.
Trial summary
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency
- What is being tested?
- VIOKASE 16
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have the ability to give informed consent
- Female subjects must use a medically acceptable form of birth control and have a negative pregnancy test upon entering the study and not be breast-feeding
- Subjects must have medical condition compatible with exocrine pancreatic insufficiency
- Subjects must be off therapeutic doses of pancreatic enzyme supplementation prior to study entry day
- Subjects must be on omeprazole at least 5 days prior Day 0.
Who cannot join
- Subjects with a known hypersensitivity and/or contraindication to VIOKASE®16 or to any non-active component of VIOKASE or to any protein of porcine origin
- Subjects with a known hypersensitivity and/or contraindication to omeprazole or to any non-active component of omeprazole
- Subjects on enzyme therapy, H2-receptor antagonists, anticholinergics, antispasmodics prior to study entry
- Female subjects who are pregnant or lactating
- Subjects with acute pancreatitis or acute exacerbations of chronic pancreatic disease
- Subjects with a history of solid organ transplant or significant bowel resection between esophagus and pancreas
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- Subjects who have received an investigational new drug within 30 days prior to entry into the study.
- Subjects with a known coagulopathy
- Subjects with any abnormal liver function test
- Subjects known to have a significant medical and/or mental disease that would compromise the subject's welfare or confound the study results
- Subjects who are not on omeprazole at least 5 days prior Day 0
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shands Hospital, University of Florida
Gainesville, Florida, 32610
Santhi Swaroop Vege, M.D.
Mayo Clinic- Rochester, Minnesota, 55905
About this study
Official title: An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with CP suffering from EPI.
Read the detailed description
Day of screening: Subjects will undergo screening procedures prior to entry into the study.
Day 0: Subjects will be admitted to the facility. Day 1: Subjects will undergo a first perfusion/aspiration procedure. Day 2: Subjects will rest. Day 3: Subjects will undergo a second perfusion/aspiration procedure. Day 4: Subjects will be discharged.
- Conditions
- Exocrine Pancreatic Insufficiency
- Being tested
- VIOKASE 16
- Keywords
- Enzymes, VIOKASE, Bioavailability
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOKASE 16Drug
The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion. |
| 2 | Experimental | The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure. Receives: Drug: VIOKASE 16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.
Measured: 4 months
Secondary outcomes (1)
Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.
Measured: 4 months
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 startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axcan Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AAIPharma, Mayo Clinical Services, City Hospital Laboratory Birmingham
- Investigators
- Phillip P. Toskes, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559052
- Sponsor's protocol ID
- VIO16IP07-01
- Status last verified
- Feb 2010
- First submitted
- 14 Nov 2007
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).
- ClinicalTrials.gov ID
- NCT00559052
- Acronym / sponsor ID
- VIO16IP07-01
- Conditions
- Exocrine Pancreatic Insufficiency
- Keywords
- Enzymes, VIOKASE, Bioavailability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Axcan PharmaIndustry (pharma, biotech, devices)
- Collaborators
- AAIPharma, Mayo Clinical Services, City Hospital Laboratory Birmingham
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EPI leading to maldigestion is a frequent finding in many diseases of the pancreas, such as chronic pancreatitis (CP). Steatorrhea is the most important digestive manifestation in EPI. The current treatment of EPI includes enzyme supplementation with porcine pancreatic enzyme concentrate, consisting mainly of lipase, amylase and protease. An enzyme preparation able to deliver appropriate enzyme levels to the duodenum instead of the mid gut or distal small bowel, would appear to be clinically efficacious for the treatment of steatorrhea in subjects with CP suffering from EPI.
Detailed description
Day of screening: Subjects will undergo screening procedures prior to entry into the study.
Day 0: Subjects will be admitted to the facility. Day 1: Subjects will undergo a first perfusion/aspiration procedure. Day 2: Subjects will rest. Day 3: Subjects will undergo a second perfusion/aspiration procedure. Day 4: Subjects will be discharged.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Baseline measurement. No drug with the liquid meal during perfusion procedure to establish baseline secretion. |
| 2 | Experimental | Drug: VIOKASE 16The Viokase 16 is to be taken as 3 tablets with the liquid meal during perfusion procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have the ability to give informed consent
- Female subjects must use a medically acceptable form of birth control and have a negative pregnancy test upon entering the study and not be breast-feeding
- Subjects must have medical condition compatible with exocrine pancreatic insufficiency
- Subjects must be off therapeutic doses of pancreatic enzyme supplementation prior to study entry day
- Subjects must be on omeprazole at least 5 days prior Day 0.
Key exclusion criteria (11 listed)
- Subjects with a known hypersensitivity and/or contraindication to VIOKASE®16 or to any non-active component of VIOKASE or to any protein of porcine origin
- Subjects with a known hypersensitivity and/or contraindication to omeprazole or to any non-active component of omeprazole
- Subjects on enzyme therapy, H2-receptor antagonists, anticholinergics, antispasmodics prior to study entry
- Female subjects who are pregnant or lactating
- Subjects with acute pancreatitis or acute exacerbations of chronic pancreatic disease
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 16The VIOKASE 16 is to be taken as 3 tablets with the perfusion procedure. | Drug | 2 |
Primary outcome
Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal.
Time frame: 4 months
1 secondary outcome
Evaluation of the Intraduodenal protease and amylase activities following administration of VIOKASE16 tablets in EPI after a liquid meal.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
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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.
Phillip P. Toskes, M.D. principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VIOKASE 16 in people with Exocrine Pancreatic Insufficiency, run by Axcan Pharma at 2 sites in United States.
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 5 inclusion and 11 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 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the Intraduodenal Lipase activity following single dose administration of VIOKASE16 tablets in EPI after a liquid meal. (time frame: 4 months). 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 11 Feb 2010.