Exocrine Pancreatic InsufficiencyNCT00749099
Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)
A study testing pancrelipase in people with Exocrine Pancreatic Insufficiency, run by Digestive Care, Inc..
Trial summary
The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal. 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?
- pancrelipase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Sep 2010
- Phase
- Interventional
- 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
- Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic fibrosis
- Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 <75 mcg/g stool at the time of inclusion in the study
- Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
- > 18 years of age
- Male and female subjects qualify
- Able to swallow capsules
- Clinically stable with no evidence of an acute medical condition
- History of steatorrhea
Who cannot join
- History of fibrosing colonopathy in CF subjects
- Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
- Known contraindication, sensitivity or hypersensitivity to porcine pancreatic enzymes
- Active liver disease
- ALT or AST >3 times the upper limit of normal
- Bilirubin >3 times the upper limit of normal
Show all 17Show fewer
- Acute pancreatitis or acute exacerbation of chronic pancreatitis
- Acute treatment with any systemic (oral or IV) antibiotics two weeks prior to screening
- Subjects on erythromycin unwilling to discontinue the treatment two weeks prior to screening
- Receiving treatment with antacids or H2 receptor blockers or proton pump inhibitors and unable to discontinue these treatments prior to day 1
- Inability to cooperate with or non-compliant with required study procedures
- Pregnant, breast feeding
- Current daily prescribed scheduled use of narcotics (patients requiring PRN use of narcotics are not excluded)
- Poorly controlled diabetes
- A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfering with assessment or enzyme bioavailability
- Stomach pH > 4
- Small bowel disease (i.e. celiac disease)
About this study
Official title: 092206: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) From PANCRECARB® (Pancrelipase), Delayed Release Capsules, Buffered and Enteric-Coated Microspheres
The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.
Read the detailed description
Eligible patients for this placebo-controlled study had confirmed exocrine pancreatic insufficiency with a stool pancreatic elastase of <75 mcg/g. Patients who satisfied all inclusion criteria are prepared for endoscopic placement of three Liguory nasal biliary aspiration catheters: one 8.5 fr. catheter in the distal duodenum for aspiration, one 7.0 fr. catheter in the first portion of the duodenum for infusion of a PEG marker (4 mL/min) and one 7.0 fr. in the stomach for aspiration. Baseline samples are obtained from the gastric and distal duodenal ports and placed on ice. Subjects are then asked to swallow 5 capsules of a placebo (Phase I) or the test drug (PANCRECARB® (pancrelipase) - Phase II) with a standardized Lundh meal. Gastric samples are collected once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). All collected samples were tested for the following parameters to demonstrate bioavailability of enzymes originating from PANCRECARB® (pancrelipase): lipase, amylase and protease activities, pH (bicarbonate), and protein fingerprinting by SDS-PAGE analysis.
- Conditions
- Exocrine Pancreatic Insufficiency
- Being tested
- pancrelipase, placebo
- 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.
pancrelipaseDrug
Also called PANCRECARB®
The test drug (PANCRECARB® [pancrelipase] - Phase II) with a standardized Lundh meal.
Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each).
placeboDrug
5 capsules of a placebo drug (Phase I) with a standardized Lundh meal.
Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each).
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Placebo comparator | All subject participate in Phase I Receives: Drug: placebo |
| Phase II | Active comparator | All subject participate in Phase II Receives: Drug: pancrelipase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of the bioavailability of lipase, amylase and protease in the upper intestine from exogenously administered PANCRECARB® (pancrelipase), when taken with a Lundh test meal.
Measured: 4 hours post administration of PANCRECARB® and or Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionSep 2010
- Study completionSep 2010
Why it stopped: No longer required study by FDA for NDA approval.
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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Digestive Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Louis University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749099
- Sponsor's protocol ID
- DCI092206
- Other IDs
- IRB #14687
- Status last verified
- Feb 2013
- First submitted
- 7 Sep 2008
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 092206: Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum) From PANCRECARB® (Pancrelipase), Delayed Release Capsules, Buffered and Enteric-Coated Microspheres
- ClinicalTrials.gov ID
- NCT00749099
- Acronym / sponsor ID
- DCI092206
- Conditions
- Exocrine Pancreatic Insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer required study by FDA for NDA approval.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Digestive Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- St. Louis University
- Study start
- Apr 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Sep 2008 (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.
The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.
Detailed description
Eligible patients for this placebo-controlled study had confirmed exocrine pancreatic insufficiency with a stool pancreatic elastase of <75 mcg/g. Patients who satisfied all inclusion criteria are prepared for endoscopic placement of three Liguory nasal biliary aspiration catheters: one 8.5 fr. catheter in the distal duodenum for aspiration, one 7.0 fr. catheter in the first portion of the duodenum for infusion of a PEG marker (4 mL/min) and one 7.0 fr. in the stomach for aspiration. Baseline samples are obtained from the gastric and distal duodenal ports and placed on ice. Subjects are then asked to swallow 5 capsules of a placebo (Phase I) or the test drug (PANCRECARB® (pancrelipase) - Phase II) with a standardized Lundh meal. Gastric samples are collected once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). All collected samples were tested for the following parameters to demonstrate bioavailability of enzymes originating from PANCRECARB® (pancrelipase): lipase, amylase and protease activities, pH (bicarbonate), and protein fingerprinting by SDS-PAGE analysis.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | Placebo comparator | Drug: placeboAll subject participate in Phase I |
| Phase II | Active comparator | Drug: pancrelipaseAll subject participate in Phase II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented chronic pancreatitis, alcohol induced chronic pancreatitis or cystic fibrosis
- Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 <75 mcg/g stool at the time of inclusion in the study
- Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
- > 18 years of age
- Male and female subjects qualify
Key exclusion criteria (17 listed)
- History of fibrosing colonopathy in CF subjects
- Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
- Known contraindication, sensitivity or hypersensitivity to porcine pancreatic enzymes
- Active liver disease
- ALT or AST >3 times the upper limit of normal
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 |
|---|---|---|
| pancrelipaseAlso: PANCRECARB®The test drug (PANCRECARB® [pancrelipase] - Phase II) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). | Drug | Phase II |
| placebo5 capsules of a placebo drug (Phase I) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each). | Drug | Phase I |
Primary outcome
Evidence of the bioavailability of lipase, amylase and protease in the upper intestine from exogenously administered PANCRECARB® (pancrelipase), when taken with a Lundh test meal.
Time frame: 4 hours post administration of PANCRECARB® and or Placebo
Results and safety
The study was stopped early (reason given: No longer required study by FDA for NDA approval.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pancrelipase in people with Exocrine Pancreatic Insufficiency, run by Digestive Care, Inc..
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 8 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: stopped early, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was stopped early (reason given: No longer required study by FDA for NDA approval.). Results are not available in the source record.
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?
Evidence of the bioavailability of lipase, amylase and protease in the upper intestine from exogenously administered PANCRECARB® (pancrelipase), when taken with a Lundh test meal. (time frame: 4 hours post administration of PANCRECARB® and or Placebo). 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 22 Feb 2013.