Exocrine Pancreatic InsufficiencyPhase 4NCT00744250
Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control
A Phase 4 study testing Pancrelipase in people with Exocrine Pancreatic Insufficiency and Chronic Pancreatitis, run by Digestive Care, Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially coated granules in patients taking exogenous pancreatic enzyme therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic Fibrosis
- What is being tested?
- Pancrelipase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2010
- Phase
- Phase 4
- 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 pancreatic enzyme insufficiency as determined by spot fecal elastase-1 (<75 mcg/g) at the time of screening
- Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
- ≥ 18 years of age
- Male and female subjects
- Able to swallow capsules
- Clinically stable with no evidence of an acute medical conditions
Who cannot join
- History of fibrosing colonopathy in cystic fibrosis subjects
- Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
- Known contraindications, sensitivity or hypersensitivity to porcine pancreatic enzymes, benzocaine or similar products
- Women with a positive serum beta-hCG at the time of screening or the day of the study (due to radiation exposure)
- Liver disease
- ALT or AST ≥ 3 time the upper limit of normal
Show all 15Show fewer
- Bilirubin ≥ 3 times the upper limit of normal
- Acute pancreatitis or acute exacerbation of chronic pancreatitis within 90 days
- Use of medications which affect with intestinal transit (example, narcotics, erythromycin, metoclopramide etc.)
- Subjects receiving treatment with antacids, H2 receptor blockers, or proton pump inhibitors and unable to discontinue these within 72 hr prior to the study day
- Diabetes mellitus
- A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfere with the assessment of enzyme bioavailability
- Small bowel disease (i.e. celiac disease)
- Lactose intolerance
- History of gastric resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency
The purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially coated granules in patients taking exogenous pancreatic enzyme therapy. Specific enzymes activities will be determined from samples of stomach and intestinal fluids after a standard liquid meal.
Read the detailed description
Purpose:
The purpose of this study is to assess the bioavailability of oral Pancrecarb® (exogenous pancreatic enzyme administered orally as a capsule filled with enteric coated granules) compared to placebo control in patients with pancreatic insufficiency. Lipase, amylase and protease activities will be determined from stomach and duodenal aspirates after standard meal stimulation.
Participants:
Patients with pancreatic insufficiency will be recruited as the study population.
Procedures (methods):
Eligible subjects will undergo an initial screening phase and will provide a stool sample to confirm pancreatic exocrine insufficiency based on a spot fecal elastase-1 of < 75 mcg/g stool. Within one month after the screening phase, subjects meeting inclusion criteria will be scheduled to arrive in the GCRC by 7pm. If the subject is a female of child bearing age, a serum pregnancy test will be checked. At 7am the subject will be escorted to fluoroscopy for placement of an oro-enteric tube. Once the tip of the tube has been positioned in the duodenum, the subject will be escorted back to the GCRC. Prior to administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube by the investigators. Subjects will then receive 5 capsules of active drug with a standard liquid Lundh diet of 360 mL over a 10 minute period, administered to simulate a fed state. Then duodenal and gastric secretions will be aspirated from the tube over a 3-hour period. At the end of the 3 hours, the subject will be allowed to rest for 60 minutes. The second phase will consist of 5 capsules of placebo again with a standard liquid Lundh diet , and another 3-hour aspiration phase. After the second 3-hour aspiration period, the balloon will be deflated and the tube will be removed. Subjects will be observed for 30 minutes and then discharged.
- Being tested
- Pancrelipase
- Keywords
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic fibrosis, Pancrelipase, Pancrecarb, Intraduodenal aspiration, Bioavailability
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PancrelipaseDrug
Also called Pancrecarb®
PANCRECARB MS-16
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Pre-treatment vs. post-treatment-
In the first phase, before administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube. Subjects will get 5 placebo capsules at Time=0 given orally with the liquid Lundh diet. Pancreato-biliary and duodenal secretions in the duodenal region will be aspirated continuously over the first 20 min. Gastric and duodenal fluids will be aspirated from 20-180 min at specified time points. Following a rest of 1 hour, the same process will be repeated with the drug capsules. At the end of the study the catheter will be removed and patient will be offered a meal. Receives: Drug: Pancrelipase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes
Measured: Samples will be collected over two consecutive 3 hour study periods and sent for analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionMay 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Digestive Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Lisa Gangarosa, M.D., Principal investigator, University of North Carolina, Chapel HillKim Brouwer, PharmD, PhD, Principal investigator, UNC School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744250
- Sponsor's protocol ID
- GCRC-2712
- Other IDs
- 08-0819
- Status last verified
- Feb 2013
- First submitted
- 28 Aug 2008
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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
- Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency
- ClinicalTrials.gov ID
- NCT00744250
- Acronym / sponsor ID
- GCRC-2712
- Keywords
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, Cystic fibrosis, Pancrelipase, Pancrecarb, Intraduodenal aspiration, Bioavailability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer required study by FDA for NDA approval.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Digestive Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Aug 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 purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially coated granules in patients taking exogenous pancreatic enzyme therapy. Specific enzymes activities will be determined from samples of stomach and intestinal fluids after a standard liquid meal.
Detailed description
Purpose:
The purpose of this study is to assess the bioavailability of oral Pancrecarb® (exogenous pancreatic enzyme administered orally as a capsule filled with enteric coated granules) compared to placebo control in patients with pancreatic insufficiency. Lipase, amylase and protease activities will be determined from stomach and duodenal aspirates after standard meal stimulation.
Participants:
Patients with pancreatic insufficiency will be recruited as the study population.
Procedures (methods):
Eligible subjects will undergo an initial screening phase and will provide a stool sample to confirm pancreatic exocrine insufficiency based on a spot fecal elastase-1 of < 75 mcg/g stool. Within one month after the screening phase, subjects meeting inclusion criteria will be scheduled to arrive in the GCRC by 7pm. If the subject is a female of child bearing age, a serum pregnancy test will be checked. At 7am the subject will be escorted to fluoroscopy for placement of an oro-enteric tube. Once the tip of the tube has been positioned in the duodenum, the subject will be escorted back to the GCRC. Prior to administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube by the investigators. Subjects will then receive 5 capsules of active drug with a standard liquid Lundh diet of 360 mL over a 10 minute period, administered to simulate a fed state. Then duodenal and gastric secretions will be aspirated from the tube over a 3-hour period. At the end of the 3 hours, the subject will be allowed to rest for 60 minutes. The second phase will consist of 5 capsules of placebo again with a standard liquid Lundh diet , and another 3-hour aspiration phase. After the second 3-hour aspiration period, the balloon will be deflated and the tube will be removed. Subjects will be observed for 30 minutes and then discharged.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: PancrelipasePre-treatment vs. post-treatment- In the first phase, before administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube. Subjects will get 5 placebo capsules at Time=0 given orally with the liquid Lundh diet. Pancreato-biliary and duodenal secretions in the duodenal region will be aspirated continuously over the first 20 min. Gastric and duodenal fluids will be aspirated from 20-180 min at specified time points. Following a rest of 1 hour, the same process will be repeated with the drug capsules. At the end of the study the catheter will be removed and patient will be offered a meal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 (<75 mcg/g) at the time of screening
- Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
- ≥ 18 years of age
- Male and female subjects
- Able to swallow capsules
Key exclusion criteria (15 listed)
- History of fibrosing colonopathy in cystic fibrosis subjects
- Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
- Known contraindications, sensitivity or hypersensitivity to porcine pancreatic enzymes, benzocaine or similar products
- Women with a positive serum beta-hCG at the time of screening or the day of the study (due to radiation exposure)
- Liver 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 |
|---|---|---|
| PancrelipaseAlso: Pancrecarb®PANCRECARB MS-16 | Drug | 1 |
Primary outcome
Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes
Time frame: Samples will be collected over two consecutive 3 hour study periods and sent for analysis
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.
Lisa Gangarosa, M.D. principal investigator
University of North Carolina, Chapel Hill
Kim Brouwer, PharmD, PhD principal investigator
UNC School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pancrelipase in people with Exocrine Pancreatic Insufficiency and Chronic Pancreatitis, run by Digestive Care, Inc. at 1 site 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 6 inclusion and 15 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.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes (time frame: Samples will be collected over two consecutive 3 hour study periods and sent for analysis). 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.