Chronic PancreatitisPhase 4NCT00957151
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
A Phase 4 study testing Creon in people with Chronic Pancreatitis, run by Hospital Avicenne.
Trial summary
The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Creon
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Aug 2005
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with chronic pancreatitis and taking enzyme replacement therapy
Who cannot join
- patients with hepatic impairment
- patients allergic to dairy proteins
- urinary incontinence affecting the measurement of nitrogen metabolism
- digestive disorder affecting the absorption of nutrients
About this study
The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.
- Conditions
- Chronic Pancreatitis
- Being tested
- Creon
- Keywords
- chronic pancreatitis, exocrine pancreatic insufficiency, enzyme therapy, patients with chronic pancreatitis and exocrine pancreatic insufficiency, taking enzyme replacement therapy
- Medical subject headings
- Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreonDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis
Secondary outcomes (1)
To determine the efficacy of enzyme therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startApr 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Avicenne
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Robert Benamouzig, Pr, Principal investigator, Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957151
- Sponsor's protocol ID
- 04007
- Status last verified
- Aug 2009
- First submitted
- 11 Aug 2009
- Last updated
- 12 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT00957151
- Acronym / sponsor ID
- 04007
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis, exocrine pancreatic insufficiency, enzyme therapy, patients with chronic pancreatitis and exocrine pancreatic insufficiency, taking enzyme replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospital AvicenneUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Apr 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 12 Aug 2009 (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 objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with chronic pancreatitis and taking enzyme replacement therapy
Key exclusion criteria (4 listed)
- patients with hepatic impairment
- patients allergic to dairy proteins
- urinary incontinence affecting the measurement of nitrogen metabolism
- digestive disorder affecting the absorption of nutrients
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 |
|---|---|---|
| Creon | Drug | – |
Primary outcome
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis
1 secondary outcome
To determine the efficacy of enzyme therapy
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 12 Aug 2009.
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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.
Robert Benamouzig, Pr principal investigator
Department of Gastroenterology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Creon in people with Chronic Pancreatitis, run by Hospital Avicenne.
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 1 inclusion and 4 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 12 Aug 2009. 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. 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 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?
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis. 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 12 Aug 2009.