Chronic PancreatitisPhase 1EUR-1066NCT01159119
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain
A Phase 1 study testing EUR-1066-A, Zenpep and EUR-1066-B in people with Chronic Pancreatitis, run by Forest Laboratories at 1 site in United States.
Trial summary
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- EUR-1066-A, Zenpep and EUR-1066-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2010to 1 Jul 2011
- Phase
- Phase 1
- 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
- Diagnosis of Chronic Pancreatitis
- Exocrine Pancreatic Insufficiency
- Chronic abdominal pain
Who cannot join
- Acute pancreatitis
- Active alcohol consumption
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
Read the detailed description
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.
- Conditions
- Chronic Pancreatitis
- Being tested
- EUR-1066-A, Zenpep, EUR-1066-B
- Keywords
- Chronic Abdominal Pain, Exocrine Pancreatic Insufficiency
- 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.
EUR-1066-ADrug
Also called EUR-1066
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
ZenpepDrug
Capsules taken for daily for 28 days during treatment period 2
EUR-1066-BDrug
Also called EUR-1066
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
| Study group | Role | What they receive |
|---|---|---|
| EUR-1066-A | Experimental | Treatment with Eur-1006-A. Receives: Drug: EUR-1066-A |
| EUR-1066-B | Experimental | Treatment with Eur-1066-B Receives: Drug: EUR-1066-B |
| Zenpep | Active comparator | Control Group: Consist of treatment with Zenpep Receives: Drug: Zenpep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing frequency and severity of pain
Patient diary
Measured: up to 84 days
Secondary outcomes (1)
Changes in fat malabsorption
Assess the coefficient of fat absorption
Measured: up to 124 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study start2 Aug 2010
- Primary completion1 Jul 2011
- Study completion1 Jul 2011
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Phillip Toskes, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159119
- Sponsor's protocol ID
- PR-012
- Acronym
- EUR-1066
- Status last verified
- Dec 2019
- First submitted
- 5 Jul 2010
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain
- ClinicalTrials.gov ID
- NCT01159119
- Acronym / sponsor ID
- EUR-1066 / PR-012
- Conditions
- Chronic Pancreatitis
- Keywords
- Chronic Abdominal Pain, Exocrine Pancreatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- 2 Aug 2010 (actual)
- Primary completion
- 1 Jul 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 9 Jul 2010 (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 study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
Detailed description
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EUR-1066-A | Experimental | Drug: EUR-1066-ATreatment with Eur-1006-A. |
| EUR-1066-B | Experimental | Drug: EUR-1066-BTreatment with Eur-1066-B |
| Zenpep | Active comparator | Drug: ZenpepControl Group: Consist of treatment with Zenpep |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Chronic Pancreatitis
- Exocrine Pancreatic Insufficiency
- Chronic abdominal pain
Key exclusion criteria (3 listed)
- Acute pancreatitis
- Active alcohol consumption
- Uncontrolled diabetes
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 |
|---|---|---|
| EUR-1066-AAlso: EUR-1066Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3. | Drug | EUR-1066-A |
| ZenpepCapsules taken for daily for 28 days during treatment period 2 | Drug | Zenpep |
| EUR-1066-BAlso: EUR-1066Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3. | Drug | EUR-1066-B |
Primary outcome
Comparing frequency and severity of pain
Time frame: up to 84 days
Patient diary
1 secondary outcome
Changes in fat malabsorption
Time frame: up to 124 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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 Toskes, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EUR-1066-A, Zenpep and EUR-1066-B in people with Chronic Pancreatitis, run by Forest Laboratories 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 3 inclusion and 3 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 18 Jan 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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. 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?
Comparing frequency and severity of pain (time frame: up to 84 days). 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 18 Jan 2020.