Chronic PancreatitisPhase 1AZNCT01142128
Viokase 16, Viokase16 Plus Nexium and Nexium Alone
A Phase 1 study testing Nexium (esomeprazole magnesium) and Viokase 16 (pancrelipase) + Nexium in people with Chronic Pancreatitis, run by University of Florida at 1 site in United States.
Trial summary
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Nexium (esomeprazole magnesium) and Viokase 16 (pancrelipase) + Nexium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.
- History of abdominal pain associated with chronic pancreatitis
- Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase > 100ug/g stool, or serum trypsinogen > 20ng/ml
- -
Who cannot join
- Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
- Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
- Female subjects who are pregnant or lactating
- Subject use of enzyme therapy other than that called for in this study
- Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
- Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Site, Double Blind, Fixed Dose, Cross Over Study of Viokase 16, Viokase16 Plus Nexium and Nexium Alone in the Reduction of Abdominal Pain in Patients With Chronic Pancreatitis
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.
- Conditions
- Chronic Pancreatitis
- Being tested
- Nexium (esomeprazole magnesium), Placebo to Nexium, Viokase 16 (pancrelipase) + Nexium, Viokase 16 + placebo to Nexium
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexium (esomeprazole magnesium)Drug
Also called Nexium
one 40 mg capsule per day for one month
Placebo to NexiumDrug
one capsule per day for one month
Viokase 16 (pancrelipase) + NexiumDrug
Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month
Viokase 16 + placebo to NexiumDrug
Viokase 16 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month
| Study group | Role | What they receive |
|---|---|---|
| Nexium alone | Active comparator | Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium Receives: Drug: Nexium (esomeprazole magnesium) |
| Placebo to Nexium, alone | Placebo comparator | Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium Receives: Drug: Placebo to Nexium |
| Viokase 16 (pancrelipase) + Nexium | Active comparator | Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month. Receives: Drug: Viokase 16 (pancrelipase) + Nexium |
| Viokase 16 + placebo to Nexium | Placebo comparator | Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone Receives: Drug: Viokase 16 + placebo to Nexium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Abdominal Pain for Participants Taking Nexium Alone.
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Measured: 4 months
Reduction of Abdominal Pain for Participants Taking Placebo to Nexium
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Measured: 4 months
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Measured: 4 months
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
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 posted11 Jun 2010 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionMar 2012
Why it stopped: Viokase was taken off market during study and remained off over a year.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Phillip P Toskes, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142128
- Sponsor's protocol ID
- D.9612.L00058
- Acronym
- AZ
- Status last verified
- Feb 2013
- First submitted
- 9 Jun 2010
- Last updated
- 21 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Site, Double Blind, Fixed Dose, Cross Over Study of Viokase 16, Viokase16 Plus Nexium and Nexium Alone in the Reduction of Abdominal Pain in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT01142128
- Acronym / sponsor ID
- AZ / D.9612.L00058
- Conditions
- Chronic Pancreatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Viokase was taken off market during study and remained off over a year.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 21 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nexium alone | Active comparator | Drug: Nexium (esomeprazole magnesium)Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium |
| Placebo to Nexium, alone | Placebo comparator | Drug: Placebo to NexiumPlacebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium |
| Viokase 16 (pancrelipase) + Nexium | Active comparator | Drug: Viokase 16 (pancrelipase) + NexiumViokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month. |
| Viokase 16 + placebo to Nexium | Placebo comparator | Drug: Viokase 16 + placebo to NexiumViokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.
- History of abdominal pain associated with chronic pancreatitis
- Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase > 100ug/g stool, or serum trypsinogen > 20ng/ml
- -
Key exclusion criteria (6 listed)
- Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
- Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
- Female subjects who are pregnant or lactating
- Subject use of enzyme therapy other than that called for in this study
- Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
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 |
|---|---|---|
| Nexium (esomeprazole magnesium)Also: Nexiumone 40 mg capsule per day for one month | Drug | Nexium alone |
| Placebo to Nexiumone capsule per day for one month | Drug | Placebo to Nexium, alone |
| Viokase 16 (pancrelipase) + NexiumViokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month | Drug | Viokase 16 (pancrelipase) + Nexium |
| Viokase 16 + placebo to NexiumViokase 16 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month | Drug | Viokase 16 + placebo to Nexium |
Primary outcome
Reduction of Abdominal Pain for Participants Taking Nexium Alone.
Time frame: 4 months
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Reduction of Abdominal Pain for Participants Taking Placebo to Nexium
Time frame: 4 months
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Nexium
Time frame: 4 months
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Reduction of Abdominal Pain in Participants Taking Viokase 16 Plus Placebo.
Time frame: 4 months
To elucidate the role of Viokase 16 and Nexium in the control of pancreatic pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
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 Nexium (esomeprazole magnesium) and Viokase 16 (pancrelipase) + Nexium in people with Chronic Pancreatitis, run by University of Florida 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 4 inclusion and 6 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 21 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. 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.
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?
Yes. Results are posted in the registry (first posted 21 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction of Abdominal Pain for Participants Taking Nexium Alone. (time frame: 4 months). The study lists 4 primary outcomes in all. 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 21 Feb 2013.