Acute PancreatitisEarly Phase 1NCT01292005
Pentoxifylline Treatment of Acute Pancreatitis
A Early Phase 1 study testing Pentoxifylline in people with Acute Pancreatitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2012
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Predicted Severe Acute Pancreatitis
- Enrollment within 72 hours of diagnosis
- Ability to give informed consent
- Age >17 years
Who cannot join
- Moderate or severe congestive heart failure
- History of seizure disorder or demyelinating disease
- Nursing mothers
- Pregnancy
- History of prior tuberculosis or risk factors for tuberculosis
- Evidence of immunosuppression (malignancy, chronic renal failure, chemotherapy within 60 days, ongoing steroid treatment*, and HIV)- (*the exception of prednisone use will be allowed to participate).
Show all 9Show fewer
- Evidence of chronic pancreatitis from history and examination (however, "acute on chronic pancreatitis" diagnosis is allowed)
- Evidence of active or pending hemorrhage.
- Paralytic ileus with vomiting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
The purpose of this study is to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.
Read the detailed description
Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in.
You will be put into either the treatment group or the control group.
- The treatment group will receive a drug called pentoxifylline
- The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours).
When subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.
- Conditions
- Acute Pancreatitis
- Being tested
- Pentoxifylline, Placebo
- Keywords
- pancreatitis, pancreatic necrosis, severe acute pancreatitis (SAP), Alcoholic pancreatitis, gallstone pancreatitis
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing, Pancreatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called Trental
400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
PlaceboDrug
400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
| Study group | Role | What they receive |
|---|---|---|
| Pentoxifylline | Experimental | Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. Receives: Drug: Pentoxifylline |
| Placebo | Placebo comparator | Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-Reactive Protein (CRP)
C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.
Measured: baseline, Day 1, Day 3
Change in Tumor Necrosis Factor (TNF)-Alpha
Normal value range for TNF alpha = 0 - 22 pg/ml.
Measured: baseline, Day 1, Day 3
Change in Interleukin (IL) IL-6
Normal value range for IL-6 = 0 - 5 pg/ml.
Measured: baseline, Day 1, Day 3
Changes in Interleukin (IL) IL-8
Normal value range for IL-8 = 0 - 5 pg/ml.
Measured: baseline, Day 1, Day 3
Secondary outcomes (6)
Number Of Subjects With New Onset Organ Failure During Hospitalization
Measured: 1 week or until dismissal date whichever occurs earlier.
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
Measured: 1 week or until dismissal date whichever occurs earlier
Number of Patients With Lengthy Hospital Stays
"Lengthy" was defined as either greater than 4 days or greater than 10 days.
Measured: 30 days or until dismissal date, whichever occurs earlier
Length of Hospital Stay
Measured: 30 days or until dismissal date, whichever occurs earlier
Length of Intensive Care Unit (ICU) Stay
Measured: 30 days or until dismissal date, whichever occurs earlier
Number of Subjects Who Needed an Intensive Care Unit Stay
Measured: 30 days, or until dismissal, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startApr 2009
- Primary completionJul 2012
- Study completionJul 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santhi Swaroop Vege, M.D., Mayo Clinic
- Investigators
- Santhi S Vege, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292005
- Sponsor's protocol ID
- 08-006648
- Status last verified
- Mar 2016
- First submitted
- 19 Oct 2010
- Last updated
- 25 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23.
PubMed 26112745
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline Treatment in Acute Pancreatitis; A Double-Blind Placebo-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT01292005
- Acronym / sponsor ID
- 08-006648
- Conditions
- Acute Pancreatitis
- Keywords
- pancreatitis, pancreatic necrosis, severe acute pancreatitis (SAP), Alcoholic pancreatitis, gallstone pancreatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 13 Dec 2013
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 determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis, to see if it can improve blood tests associated with inflammation (tissue damage). Pentoxifylline is approved by the US Food and Drug Administration (FDA) for treatment of circulation problems, but its use in this study is investigational, which means that the FDA has not approved it for the treatment of pancreatitis. However, the FDA has allowed the use of pentoxifylline in this research study.
Detailed description
Subjects will be put in one of two groups by chance (as in the flip of a coin). This is done so that neither you nor the investigator will know which group you are in.
You will be put into either the treatment group or the control group.
- The treatment group will receive a drug called pentoxifylline
- The control group will receive a placebo (matching pill that has no medication in it) You will take the pills by mouth starting from the time of admission. You will receive a total of 9 doses over the first three days of your hospitalization (72 hours).
When subject have standard patient care blood draws, additional blood will be taken to do the research tests. The additional blood tests will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. The additional tests will require about 2 teaspoons (10 ml) of blood per day; the maximum amount of extra blood taken would be less than 3 tablespoons (40.0 ml). Information from your medical record will be gathered while you are hospitalized and after your discharge. The study will continue to gather clinical follow up information up to four months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentoxifylline | Experimental | Drug: PentoxifyllinePentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Predicted Severe Acute Pancreatitis
- Enrollment within 72 hours of diagnosis
- Ability to give informed consent
- Age >17 years
Key exclusion criteria (9 listed)
- Moderate or severe congestive heart failure
- History of seizure disorder or demyelinating disease
- Nursing mothers
- Pregnancy
- History of prior tuberculosis or risk factors for tuberculosis
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 |
|---|---|---|
| PentoxifyllineAlso: Trental400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. | Drug | Pentoxifylline |
| Placebo400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses. | Drug | Placebo |
Primary outcome
Change in C-Reactive Protein (CRP)
Time frame: baseline, Day 1, Day 3
C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. The normal value range for CRP = 1-10 mg/L.
Change in Tumor Necrosis Factor (TNF)-Alpha
Time frame: baseline, Day 1, Day 3
Normal value range for TNF alpha = 0 - 22 pg/ml.
Change in Interleukin (IL) IL-6
Time frame: baseline, Day 1, Day 3
Normal value range for IL-6 = 0 - 5 pg/ml.
Changes in Interleukin (IL) IL-8
Time frame: baseline, Day 1, Day 3
Normal value range for IL-8 = 0 - 5 pg/ml.
6 secondary outcomes
Number Of Subjects With New Onset Organ Failure During Hospitalization
Time frame: 1 week or until dismissal date whichever occurs earlier.
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
Time frame: 1 week or until dismissal date whichever occurs earlier
Number of Patients With Lengthy Hospital Stays
Time frame: 30 days or until dismissal date, whichever occurs earlier
Length of Hospital Stay
Time frame: 30 days or until dismissal date, whichever occurs earlier
Length of Intensive Care Unit (ICU) Stay
Time frame: 30 days or until dismissal date, whichever occurs earlier
Number of Subjects Who Needed an Intensive Care Unit Stay
Time frame: 30 days, or until dismissal, whichever came first
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26112745Vege SS, Atwal T, Bi Y, Chari ST, Clemens MA, Enders FT. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial. Gastroenterology. 2015 Aug;149(2):318-20.e3. doi: 10.1053/j.gastro.2015.04.019. Epub 2015 Jun 23.
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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.
Santhi S Vege, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pentoxifylline in people with Acute Pancreatitis, run by Mayo Clinic 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 9 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 25 Oct 2016. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 13 Dec 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?
Change in C-Reactive Protein (CRP) (time frame: baseline, Day 1, Day 3). 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?
On the ClinicalTrials.gov record for NCT01292005, which also lists 1 linked publication.
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 25 Oct 2016.