Patients With Acute PancreatitisPhase 2NCT01247961
Early Treatment With Dexamethasone in Mild Acute Pancreatitis
A Phase 2 study testing Dexamethasone acetate in people with Patients With Acute Pancreatitis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This pilot trial will evaluate the following in patients with acute pancreatitis: 1. Safety profile of early treatment with intravenous dexamethasone 2. Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Acute Pancreatitis
- What is being tested?
- Dexamethasone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>=18 years
- Diagnosis of acute pancreatitis confirmed by at least 2 of the following:
- Typical epigastric abdominal pain
- Elevation amylase/lipase >3 times upper limit normal and/or
- Confirmatory findings on cross-sectional imaging
- Enrollment within 8 hours of presentation
Who cannot join
- Class II or greater NYHA heart failure
- Oxygen dependent COPD
- Chronic kidney disease>stage 2
- Cirrhosis
- Existing necrosis on abdominal CT
- Organ dysfunction prior to enrollment
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- Sepsis
- Acute respiratory distress syndrome
- Malignancy not in remission for at least 5 years
- Active drug use
- Known allergy to dexamethasone
- Altered mental status
- Insulin-requiring diabetes
- Abdominal surgery within 60 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial
This pilot trial will evaluate the following in patients with acute pancreatitis:
- Safety profile of early treatment with intravenous dexamethasone
- Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis
- Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes
- Conditions
- Patients With Acute Pancreatitis
- Being tested
- Dexamethasone acetate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone acetateDrug
10 mg intravenous given as single administration with optional repeat dose after 36 hours.
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| 10 mg intravenous dexamethasone | Experimental | Subjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone. Receives: Drug: Dexamethasone acetate |
| Placebo | Placebo comparator | Equal volume of normal saline administered as a single intravenous dose at enrollment. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Inflammation (measured by c-reactive protein level)
C-reactive protein (CRP) is a well-established inflammatory prognostic marker in acute pancreatitis. Primary comparison will be between median CRP levels at 48 hours between treatment arms.
Measured: 48 hours
Secondary outcomes (2)
Safety parameters
We will monitor for incidence of malignant hyperglycemia (blood sugar>400 mg/dL), psychosis or culture-documented infectious complications.
Measured: 72 hours post-randomization
Composite clinical outcome
A composite clinical endpoint including development of either 1) pancreatic necrosis, 2) persistent organ dysfunction defined according to Atlanta symposium criteria 3) requirement for treatment in an intensive care unit and/or 4) development of culture-documented infection will be used to evaluate impact of treatment with dexamethasone on clinical outcomes in the study population.
Measured: Up to 14 days from hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bechien Wu, MD, MPH, Brigham and Women's Hospital
- Investigators
- Bechien U Wu, MD, MPH, Principal investigator, Center for Pancreatic Disease, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247961
- Sponsor's protocol ID
- 2010P-002192
- Status last verified
- Dec 2016
- First submitted
- 19 Nov 2010
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT01247961
- Acronym / sponsor ID
- 2010P-002192
- Conditions
- Patients With Acute Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 25 Nov 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.
This pilot trial will evaluate the following in patients with acute pancreatitis:
- Safety profile of early treatment with intravenous dexamethasone
- Impact of dexamethasone on systemic inflammation in patients with acute pancreatitis
- Provide preliminary data on potential impact of early treatment with steroids on clinical outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mg intravenous dexamethasone | Experimental | Drug: Dexamethasone acetateSubjects randomized to intervention arm will receive single dose of 10 mg intravenous dexamethasone. |
| Placebo | Placebo comparator | Other: PlaceboEqual volume of normal saline administered as a single intravenous dose at enrollment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>=18 years
- Diagnosis of acute pancreatitis confirmed by at least 2 of the following:
- Enrollment within 8 hours of presentation
Key exclusion criteria (14 listed)
- Class II or greater NYHA heart failure
- Oxygen dependent COPD
- Chronic kidney disease>stage 2
- Cirrhosis
- Existing necrosis on abdominal CT
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 |
|---|---|---|
| Dexamethasone acetate10 mg intravenous given as single administration with optional repeat dose after 36 hours. | Drug | 10 mg intravenous dexamethasone |
| PlaceboNormal saline | Other | Placebo |
Primary outcome
Systemic Inflammation (measured by c-reactive protein level)
Time frame: 48 hours
C-reactive protein (CRP) is a well-established inflammatory prognostic marker in acute pancreatitis. Primary comparison will be between median CRP levels at 48 hours between treatment arms.
2 secondary outcomes
Safety parameters
Time frame: 72 hours post-randomization
Composite clinical outcome
Time frame: Up to 14 days from hospital admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
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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.
Bechien U Wu, MD, MPH principal investigator
Center for Pancreatic Disease, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone acetate in people with Patients With Acute Pancreatitis, run by Brigham and Women's Hospital 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 14 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: withdrawn, as of the sponsor's last update on 12 Dec 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Systemic Inflammation (measured by c-reactive protein level) (time frame: 48 hours). 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 Dec 2016.