Trial record 6 of 1390 for:    "Mayo Clinic" [Exact]

Pentoxifylline Treatment in Acute Pancreatitis (AP)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Santhi Swaroop Vege, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02487225
First received: June 29, 2015
Last updated: June 30, 2015
Last verified: June 2015
  Purpose

This is a single center randomized, double-blind, placebo-controlled study, to be conducted at Mayo Clinic, Rochester, MN.

The objective of our research is to determine whether inhibition of the tumor necrosis factor- alpha (TNF-a) pathway by Pentoxifylline reduces inflammatory markers in AP and whether it is safe, beneficial and well-tolerated in patients with acute pancreatitis AP. The study will have 2 groups of 75 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 3 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation of C-reactive protein (C-RP), Interleukin-6 (IL-6), Interleukin-8 (IL-8) and Tumor Necrosis Factor-alpha (TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier.

Subjects will be adult patients =18 years or older admitted to the hospital within 72 hours of diagnosis of acute pancreatitis (AP) as defined by at least two of the following: (1) amylase and/or lipase greater than 3x upper limit of normal, (2) characteristic cross-sectional imaging, (3) typical abdominal pain. Enrollment into the study should take place 24 hours of admission.

Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials.


Condition Intervention Phase
Acute Pancreatitis (AP)
Gallstone Pancreatitis
Alcoholic Pancreatitis
Acute on Chronic Pancreatitis
Autoimmune Pancreatitis
Idiopathic Pancreatitis
Drug: Pentoxifylline
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Determine changes in C-reactive protein (C-RP) from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]
  • Determine changes in Tumor Necrosis Factor-alpha (TNF-a) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]
  • Determine changes in Interleukin-6 (IL-6) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]
  • Determine changes in Interleukin-8 (IL-8) levels from admission baseline at one week. [ Time Frame: Admission (baseline) and then 5 consecutive days ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: May 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pentoxifylline
Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.
Drug: Pentoxifylline
Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cAMP, activates PKA, inhibits TNF and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors
Other Names:
  • Trental
  • Pentox
  • Pentoxil
  • Flexital
Placebo Comparator: Placebo
Placebo 400 mg , 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects to receive up to a maximum of 9 doses.
Drug: Placebo
a harmless pill that has no therapeutic effect, used as a control in testing of investigational drug

Detailed Description:

Participants will be put in one of two groups (randomized) by chance (as flip of a coin). This is done so that neither participant nor the investigator will know which group you are in.

Subject will be in either the treatment group (Pentoxifylline medication) or the control group (Placebo). Placebo is a matching pill that has no medication in it.

Participant will take a pill orally (by mouth) starting from the time of admission and enrollment. Participant will receive a total of 9 doses over the three days of hospitalization (72 hours).

Research blood draws will be done to be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier.

The research blood draws can be done at the time of standard patient care blood draws, when a little extra (10 mL or 2 teaspoons) is drawn for the research.

Information from participant 's medical record will be gathered while hospitalized and after dismissal. The study will continue to gather clinical follow up information up to 4 months following hospitalization regarding the diagnosis of acute pancreatitis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Enrollment within 72 hours of diagnosis of AP
  • Ability to give informed consent or a legal adult representative LAR able to give informed consent for subject when needed as defined buy LAR use guidelines.
  • Adult subjects of age ≥18 years.

Exclusion Criteria:

  • Moderate or severe congestive heart failure,
  • History of seizure disorders or demyelinating disease,
  • Nursing mothers,
  • Pregnancy,
  • History of prior tuberculosis or risk factors for tuberculosis
  • Evidence of non- corticosteroid immunosuppression (such as malignancy, chronic renal failure, chemotherapy within 60 days, and HIV)
  • Evidence of active hemorrhage,
  • Paralytic ileus with severe nausea and vomiting.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02487225

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Santhi Swaroop Vege, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Santhi Swaroop Vege, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02487225     History of Changes
Other Study ID Numbers: 15-001710, 1R21DK101889-01A1
Study First Received: June 29, 2015
Last Updated: June 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Alcoholic
Pancreatitis, Chronic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Digestive System Diseases
Pancreatic Diseases
Substance-Related Disorders
Pentoxifylline
Antioxidants
Cardiovascular Agents
Enzyme Inhibitors
Free Radical Scavengers
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Protective Agents
Radiation-Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on July 30, 2015