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Treatment of Acute Pancreatitis With Ketorolac

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ClinicalTrials.gov Identifier: NCT02885441
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences

Brief Summary:
Patients with acute pancreatitis will be randomly assigned in either study group to receive oral Ketorolac or control group (double blind study).

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: Ketorolac Drug: Placebo Phase 4

Detailed Description:

Patients with acute pancreatitis will be randomly assigned in either study group or control group (double blind study).

  • The study group will receive oral Ketorolac
  • The control group will receive a placebo

Ketorolac is administrated three times daily by mouth starting from the time of admission for the first three days of hospitalization (72 hours).

Hs-CRP will be measured in admission in addition to standard laboratory tests.It 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. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Acute Pancreatitis With Ketorolac
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Ketorolac
Tab Ketorolac,10 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Drug: Ketorolac
Tab Ketorolac, 10 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Other Name: Toradol

Placebo Comparator: Placebo
Tab placebo,10 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Drug: Placebo
Tab Placebo, 10 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.




Primary Outcome Measures :
  1. Change in C-Reactive Protein (CRP) [ Time Frame: baseline, Day 1, Day 3 ]

Secondary Outcome Measures :
  1. Number Of Subjects With New Onset Organ Failure During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
  2. Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
  3. Duration of hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
  4. Mortality [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
  5. Time of beginning and tolerance to nutrition [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Predicted Severe Acute Pancreatitis
  2. Enrollment within 72 hours of diagnosis
  3. Obtaining informed consent
  4. Age >18 years

Exclusion Criteria:

  1. Heart disease, Hypertension
  2. Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
  3. Lactating women
  4. Pregnancy
  5. Advanced renal disease
  6. Hypersensitivity to ketorolac, aspirin, other NSAIDs
  7. Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
  8. Active or history of peptic ulcer disease
  9. Recent or history of GI bleeding or perforation
  10. Inflammatory bowel disease
  11. Severe hepatic impairment or active hepatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885441


Contacts
Contact: Shaahin Shahbazi, MD +98(0)9122048023 mdkabe@gmail.com
Contact: Zahra Vahdat Shariatpanahi, MD, PhD +98(0)9122138186 nutritiondata@yahoo.com

Locations
Iran, Islamic Republic of
Ilam University of Medical Scienvc Recruiting
Ilam, Iran, Islamic Republic of, 6939177143
Contact: Shaahin Shahbazi, MD    98(9)9122048023    mdkabe@gmail.com   
Contact: Zahra Vahdat Shariatpanahi, MD, PhD    98(9)9122138186    nutritiondata@yahoo.com   
Sponsors and Collaborators
Ilam University of Medical Sciences
Investigators
Study Chair: Shaahin Shahbazi, MD Head of Faculty of Medicine

Responsible Party: Zahra Vahdat Shariatpanahi, Associated Professor, Ilam University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02885441     History of Changes
Other Study ID Numbers: 22/52/1663
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences:
Inflammation

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action