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Treatment of Acute Pancreatitis With Ketorolac

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ClinicalTrials.gov Identifier: NCT02885441
Recruitment Status : Terminated
First Posted : August 31, 2016
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE August 23, 2016
First Posted Date  ICMJE August 31, 2016
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
Change in C-Reactive Protein (CRP) [ Time Frame: baseline to Day 5 ]
baseline to Day 5
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
Change in C-Reactive Protein (CRP) [ Time Frame: baseline, Day 1, Day 3 ]
Change History Complete list of historical versions of study NCT02885441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Number Of Subjects With New Onset Organ Failure During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
    30 days or until dismissal date whichever occurs earlier
  • Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
    30 days or until dismissal date whichever occurs earlier
  • Duration of hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
    30 days or until dismissal date whichever occurs earlier
  • Mortality [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
    30 days or until dismissal date whichever occurs earlier
  • Time of beginning and tolerance to nutrition [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
    30 days or until dismissal date whichever occurs earlier
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2016)
  • Number Of Subjects With New Onset Organ Failure During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
  • Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
  • Duration of hospitalization [ Time Frame: 30 days or until dismissal date whichever occurs earlier ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Acute Pancreatitis With Ketorolac
Official Title  ICMJE Treatment of Acute Pancreatitis With Ketorolac
Brief Summary Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.
Detailed Description

Patients with acute pancreatitis will be randomly assigned in either study group or control group.

  • The study group will receive injection or oral Ketorolac.
  • The control group will receive standard medical treatment.

Ketorolac is administrated three times daily by mouth or injection 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pancreatitis
Intervention  ICMJE Drug: Ketorolac
Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
Other Name: Toradol
Study Arms  ICMJE
  • Experimental: Ketorolac
    Ketorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment
    Intervention: Drug: Ketorolac
  • No Intervention: Control
    The standard medical treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 13, 2019)
56
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2016)
100
Actual Study Completion Date  ICMJE February 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02885441
Other Study ID Numbers  ICMJE 22/52/1663
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences
Study Sponsor  ICMJE Ilam University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shaahin Shahbazi, MD Head of Faculty of Medicine
PRS Account Ilam University of Medical Sciences
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP