Back to resultsClinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
Primary Purpose
Acute Pancreatitis, Systemic Inflammatory Response Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Indometacin
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis focused on measuring Non-steroidal anti-inflammatory drugs, indomethacin
Eligibility Criteria
Inclusion Criteria: (i) either gender aged 18-70 years; (ii) a confirmed diagnosis of AP; (iii) the time interval from the onset of symptoms to admission was no more than 48 h; (iv) written informed consent was obtained from the patients or their legal representatives. Exclusion Criteria: (i) pregnancy and breast feeding mother; (ii) severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency, cirrhosis, inflammatory bowel diseases, and malignancies; (iii) peptic ulcer; (iv) pancreatitis due to trauma; (v) drug allergy; (vi) drug abuse and psychosis.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
convention
convention + indometacin
Arm Description
patients in convention arm receive conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.
Besides the conventional treatment,patients in convention + indometacin arm receive 50-mg indomethacin suppositories at intervals of 12 hours for a total of 6 doses.
Outcomes
Primary Outcome Measures
Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention.
The minimum value of SIRS is 0, and the maximum value of SIRS is 4. The higher score means a worse outcome.
Secondary Outcome Measures
the serum levels of C-reactive protein(CRP)
The normal range of CRP is 0-10mg/L, and the higher value means a worse outcome.
the serum levels of interleukin-6(IL-6)
The normal range of IL-6 is 0-7pg/ml, and the higher value means a worse outcome.
score of abdominal pain
The range of score of abdominal pain is 0-10, and the higher value means a worse outcome.
Full Information
NCT ID
NCT05637281
First Posted
November 15, 2022
Last Updated
February 15, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05637281
Brief Title
Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
Official Title
Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2022 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Acute pancreatitis is a common critical disease of the digestive system. Accumulated data showed that overexpression of cyclooxygenase-2 (COX-2) in acute pancreatitis and experimental pancreatitis could be attenuated with COX-2 inhibitors. In recent years, it has been found that timely administration of indomethacin or diclofenac sodium to anus after ERCP can significantly reduce the incidence of AP after ERCP in patients at high risk of AP. The aim of this study was to evaluate the efficacy of rectal indomethacin in reducing the systemic inflammatory response syndrome (SIRS) score in AP patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis, Systemic Inflammatory Response Syndrome
Keywords
Non-steroidal anti-inflammatory drugs, indomethacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
convention
Arm Type
Placebo Comparator
Arm Description
patients in convention arm receive conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.
Arm Title
convention + indometacin
Arm Type
Experimental
Arm Description
Besides the conventional treatment,patients in convention + indometacin arm receive 50-mg indomethacin suppositories at intervals of 12 hours for a total of 6 doses.
Intervention Type
Drug
Intervention Name(s)
Indometacin
Other Intervention Name(s)
convention + indometacin
Intervention Description
Besides the conventional treatment, indomethacin will be given to the patients in the convention + indomethacin group.
Intervention Type
Other
Intervention Name(s)
conventional treatment
Other Intervention Name(s)
convention
Intervention Description
All enrolled patients received conventional management according to AP guidelines of International Association of Pancreatology and the Chinese Society of Gastroenterology, including goal-directed fluid resuscitation, oxygen supply even mechanical ventilation, and nutritional support if necessary.
Primary Outcome Measure Information:
Title
Systemic inflammatory response syndrome(SIRS) score at 72 hours after the initial intervention.
Description
The minimum value of SIRS is 0, and the maximum value of SIRS is 4. The higher score means a worse outcome.
Time Frame
72 hours after the initial intervention.
Secondary Outcome Measure Information:
Title
the serum levels of C-reactive protein(CRP)
Description
The normal range of CRP is 0-10mg/L, and the higher value means a worse outcome.
Time Frame
72 hours after the initial intervention.
Title
the serum levels of interleukin-6(IL-6)
Description
The normal range of IL-6 is 0-7pg/ml, and the higher value means a worse outcome.
Time Frame
72 hours after the initial intervention.
Title
score of abdominal pain
Description
The range of score of abdominal pain is 0-10, and the higher value means a worse outcome.
Time Frame
72 hours after the initial intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(i) either gender aged 18-70 years; (ii) a confirmed diagnosis of AP; (iii) the time interval from the onset of symptoms to admission was no more than 48 h; (iv) written informed consent was obtained from the patients or their legal representatives.
Exclusion Criteria:
(i) pregnancy and breast feeding mother; (ii) severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency, cirrhosis, inflammatory bowel diseases, and malignancies; (iii) peptic ulcer; (iv) pancreatitis due to trauma; (v) drug allergy; (vi) drug abuse and psychosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuahua Han
Phone
+86 0571 89713734
Email
hanyaohua@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Gangzhi Zhang
Phone
+8613588153610
Email
arbend@zju.edu.cn
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yuehua han
Phone
+86 0571 89713734
Email
hanyaohua@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Efficacy of Indomethacin in Early Treatment of Acute Pancreatitis
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