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Clinical Trials/EUCTR2014-004844-37-ES
EUCTR2014-004844-37-ES
Active, Not Recruiting
N/A

A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis

Enrique de Madaria Pascual0 sites40 target enrollmentMay 8, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute pancreatitis
Sponsor
Enrique de Madaria Pascual
Enrollment
40
Status
Active, Not Recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 8, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Enrique de Madaria Pascual

Eligibility Criteria

Inclusion Criteria

  • Patients ages 18 or above admitted to hospital with a diagnosis of Acute pancreatitis (AP) based on at least 2 of the followin criteria: (i)abdominal pain characteristic of AP; (ii) serum amylase and/or lipase\>\= 3 times the upper limit of normal; and/or (iii) characteristic findings of AP on abdominal CT scan .
  • Patients with SIRS (\<\= 2 of the following criteria: temperature \<36ºC or \>38ºC, heart rate \>90/min, respiratory rate \>20/min or PaCO2\<32 mm Hg , WBC\<4,000/mm3, \>12,000/mm3 or \>10% bands) upon hospital admission or who develop SIRS within 48 hrs of admission.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 20
  • F.1\.3 Elderly (\>\=65 years) no
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • More than 48 hrs since the onset of abdominal paien, absence of SIRS within 48 hrs of presentation, presence of OF, presence of renal dysfunction, active peptic ulcer disease, use of daily NSAIDs within 1 week of presentation and or allergy to NSAIDs.

Outcomes

Primary Outcomes

Not specified

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