Trial of indomethacin in pancreatitis

• Conditions: Acute pancreatitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004844-37-ES
• Lead Sponsor: Enrique de Madaria Pascual

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-08
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy of rectal indomethacin on attenuating systemis inflammation in patients with AP who also have SIRS;Secondary Objective: Not applicable;Primary end point(s): Reduction in systemic inflammation as measured by change in the mean SIRS score prior to and at 48 hrs following initiation of the intervention.;Timepoint(s) of evaluation of this end point: 48 hrs

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable