Acute pancreatitis
Conditions
Interventions
Trade Name: ARTRINOVO DEBIL SUPOSITORIOS
Pharmaceutical Form: Rectal capsule
INN or Proposed INN: INDOMETHACIN SODIUM TRIHYDRATE
Current Sponsor code: 620385
Concentration unit: mg milligram(s)
Conce
Sponsors
Enrique de Madaria Pascual
Eligibility
Sex/Gender
All
Inclusion 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 (38ºC, heart rate >90/min, respiratory rate >20/min or PaCO212,000/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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain, United States
Contacts
Public ContactEnrique de Madaria Pascual
Enrique de Madaria Pascual
Outcome results
None listed