NCT04681066Phase 2Completed

A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-05-15Actual

Enrollment · participants216Actual

Source updated2026-08-24Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-10-16 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

~~Measure: Time to Solid Food Tolerance: gMCP-Modeling Analysis for Dose-response Relationship~~ Measure: Median Time to Solid Food Tolerance

+ After

Measure: Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship

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Study details

Conditions studied

Acute Pancreatitis; Systemic Inflammatory Response Syndrome

Treatments or interventions studied

CM-4620 Injectable Emulsion or CM-4620-IEDrugAlso known as Auxora

Primary outcomes · main study measures

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measure: Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship; description: Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model.; timeFrame: from start of first infusion of study drug (SFISD) through day 30

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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