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NCT04681066 · ClinicalTrials.gov registry record · Phase 2
A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
A Phase 2 study of Acute Pancreatitis and Systemic Inflammatory Response Syndrome, sponsored by CalciMedica.
- Completed
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
- 20
- Study locations
NCT04681066: Completed Phase 2 study of Acute Pancreatitis and Systemic Inflammatory Response Syndrome, sponsored by CalciMedica.
NCT04681066 is a Phase 2 study of Acute Pancreatitis and Systemic Inflammatory Response Syndrome that has completed, run by CalciMedica. The registered enrollment target is 216 participants, below the 2,297-participant average among 10 other Acute Pancreatitis trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04681066, a Phase 2 study of Acute Pancreatitis and Systemic Inflammatory Response Syndrome, has completed, sponsored by CalciMedica.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
- 20
- Study locations
Study Summary
Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection necessitating continued hospitalization.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CM-4620 Injectable Emulsion or CM-4620-IE
Study Locations (20)
California
- Long Beach Medical Center - Long Beach
- LA County Hospital - USC - Los Angeles
- Cedars Sinai - Los Angeles
- University of California at Irvine Medical Center - Orange
- Harbor UCLA Medical Center - Torrance
- Torrance Memorial Medical Center - Torrance
Florida
- Sarasota Memorial Health Care System - Sarasota
- Tampa General Hospital - Tampa
Minnesota
- Methodist Hospital - Saint Louis Park
- Regions Hospital - Saint Paul
Missouri
- University of Missouri School of Medicine - Columbia
- Washington University School of Medicine - St Louis
New York
- Northshore University Hospital - Manhasset
- Icahn School of Medicine at Mount Sinai - New York
Connecticut
- The Stamford Hospital - Stamford
Idaho
- St. Luke's Regional Medical Center - Boise
Illinois
- Northwestern University Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2021-03-24 |
| Est. Completion | 2024-05-15 |
| Phase | Phase 2 |
What the finished NCT04681066 record still lists
NCT04681066 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 2,297-participant average among 10 other Acute Pancreatitis trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Acute Pancreatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04681066 names 20 study sites across 11 states, led by California, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04681066 about?
NCT04681066 is a clinical study titled "A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS". Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. Study drug infusions will occur every 2...
What is the current status of trial NCT04681066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2021-03-24. Estimated completion is 2024-05-15.
What conditions does trial NCT04681066 study?
This clinical trial studies the following conditions: Acute Pancreatitis, Systemic Inflammatory Response Syndrome.
What interventions are being tested in trial NCT04681066?
The interventions under investigation include: Placebo (OTHER), CM-4620 Injectable Emulsion or CM-4620-IE (DRUG).
Who is sponsoring clinical trial NCT04681066?
This trial is sponsored by CalciMedica, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04681066 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04681066's enrollment target sits among peer trials
216 5th of 10 higher than 6 of 10 other Acute Pancreatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pancreatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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