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Early Intervention with Celecoxib in the Treatment of Acute Pancreatitis: a Multi-center, Double-blind, Randomised, Placebo-controlled trial

Early Intervention with Celecoxib in the Treatment of Acute Pancreatitis: a Multi-center, Double-blind, Randomised, Placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108717
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-03
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pancreatitis

Interventions

Celecoxib group:Routine treatment + oral or tube feeding of celecoxib 200mg twice daily for 7 days
Placebo group:Oral or tube feeding of placebo 200mg twice daily for 7 days

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of AP1 requiring two of the following three features: (1) Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back); (2) Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal; (3) Characteristic findings of AP on CT and less commonly MRI or abdominal ultrasonography; 2. Inpatients aged 18~80 years; 3. Onset of symptoms to enrollment no more than 48 hours; 4. Meet either of the following criteria: (1) SIRS (Systemic Inflammatory Response Syndrome) meeting any two or more of the following: 1) Heart rate > 90 beats/min; 2) Respiratory rate > 20 breaths/min or PaCO2 38°C or 12 × 10^9/L or 43% for males or > 39.6% for females; 3) Serum creatinine level above the upper limit of normal; 4) BMI >= 26 kg/m^2; 5) HbA1c >= 6.5%; 6) Age >= 60 years; 5. Modified Marshall score <2 for either organ.

Exclusion criteria

Exclusion criteria: 1. Known allergy to sulfonamide drugs, history of sulfonamide allergy; 2. Pregnancy and lactation; 3. The use of non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids within 2 weeks prior to enrolment; 4. Presence of severe underlying diseases or dysfunction in vital organs such as the heart, lungs, brain, or kidneys; 5. Severe digestive system diseases, including but not limited to: liver cirrhosis, esophageal varices, peptic ulcer with a history of gastrointestinal bleeding within the past month, ulcerative colitis, Crohn's disease, or chronic pancreatitis; 6. Participants who have been receiving cytotoxic drugs, immunosuppressants, radiotherapy, and chemotherapy for a long time; drug abuse or psychosis.

Design outcomes

Primary

MeasureTime frame
Incidence of organ failure;

Secondary

MeasureTime frame
Duration of organ failure;Modified CT severity index;Safety assessment;Change in SOFA score;Organ Support Usage;Systemic inflammatory indicators;Clinical outcome measures;Incidence of MSAP and SAP;

Countries

China

Contacts

Public ContactChengwei Tang

West China Hospital, Sichuan University

shcqcdmed@163.com+86 28 85422383

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026