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Canceled by the investigator. Prevention of severe acute pancreatitis with parecoxib and imrecoxib: a multicenter, double-blind, randomized, placebo-controlled clinical trial

Prevention of severe acute pancreatitis with parecoxib and imrecoxib: a multicenter, double-blind, randomized, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032434
Enrollment
Unknown
Registered
2020-04-28
Start date
2020-07-15
Completion date
Unknown
Last updated
2024-03-11

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

Conditions

acute pancreatitis

Interventions

Experimental group:conventional treatment + parecoxib 40mg, iv, once a day for 3 days, and then imrecoxib, taken orally, 100mg each time, 2 times a day, for 27 days
Control group:conventional treatment + placebo B1, 1 injection each time, iv, once a day for 3 days, and then placebo B2, taken orally, 1 tablet each time, 2 times a day, for 27 days

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. consistent with the diagnosis of acute pancreatitis, having at least two of the following: (1) abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe, epigastric pain often radiating to the back); (2) serum amylase activity or lipase activity at least three times greater than the upper limit of normal; (3) characteristic findings of acute pancreatitis on computed tomography or magnetic resonance imaging or transabdominal ultrasonography; 2. either gender aged 18-75 years; 3. a score of APACHE II >=8; 4. no organ failure or transient organ failure lasting no more than 48 hours; 5. non-steroidal anti-inflammatory drugs and other similar drugs (e.g., glucocorticoids) were not used in the 2 weeks prior to the trial; 6. written informed consent was obtained from the patients or their legal representatives.

Exclusion criteria

Exclusion criteria: 1. drug allergy; 2. pregnancy and breast-feeding mother; 3. severe chronic diseases such as cardiac dysfunction, chronic obstructive pulmonary disease, renal insufficiency; as well as severe diseases in digestive system, including cirrhosis, esophageal varices, peptic ulcer, gastrointestinal bleeding in recent month, ulcerative colitis and Crohn's disease 4. drug abuse and psychosis.

Design outcomes

Primary

MeasureTime frame
The incidence of severe acute pancreatitis;The scores of organ failure;

Secondary

MeasureTime frame
The scores of APACHE II;The scores of systemic inflammatory response syndrome (SIRS);The modified CT severity index;Local complications;Index of inflammation;The length of hospital stay;Hospital cost;

Countries

China

Contacts

Public ContactChengwei Tang

West China Hospital, Sichuan University

shcqcdmed@163.com+86 18980601275

Outcome results

None listed

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