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Parecoxib sequential with imrecoxib for the prevention and treatment of severe acute pancreatitis: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study

Parecoxib sequential with imrecoxib for the prevention and treatment of severe acute pancreatitis: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032443
Enrollment
Unknown
Registered
2020-04-28
Start date
2020-12-24
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Severe Acute Pancreatitis

Interventions

Placebo group:Conventional therapy+Placebo (drug B1 1 needle qd. iv. 3days + drug B2 1 tablet bid. po. 27 days)
COX-2 inhibitors group:Conventional therapy+COX-2 inhibitors (drug A1-Parecoxib 1 needle qd. iv. 3days + drug B2- Imrecoxib 1 tablet bid. po. 27 days)

Sponsors

Department of Gastroenterology, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of AP 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 computed tomography (CT) and less commonly magnetic resonance imaging (MRI) or abdominal ultrasonography; 2. Inpatients aged 18-75 years; 3. Onset of symptoms to admission no more than 1 week; 4. APACHE II score >= 7 or modified Marshall score >= 2;

Exclusion criteria

Exclusion criteria: 1. The use of non-steroidal anti-inflammatory drugs or glucocorticoids within 2 weeks prior enrollment; 2. Known allergy to sulfonamide drugs; 3. Pregnancy and lactation; 4. Presence of severe chronic diseases, such as cardiac dysfunction, chronic obstructive pulmonary disease, or renal insufficiency; 5. Severe digestive system diseases, such as liver cirrhosis, peptic ulcer with a history of gastrointestinal bleeding in the past month, chronic pancreatitis, and inflammatory bowel disease; 6. Drug abuse and psychosis.

Design outcomes

Primary

MeasureTime frame
Duration of organ failure;

Secondary

MeasureTime frame
Pancreatic necrosis;Presences of local complications;The use of mechanical ventilation or CRRT;Response to anti-infection treatment;Systemic inflammatory response syndrome score;ICU transfers;30-day mortality;The duration of hospital stay;The cost during hospitalization;Serum inflammatory markers;Others;

Countries

China

Contacts

Public ContactChengwei Tang

Department of Gastroenterology, West China Hospital, Sichuan University

shcqcdmed@163.com+86 189 8060 1275

Outcome results

None listed

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