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Multicenter, randomized, double-blind, placebo-controlled study on the efficacy and safety of indomethacin suppositories in the treatment of acute pancreatitis

Multicenter, randomized, double-blind, placebo-controlled study on the efficacy and safety of indomethacin suppositories in the treatment of acute pancreatitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127381
Enrollment
Unknown
Registered
2026-06-30
Start date
2024-11-30
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Acute pancreatitis

Interventions

Indomethacin group:Indomethacin suppository 50mg q12h rectal administration, continuous for 7 days
or in mild cases less than 7 days but clinical improvement reached discharge criteria (complete relief of abdominal pain, sustained normal body temperature, C-reactive protein decreased to within 150m
Placebo group:Placebo 50mg q12h rectal administration, continuous for 7 days

Sponsors

Chinese Academy of Medical Science & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for acute pancreatitis (typical abdominal pain, pancreatic enzyme elevation more than three times the upper limit of normal, typical imaging changes); 2. Time from onset to hospital visit should be within 24 hours, and time from visit to enrollment should be within 8 hours; 3. Age 18-80 years; 4. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Abdominal pain symptoms have persisted for more than 24 hours at the time of consultation; 2. Severe hepatic dysfunction (referring to acute liver failure or decompensated cirrhosis) or abnormal renal function (>1.5 times the normal value); 3. Patients with active gastrointestinal bleeding, peptic ulcers, or other contraindications to NSAIDs; 4. Pregnancy or lactation; 5. Severe cardiovascular or cerebrovascular diseases such as heart failure, myocardial infarction, or stroke; 6. Uncontrolled hypertension; 7. Allergy to NSAID medications; 8. Mental disorders preventing cooperation; 9. Acute pancreatitis caused by malignant tumors; 10. Post-ERCP pancreatitis; 11. Failure to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Incidence of organ failure within one week after admission;

Secondary

MeasureTime frame
Mortality within the first month of hospitalization;Length of stay in the intensive care unit during the first month after admission;Incidence of pancreatic necrosis;Medical economic cost;

Countries

China

Contacts

Public ContactWu Dong

Peking Union Medical College Hospital

wudong061002@aliyun.com+86 186 1267 1010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026