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Phase 2a clinical trial for ulcerative colitis using adrenomedullin

Effects of adrenomedullin in steroid-resistant patients with ulcerative colitis: randomized, double-blind, placebo-controlled phase 2a clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080225159
Enrollment
32
Registered
2020-04-10
Start date
2017-03-29
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

ulcerative colitis

Interventions

Sponsors

University of Miyazaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients with steroid-resistant ulcerative colitis

Exclusion criteria

Exclusion criteria: Patient using biologics Patient with fulminant ulcerative colitis (UC) Patient need early operation for UC Patient with precancerous lesion(s) in the colon Patient with active infection Patient with severe complication(s) Patient with malignancy or past history of malignancy Pregnant woman

Design outcomes

Primary

MeasureTime frame
efficacy change of Mayo scores at week 2

Secondary

MeasureTime frame
safety efficacy change of Mayo scores at week 8 effective rate of Mayo scores improvement of Mayo scores Lichtiger index Mayo endoscopy sub-score (MES) fecal immunochemical test and calprotectin at week 2 dose of steroid

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026