FindTrial
Sign In

Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease)

Continuous intravenous adrenomedullin therapy for patients with inflammatory bowel disease (ulcerative colitis and Crohn's disease) - Adrenomedullin therapy for patients with inflammatory bowel disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021421
Enrollment
10
Registered
2016-03-11
Start date
2016-03-14
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

inflammatory bowel disease (ulcerative colitis and Crohn&#39

Interventions

Period up to 2 weeks (14 days) Drug dose continuous intravenous administration of adrenomedullin 1.5 pmol/kg/min for 8 hours per day (09:00 to 17:00)

Sponsors

First Department of Internal Medicine, Faculty of Medicine, University of Miyazaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with inflammatory bowel disease (IBD) fall under any of following conditions 1. moderately to severe active IBD 2. uncontrollable with conventional therapy (5ASA, corticosteroid, calcineurin inhibitors, biological agents)

Exclusion criteria

Exclusion criteria: Patients having one or more of following conditions 1. malignancy 2. pre-carcinoma lesion(s) of the intestine 3. recommended early operation 4. cachexia 5. severe liver dysfunction 6. acute myocardial infarction, unstable angina, myocarditis and stroke within 1 month 7. active infection 8. pregnancy 9. other inappropriate conditions by doctor decision

Design outcomes

Primary

MeasureTime frame
Efficacy improvement of clinical activity score before and after adrenomedullin administration UC: Disease Activity Index score CD: CDAI—

Secondary

MeasureTime frame
1. changes of clinical severity, befor and 2weeks, 4weeks, 8weeks after adrenomedullin administration 2. findings of colonoscopy, , befor and 2weeks, 4weeks, 8weeks after adrenomedullin administration 3. dosage of steroid, , befor and 2weeks, 4weeks, 8weeks after adrenomedullin administration 4. blood pressure and hart rate during AM infusion 5. blood examination—

Countries

Japan

Contacts

Public ContactSinya Ashizuka

Faculty of Medicine, University of Miyazaki First Department of Internal Medicine

shinya_ashizuka@med.miyazaki-u.ac.jp0985-85-9227

Outcome results

None listed

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