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Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)

Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01) - Safety and efficacy of polyphosphate for the treatment of ulcerative colitis(AMU002-CR01)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021555
Enrollment
10
Registered
2016-03-31
Start date
2016-04-20
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

Oral administration of polyphosphate Step 1 300mg/day of polyphosphate, after meal in the mornig everyday for 28 days Step 2 1000mg/day of polyphosphate, after meal in the morning everyday for 28 da

Sponsors

Asahikawa Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with refractory ulcerative colitis (Mayo score, 3 to 8; rectal bleeding score, 1 or more; endoscopic subscore, 2 or more)

Exclusion criteria

Exclusion criteria: Patients with drug allergies, renal failure, liver dysfunction, malignancies, pregnancy, history of bowel surgery, infectious colitis, irritable bowel disease, hyperthyroidism or hyperphosphatemia Patients who are judged to be ineligible by the chief study conductor or doctor in charge

Design outcomes

Primary

MeasureTime frame
Frequency and grade of adverse events due to 4-week administration of polyphosphate for the treatment of ulcerative colitis

Secondary

MeasureTime frame
Efficacy of 4-week administration of polyphosphate for improvements in clinical and histological inflammation and the expressions of pro-inflammatory cytokines in the treatment of ulcerative colitis

Countries

Japan

Contacts

Public ContactMikihiro Fujiya

Asahikawa Medical University Division of Gastroenterology and Hematology/Oncology, Department of Medicine

fjym@asahikawa-med.ac.jp81-166-68-2462

Outcome results

None listed

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