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A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220544
Enrollment
Unknown
Registered
2008-04-09
Start date
2008-04-09
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

Crohn's Disease

Interventions

investigational material(s) Generic name etc : Budesonide INN of investigational material : Therapeutic category code : 245 Adrenal hormone preparations Dosage and Administration for Investigational

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 18 Years to 65 Years Genders Eligible for Study: Both Inclusion Criteria: - Female or male aged >=18 and =< 65 years - Diagnosis of Crohn's Disease Exclusion Criteria: - Having ileostomy or pouch and/or colostomy - Having previous gastric surgery - Having a known or suspected systemic infection

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety/Efficacy Primary Outcome Measures: -The primary outcome variable in this study is the remission after 8-week treatment defined by a CDAI score of =<150. Secondary Outcome Measures: -The secondary outcome variables are Remission after 2-week and 4-week treatment, Time to first remission, change in CDAI score, safety data.—

Outcome results

None listed

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