NCT00573469

Brief Summary

The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 24, 2012

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

December 13, 2007

Results QC Date

March 18, 2009

Last Update Submit

July 2, 2012

Conditions

Crohn's Disease

Keywords

gastrointestinalGICrohn's diseaseJapanJapanese

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment

    Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.

    Baseline to 8 weeks

Secondary Outcomes (4)

  • Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment

    Baseline to 2 weeks

  • Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment

    Baseline to 4 weeks

  • Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method

    At 8 weeks

  • Change in CDAI Score From Baseline to 8 Weeks

    Baseline to 8 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

D9421-C 9 mg

Drug: D9421-C, 9mg

2

ACTIVE COMPARATOR

D9421-C 15 mg

Drug: D9421-C, 15mg

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

D9421-C, 9mgDRUG

D9421-C 9 mg was given once daily for 8 weeks.

1
D9421-C, 15mgDRUG

D9421-C 15 mg was given once daily for 8 weeks.

2
PlaceboDRUG

D9421-C matching placebo was given once daily for 8 weeks.

3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female or male aged ≥ 18 and ≤ 65 years
  • Diagnosis of Crohn's Disease

You may not qualify if:

  • Having ileostomy or pouch and/or colostomy
  • Having previous gastric surgery
  • Having a known or suspected systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Research Site

Nagoya, Aichi-ken, Japan

Location

Research Site

Sakura, Chiba, Japan

Location

Research Site

Chikushino-shi, Fukuoka, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

Research Site

Kurume, Fukuoka, Japan

Location

Research Site

Hashima-gun, Gifu, Japan

Location

Research Site

Fukuyama, Hiroshima, Japan

Location

Research Site

Hiroshima, Hiroshima, Japan

Location

Research Site

Asahikawa, Hokkaido, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Kobe, Hyōgo, Japan

Location

Research Site

Kyoto, Kyoto, Japan

Location

Research Site

Ōita, Oita Prefecture, Japan

Location

Research Site

Kurashiki, Okayama-ken, Japan

Location

Research Site

Osaka, Osaka, Japan

Location

Research Site

Suita, Osaka, Japan

Location

Research Site

Tokorozawa, Saitama, Japan

Location

Research Site

Shinjuku-ku, Tokyo, Japan

Location

Research Site

Toyama, Toyama, Japan

Location

Research Site

Itami, Japan

Location

Research Site

Nishinomiya, Japan

Location

Research Site

Tokyo, Japan

Location

Related Publications (1)

  • Suzuki Y, Motoya S, Takazoe M, Kosaka T, Date M, Nii M, Hibi T. Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II study. J Crohns Colitis. 2013 Apr;7(3):239-47. doi: 10.1016/j.crohns.2012.06.006. Epub 2012 Jul 4.

    PMID: 22766525DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Masataka Date, MD, PhD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

October 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

July 12, 2012

Results First Posted

February 24, 2012

Record last verified: 2012-07

Locations

JP(22)