Crohn's DiseasePhase 2NCT00573469
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
A Phase 2 study testing D9421-C, 9mg and D9421-C, 15mg in people with Crohn's Disease, run by AstraZeneca at 22 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- D9421-C, 9mg and D9421-C, 15mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 22 sitesJapan
- Study dates
- Oct 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged ≥ 18 and ≤ 65 years
- Diagnosis of Crohn's Disease
Who cannot join
- Having ileostomy or pouch and/or colostomy
- Having previous gastric surgery
- Having a known or suspected systemic infection
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Research Site
Asahikawa, Hokkaido
Research Site
Chikushino-shi, Fukuoka
Research Site
Fukuoka, Fukuoka
Research Site
Fukuyama, Hiroshima
Research Site
Hashima-gun, Gifu
Research Site
Hiroshima, Hiroshima
Research Site
Itami
Research Site
Kobe, Hyōgo
Research Site
Kurashiki, Okayama-ken
Research Site
Kurume, Fukuoka
Research Site
Kyoto, Kyoto
Research Site
Nagoya, Aichi-ken
Research Site
Nishinomiya
Research Site
Ōita, Oita Prefecture
Research Site
Osaka, Osaka
Research Site
Sakura, Chiba
Research Site
Sapporo, Hokkaido
Research Site
Shinjuku-ku, Tokyo
Research Site
Suita, Osaka
Research Site
Tokorozawa, Saitama
Research Site
Tokyo
Research Site
Toyama, Toyama
About this study
Official title: 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
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.
- Conditions
- Crohn's Disease
- Being tested
- D9421-C, 9mg, D9421-C, 15mg, Placebo
- Keywords
- gastrointestinal, GI, Crohn's disease, Japan, Japanese
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D9421-C, 9mgDrug
D9421-C 9 mg was given once daily for 8 weeks.
D9421-C, 15mgDrug
D9421-C 15 mg was given once daily for 8 weeks.
PlaceboDrug
D9421-C matching placebo was given once daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | D9421-C 9 mg Receives: Drug: D9421-C, 9mg |
| 2 | Active comparator | D9421-C 15 mg Receives: Drug: D9421-C, 15mg |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (4)
Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment
The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.
Measured: Baseline to 2 weeks
Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment
The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.
Measured: Baseline to 4 weeks
Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method
Time from randomisation to the remission of Crohn's disease defined as CDAI score 150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.
Measured: At 8 weeks
Change in CDAI Score From Baseline to 8 Weeks
CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masataka Date, MD, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573469
- Sponsor's protocol ID
- D9421C00002
- Status last verified
- Jul 2012
- First submitted
- 13 Dec 2007
- Last updated
- 12 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22766525
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00573469
- Acronym / sponsor ID
- D9421C00002
- Conditions
- Crohn's Disease
- Keywords
- gastrointestinal, GI, Crohn's disease, Japan, Japanese
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Posted 24 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: D9421-C, 9mgD9421-C 9 mg |
| 2 | Active comparator | Drug: D9421-C, 15mgD9421-C 15 mg |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female or male aged ≥ 18 and ≤ 65 years
- Diagnosis of Crohn's Disease
Key exclusion criteria (3 listed)
- Having ileostomy or pouch and/or colostomy
- Having previous gastric surgery
- Having a known or suspected systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D9421-C, 9mgD9421-C 9 mg was given once daily for 8 weeks. | Drug | 1 |
| D9421-C, 15mgD9421-C 15 mg was given once daily for 8 weeks. | Drug | 2 |
| PlaceboD9421-C matching placebo was given once daily for 8 weeks. | Drug | 3 |
Primary outcome
Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment
Time frame: Baseline to 8 weeks
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.
4 secondary outcomes
Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment
Time frame: Baseline to 2 weeks
Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment
Time frame: Baseline to 4 weeks
Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method
Time frame: At 8 weeks
Change in CDAI Score From Baseline to 8 Weeks
Time frame: Baseline to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22766525Suzuki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masataka Date, MD, PhD study director
AstraZeneca
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D9421-C, 9mg and D9421-C, 15mg in people with Crohn's Disease, run by AstraZeneca at 22 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00573469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.