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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | D9421-C 9 mg |
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| 2 | Active Comparator | D9421-C 15 mg |
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| 3 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D9421-C, 9mg | Drug | D9421-C 9 mg was given once daily for 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2 weeks |
| Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masataka Date, MD, PhD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22766525 | Derived | 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. |
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Patients who had a CDAI score of less than 200 were excluded before randomisation.
First participant enrolled on 16 October 2006. Last participant completed on 4 March 2008.
Out of 90 screened participants, 77 participants (target was 75) were enrolled and included in Full Analysis set and safety analysis set. The numbers of participants in each set were 26 in D9421-C 9 mg, 25 in D9421-C 15 mg and 26 in Placebo, respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | D9421-C 9 mg | An enteric capsule including D9421-C 9 mg was given once daily. |
| FG001 | D9421-C 15 mg | An enteric capsule including D9421-C 15 mg was given once daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| D9421-C, 15mg |
| Drug |
D9421-C 15 mg was given once daily for 8 weeks. |
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| Placebo | Drug | D9421-C matching placebo was given once daily for 8 weeks. |
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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. |
| 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. | 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. | Baseline to 8 weeks |
| Sakura |
| Chiba |
| Japan |
| Research Site | Chikushino-shi | Fukuoka | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kurume | Fukuoka | Japan |
| Research Site | Hashima-gun | Gifu | Japan |
| Research Site | Fukuyama | Hiroshima | Japan |
| Research Site | Hiroshima | Hiroshima | Japan |
| Research Site | Asahikawa | Hokkaido | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Kobe | Hyōgo | Japan |
| Research Site | Kyoto | Kyoto | Japan |
| Research Site | Ōita | Oita Prefecture | Japan |
| Research Site | Kurashiki | Okayama-ken | Japan |
| Research Site | Osaka | Osaka | Japan |
| Research Site | Suita | Osaka | Japan |
| Research Site | Tokorozawa | Saitama | Japan |
| Research Site | Shinjuku-ku | Tokyo | Japan |
| Research Site | Toyama | Toyama | Japan |
| Research Site | Itami | Japan |
| Research Site | Nishinomiya | Japan |
| Research Site | Tokyo | Japan |
| FG002 | Placebo | An enteric capsule without D9421-C was given once daily. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | D9421-C 9 mg | An enteric capsule including D9421-C 9 mg was given once daily. |
| BG001 | D9421-C 15 mg | An enteric capsule including D9421-C 15 mg was given once daily. |
| BG002 | Placebo | An enteric capsule without D9421-C was given once daily. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age in Years | Number | Participants |
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| Sex: Female, Male | Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Participants | Baseline to 8 weeks |
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| Secondary | 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. | Posted | Number | Participants | Baseline to 2 weeks |
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| Secondary | 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. | Posted | Number | Participants | Baseline to 4 weeks |
|
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| Secondary | 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. | Posted | Number | Percentage of participants | At 8 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D9421-C 9 mg | An enteric capsule including D9421-C 9 mg was given once daily. | 2 | 26 | 18 | 26 | ||
| EG001 | D9421-C 15 mg | An enteric capsule including D9421-C 15 mg was given once daily. | 0 | 25 | 8 | 25 | ||
| EG002 | Placebo | An enteric capsule without D9421-C was given once daily. | 2 | 26 | 6 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Perianal abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Crohn's Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| >=30 years |
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| Male |
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