Crohn's Disease
Conditions
Keywords
gastrointestinal, GI, Crohn's disease, Japan, Japanese
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.
Interventions
DRUGD9421-C, 9mg
D9421-C 9 mg was given once daily for 8 weeks.
DRUGD9421-C, 15mg
D9421-C 15 mg was given once daily for 8 weeks.
DRUGPlacebo
D9421-C matching placebo was given once daily for 8 weeks.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment | Baseline to 2 weeks | 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. |
| Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment | Baseline to 4 weeks | 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. |
| Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method | At 8 weeks | 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. |
| Change in CDAI Score From Baseline to 8 Weeks | 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. |
Countries
Japan
Participant flow
Recruitment details
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.
Pre-assignment details
Patients who had a CDAI score of less than 200 were excluded before randomisation.
Participants by arm
| Arm | Count |
|---|---|
| D9421-C 9 mg An enteric capsule including D9421-C 9 mg was given once daily. | 26 |
| D9421-C 15 mg An enteric capsule including D9421-C 15 mg was given once daily. | 25 |
| Placebo An enteric capsule without D9421-C was given once daily. | 26 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 |
| Overall Study | Other | 5 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | D9421-C 9 mg | D9421-C 15 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Customized <30 years | 8 Participants | 7 Participants | 4 Participants | 19.0 Participants |
| Age, Customized >=30 years | 18 Participants | 18 Participants | 22 Participants | 58.0 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 6 Participants | 22.0 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 20 Participants | 55.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 26 | 8 / 25 | 6 / 26 |
| serious Total, serious adverse events | 2 / 26 | 0 / 25 | 2 / 26 |
Outcome results
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.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9 mg | Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment | 6 Participants |
| D9421-C 15 mg | Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment | 7 Participants |
| Placebo | Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment | 3 Participants |
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.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| D9421-C 9 mg | Change in CDAI Score From Baseline to 8 Weeks | -48 Score on a scale | Standard Deviation 77.5 |
| D9421-C 15 mg | Change in CDAI Score From Baseline to 8 Weeks | -58 Score on a scale | Standard Deviation 84.7 |
| Placebo | Change in CDAI Score From Baseline to 8 Weeks | -27 Score on a scale | Standard Deviation 89.9 |
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.
Time frame: At 8 weeks
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| D9421-C 9 mg | Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method | 38.5 Percentage of participants | 77.7 |
| D9421-C 15 mg | Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method | 36.0 Percentage of participants | 84.7 |
| Placebo | Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method | 19.0 Percentage of participants | 89.9 |
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.
Time frame: Baseline to 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9 mg | Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment | 2 Participants |
| D9421-C 15 mg | Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment | 3 Participants |
| Placebo | Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment | 0 Participants |
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.
Time frame: Baseline to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| D9421-C 9 mg | Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment | 5 Participants |
| D9421-C 15 mg | Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment | 6 Participants |
| Placebo | Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment | 3 Participants |