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Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514240
First Posted: January 23, 2012
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: March 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: D9421-C capsule 3 mg
Drug: Mesalazine tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled on 08 February 2012. Last subject last visit on 08 September 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 123 enrolled subjects, 112 subjects were randomised and 11 subjects were not randomised. The reasons of no randomisation were 'Eligibility criteria not met' (9 subjects) and 'Adverse event' (2 subjects).

Reporting Groups
  Description
D9421-C 9mg + Mesalazine Placebo Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
Mesalazine 3g + D9421-C Placebo Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.

Participant Flow:   Overall Study
    D9421-C 9mg + Mesalazine Placebo   Mesalazine 3g + D9421-C Placebo
STARTED   56   56 
COMPLETED   50   45 
NOT COMPLETED   6   11 
Adverse Event                4                4 
Subject Decision                2                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
D9421-C 9mg + Mesalazine Placebo Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
Mesalazine 3g + D9421-C Placebo Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   D9421-C 9mg + Mesalazine Placebo   Mesalazine 3g + D9421-C Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   56   112 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.1  (13.43)   35.8  (10.71)   36.9  (12.15) 
Age, Customized 
[Units: Participants]
     
<30 Years   19   20   39 
>=30 Years   37   36   73 
Gender 
[Units: Participants]
     
Female   19   13   32 
Male   37   43   80 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   56   55   111 
Black/African American   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Remission After 8-week of Treatment   [ Time Frame: 8 Week ]

2.  Secondary:   Remission After 2-week of Treatment   [ Time Frame: 2 Week ]

3.  Secondary:   Remission After 4-week of Treatment   [ Time Frame: 4 Week ]

4.  Secondary:   Change in Observed CDAI Scores From Baseline to Weeks 2   [ Time Frame: 2 Week ]

5.  Secondary:   Change in Observed CDAI Scores From Baseline to Weeks 4   [ Time Frame: 4 Week ]

6.  Secondary:   Change in Observed CDAI Scores From Baseline to Weeks 8   [ Time Frame: 8 Week ]

7.  Secondary:   Cumulative Remission Rate at Week 2   [ Time Frame: 2 Week ]

8.  Secondary:   Cumulative Remission Rate at Week 4   [ Time Frame: 4 Week ]

9.  Secondary:   Cumulative Remission Rate at Week 8   [ Time Frame: 8 Week ]

10.  Secondary:   Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2   [ Time Frame: 2 Week ]

11.  Secondary:   Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4   [ Time Frame: 4 Week ]

12.  Secondary:   Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8   [ Time Frame: 8 Week ]

13.  Secondary:   Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2   [ Time Frame: 2 Week ]

14.  Secondary:   Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4   [ Time Frame: 4 Week ]

15.  Secondary:   Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8   [ Time Frame: 8 Week ]

16.  Secondary:   Change in Total IBDQ Scores From Baseline to Weeks 2   [ Time Frame: 2 Week ]

17.  Secondary:   Change in Total IBDQ Scores From Baseline to Weeks 4   [ Time Frame: 4 Week ]

18.  Secondary:   Change in Total IBDQ Scores From Baseline to Weeks 8   [ Time Frame: 8 Week ]

19.  Secondary:   Change in Total IBDQ Scores From Baseline to Weeks 10   [ Time Frame: 10 Week ]

20.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function   [ Time Frame: 2 Week ]

21.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function   [ Time Frame: 4 Week ]

22.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function   [ Time Frame: 8 Week ]

23.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function   [ Time Frame: 10 Week ]

24.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom   [ Time Frame: 2 Week ]

25.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom   [ Time Frame: 4 Week ]

26.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom   [ Time Frame: 8 Week ]

27.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom   [ Time Frame: 10 Week ]

28.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function   [ Time Frame: 2 Week ]

29.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function   [ Time Frame: 4 Week ]

30.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function   [ Time Frame: 8 Week ]

31.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function   [ Time Frame: 10 Week ]

32.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 2 - Social Function   [ Time Frame: 2 Week ]

33.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 4 - Social Function   [ Time Frame: 4 Week ]

34.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 8 - Social Function   [ Time Frame: 8 Week ]

35.  Secondary:   Change in IBDQ Scores From Baseline to Weeks 10 - Social Function   [ Time Frame: 10 Week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Masahiro Nii
Organization: Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan
e-mail: Masahiro.Nii@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01514240     History of Changes
Other Study ID Numbers: D9423C00001
First Submitted: January 10, 2012
First Posted: January 23, 2012
Results First Submitted: March 4, 2015
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016