World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 8 August 2016
Main ID:  EUCTR2014-004132-20-Outside-EU/EEA
Date of registration: 28/07/2016
Prospective Registration: Yes
Primary sponsor: AstraZeneca K.K.
Public title: Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japan
Scientific title: A multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan
Date of first enrolment:
Target sample size: 112
Recruitment status: NA
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004132-20
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Japan
Contacts
Name: Clinical Operations Division   
Address:  Grand Front Osaka Tower B, 3-1 530-0011 Ofuka-cho, Kita-ku, Osaka Japan
Telephone: +81677114657
Email: Kazuhiko.Motono@astrazeneca.com
Affiliation:  AstraZeneca K.K.
Name: Clinical Operations Division   
Address:  Grand Front Osaka Tower B, 3-1 530-0011 Ofuka-cho, Kita-ku, Osaka Japan
Telephone: +81677114657
Email: Kazuhiko.Motono@astrazeneca.com
Affiliation:  AstraZeneca K.K.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Female or male =15 years of age
2. Diagnosis of Crohn’s Disease, verified by X-ray, endoscopy or histology
3. Main active disease of the ileal, ileocecal region, and/or ascending colon
4. Signed informed consent has to be obtained from the patient, and patient’s legal representative additively if necessary, prior to conducting any study-related procedures.
5. If patients treated with medication before entry, subjects should fulfil the following criteria:
If treated with partial nutrition treatment (=1200 kcal/day), the treatment has to be on constant calories from 14 days prior to randomisation until the study completion or discontinuation (including tapering period).
If treated with azathioprine (=2.0 mg/kg/day) or 6-mercaptopurine (=1.2 mg/kg/day), the treatment has to be on constant dose from 12 weeks prior to randomisation until the study completion or discontinuation (including tapering period).
6. Ability to read, write and to fill a diary card and HRQL questionnaire as instructed.

For randomisation in the study patients must fulfil all of the following criteria:
7.Having mild to moderate active Crohn’s disease, defined as CDAI score of 180-400 based on the patient’s condition for 7 consecutive days prior to the Visit 2

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 109
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
1. Having ileostomy or pouch and/or colostomy.
2. Having active Crohn’s disease in the rectum and/or anus
3. Having limited active Crohn’s disease in upper gastrointestinal only.
4. Having resection of ileum totalling more than 100 cm.
5. Having previous total gastrectomy.
6. Having a known or suspected systemic infection (eg, HBV, HCV, HIV infection).
7. Other complications such as abscess, obstruction, stricture with proximal dilatation, and/or active fistula.
8. Being candidates for immediate major surgery (including endoscopic treatment, but excluding tooth extraction and cataract surgery) or unlikely to complete the trial due to a poor general condition.
9. Having histological documented gastrointestinal malignancy or high-grade dysplasia within five years prior to randomisation.
10. Having a history of carcinoma (excluding basal and squamous skin cell carcinoma) within five years prior to randomisation.
11. Having uncontrolled diabetes. Patient needs to have his/her diabetes controlled by diet, exercise, and medical treatment and without complications such as neuropathy, nephropaty or retinopathy.
12. Having active peptic disease, such as a verified diagnose of esophagitis, gastric, duodenal ulcers and infectious diarrhea.
13. Having rheumatoid arthritis.
14. Having ankylosing spondylitis.
15. Having parathyroid disease.
16. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis at Visit 1, which, in the opinion of the investigator(s), may put the patient at risk because of his/her participation in the study.
17. Having a clinically relevant renal, hepatic, cardiovascular or psychiatric disease as judged by the investigator.
18. Have received or requiring glucocorticosteroids for any reason, or antibiotics for treatment of Crohn’s Disease (eg, sulfasalazine, metronidazol, and ciprofloxacin), within two weeks prior to randomisation and during study period. Use of topical steroids (eg, nasal steroids, eye drops and steroid ointments) is eligible.
19. Having been administered or requiring Mesalazine (=2251 mg/day) from 14 days before randomisation until the day before the randomisation.
20. Have received infliximab within 8 weeks or adalimumab within 2 weeks prior to randomisation
21. Have received methotrexate, cyclosporine or tacrolimus hydrate within 12 weeks prior to randomisation
22. Have received granulocytapheresis within 4 weeks prior to randomisation
23. Have received immunisation with live viruses (eg, polio) or live bacteria (eg, tubercle bacilli) within 12 weeks prior to randomisation.
24. Requiring concomitant medications listed in Section 5.6.3 during the study period.
25. Being pregnant or breast-feeding. Female patients have to be postmenopausal, surgically sterile or using medically accepted contraceptive measures.
26. Known hypersensitivity to budesonide, other glucocorticosteroids, any of the excipients of D9421-C capsule, salicylate esters such as Mesalazine, salicylates, or salazosulfapyridine.
27. Scheduled to undergo any types of invasive treatment during the course of the study.
28. Have participated in any clinical study involving an investigational product 4 weeks prior to randomisation.
29. Have received any kind of experimental treatment within 12 weeks prior to randomisation eg, studies with new biologicals, surgical procedures in a clinical setting, leukocytapheresis and other experimental procedure.
30. Having previously been randomised in this


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Active Crohn’s Disease
MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Product Name: Entocort
Product Code: D9421-C
Pharmaceutical Form: Capsule
INN or Proposed INN: budesonide
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Pentasa
Pharmaceutical Form: Tablet
INN or Proposed INN: mesalazine
CAS Number: 0000089-57-6
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn’s disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the Crohn’s Disease Activity Index (CDAI) by assessment of the remission after 8-week treatment defined by a CDAI score of =150.
Primary end point(s): The primary efficacy variable is the remission defined as CDAI score of =150. The primary analysis will be based on the FAS and the analysis based on the PPS will also be done as a sensitivity analysis. The patients who dropped out without any remission will be considered as no remission after dropout in this analysis.
Secondary Objective: •To evaluate clinical efficacy of D9421-C compared to Mesalazine to patients with mild to moderate active Crohn’s disease affecting ileum, ileocecal region and/or ascending colon as defined by a score of 180-400 on the CDAIby assessment of the following variables:
- Remission (ie, CDAI score of =150) rate after 2-week and 4-week treatment
- Change in CDAI score
- Time to the first remission
- Clinical improvement defined by a remission (ie, CDAI score of =150) or a decrease in CDAI score of at least 100 from Visit 2 after 2-week, 4-week, and 8-week treatments

•To evaluate the change in disease specific health-related quality of life (HRQL) of D9421-C compared to Mesalazine to patients with mild to moderate active Crohn’s disease

•To evaluate the overall safety of D9421-C compared to Mesalazine to patients with mild to moderate active Crohn’s disease
Timepoint(s) of evaluation of this end point: after 8-week treatment
Secondary Outcome(s)
Secondary end point(s): 1. Remission rate after treatment
2. CDAI scores at Visit 2 onwards and the changes from Visit 2
3. Time to remission defined as the number of days from the randomisation
4. Clinical improvement rate assesed by CDAI score
-CDAI score of =150 or a decrease in CDAI score of at least 100 from Visit 2
-CDAI score of =150 or a decrease in CDAI score of at least 70 from Visit 2.
5. The canges of IBDQ scores
6. Safety variables
(a )Adverse events
(b)Clinical Laboratory variables
(c)Vital signs
Timepoint(s) of evaluation of this end point: 1. 2-week and 4-week after randomization
2. at Visit 2 and the visits at post-dose
3. the day when the first remission is obtained
4. at Weeks 2, 4 and 8 after randomization
5. at baseline, Weeks 2, 4, 8 and 10
6. Safety variables
(a) during study period.
(b) at baseline, Weeks 2, 4, 8 and 10
(c) at baseline, Weeks 2, 4, 8 and 10
Secondary ID(s)
D9423C00001
NCT01514240
Source(s) of Monetary Support
Astrazeneca KK
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history