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

This study is currently recruiting participants.
Verified March 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01514240
First received: January 10, 2012
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is 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.


Condition Intervention Phase
Crohn's Disease
 Drug: D9421-C capsule 3 mg
Drug: Mesalazine tablets
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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 (CD) in Japan

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinical efficacy change 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. [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remission (ie, CDAI score of ≤150) after 2-week treatment [ Time Frame: baseline and Week-2 ] [ Designated as safety issue: Yes ]
  • Remission (ie, CDAI score of ≤150) after 4-week treatment [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Change in CDAI score [ Time Frame: baseline and after 2-week ] [ Designated as safety issue: Yes ]
  • Change in CDAI score [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Change in CDAI score [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: Yes ]
  • Time to the first remission [ Time Frame: up to 8th Week of treatment ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from baseline [ Time Frame: baseline and week-2 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from baseline [ Time Frame: baseline and week-4 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 100 from baseline [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 70 from baseline [ Time Frame: baseline and Week-2 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 70 from baseline [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Clinical improvement defined by a remission (ie, CDAI score of ≤150) or a decrease in CDAI score of at least 70 from baseline [ Time Frame: baseline and week-8 ] [ Designated as safety issue: Yes ]
  • Change in disease specific health-related quality of life (HRQL) as defined by a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores [ Time Frame: baseline and Week-2 ] [ Designated as safety issue: Yes ]
  • Change in disease specific health-related quality of life (HRQL) as defined by a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores [ Time Frame: baseline and Week-4 ] [ Designated as safety issue: Yes ]
  • Change in disease specific health-related quality of life (HRQL) as defined by a score of 180-400 on the CDAI by assessment of the Inflammatory Bowel Disease Questionnaire (IBDQ) total score and all sub scores [ Time Frame: baseline and Week-8 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D9421-C
D9421-C 9 mg once daily
 Drug: D9421-C capsule 3 mg
Patients randomised to D9421-C 9 mg will take 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.
Active Comparator: Mesalazine
Mesalazine 1 g three times a day
 Drug: Mesalazine tablets
Patients randomised to Mesalazine 3 g will take 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.

Detailed Description:

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 (CD) in Japan

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 15 years of age or older
  • Main active disease of the ileal, ileocecal region, and/or ascending colon - - If treated with partial nutrition treatment (≤1200 kcal/day) or if treated with azathioprine (≤2.0 mg/kg/day) or 6-mercaptopurine (≤1.2 mg/kg/day), prior to randomisation until the study completion or discontinuation
  • Ability to read, write and to fill a diary card and HRQL questionnaire Having mild to moderate active Crohn's disease, defined as CDAI score of 180-400 at baseline

Exclusion Criteria:

  • Patient with CD lesion or status which may affect the evaluation of the efficacy (e.g. lesion only in the upper G-I, active anorectal lesion, abscess formation, stenosis, fistulae, ostomy, short bowel or other uncontrolled concomitant disease)
  • Patient who need any concomitant treatment for CD that may affect the assessment for efficacy of the study drug
  • Patient who need any medication which is prohibited due to suspected influence to metabolism of the study drug
  • Patient who is judged to be inadequate to participate in this study from the safety point of view Patient with well-founded doubt about protocol violation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514240

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
Japan
Research Site Not yet recruiting
Nagoya, Aichi, Japan
Research Site Not yet recruiting
Sakura, Chiba, Japan
Research Site Not yet recruiting
Chikushino, Fukuoka, Japan
Research Site Recruiting
Kurume, Fukuoka, Japan
Research Site Not yet recruiting
Sapporo, Hokkaido, Japan
Research Site Not yet recruiting
Nishinomiya, Hyogo, Japan
Research Site Not yet recruiting
Minami-ku, Yokohama, Kanagawa, Japan
Research Site Not yet recruiting
Sendai, Miyagi, Japan
Research Site Not yet recruiting
Suita, Osaka, Japan
Research Site Not yet recruiting
Shinjuku, Tokyo, Japan
Research Site Not yet recruiting
Hiroshima, Japan
Research Site Not yet recruiting
Kanagawa, Japan
Research Site Not yet recruiting
Okayama, Japan
Research Site Not yet recruiting
Osaka, Japan
Research Site Not yet recruiting
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Toshifumi Hibi, Professor, Chairman Department of Internal Medicine, Keio University School of Medicine
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01514240     History of Changes
Other Study ID Numbers: D9423C00001
Study First Received: January 10, 2012
Last Updated: March 22, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
mild to moderate active Crohn's disease
affecting ileum
ileocecal region
ascending colon
score of 180-400 on the CDAI

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013