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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007579
Receipt No. R000008948
Scientific Title Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF)
Date of disclosure of the study information 2012/03/27
Last modified on 2015/05/18

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Basic information
Public title Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF)
Acronym Dabigatran Dyspepsia Dialogue
Scientific Title Investigation of the incidence, severity, and treatment of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation (NVAF)
Scientific Title:Acronym Dabigatran Dyspepsia Dialogue
Region
Japan

Condition
Condition Non-valvular atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Part 1: To investigate the incidence and severity of dabigatran-related dyspepsia symptoms in patients with non-valvular atrial fibrillation using a prospective observational design.
Part 2: To investigate the therapeutic effect and safety of proton pump inhibitors, H2 receptor antagonists, and gastric mucosal protective drugs using an open-label, randomized, parallel-group, comparative design, in patients who have experienced dyspepsia symptoms with GOS (Global Overall Severity) scale score of 3 or higher during the observational phase of the study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Severity of dyspepsia symptoms during the observational phase of the study
- Improvement rate of dyspepsia symptoms
Key secondary outcomes - Percentage of patients with improvement in the severity of dyspepsia symptoms by two points or more on the GOS scale
- Percentage of patients with resolution of dyspepsia symptoms (i.e., percentage of patients with improvement in the severity to a GOS scale score of 1)
- Percentage of patients with improvement in dyspepsia symptoms (i.e., percentage of patients who still have their main dyspepsia symptoms, but with improvement in the severity to a GOS scale score of 1 or 2)
- Post-treatment severity of dyspepsia symptoms compared with baseline (i.e., change in the GOS scale score from baseline)
- Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of a proton pump inhibitor
Interventions/Control_2 Administration of an H2 receptor antagonists
Interventions/Control_3 Administration of a gastric mucosal protective drug
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria for Part 1
Patients who meet all of the following criteria will be included in Part 1 of the study:
1. Have non-valvular atrial fibrillation (paroxysmal, persistent, or permanent) (inpatients or outpatients)
2. Planned to be started on dabigatran therapy for prevention of ischemic stroke and systemic embolism associated with non-valvular atrial fibrillation
3. Do not have any dyspepsia symptoms (dyspepsia, upper abdominal pain, abdominal pain, abdominal discomfort, or epigastric discomfort)
4. Aged 20 years or older at the time of consent
5. Capable of providing written consent in person to participate in the study

Inclusion criteria for Part 2
Participants of Part 1 who meet all of the following criteria will proceed to Part 2 of the study:
1. Receiving dabigatran for prevention of ischemic stroke and systemic embolism associated with non-valvular atrial fibrillation
2. Have experienced dyspepsia symptoms (dyspepsia, upper abdominal pain, abdominal pain, abdominal discomfort, and/or epigastric discomfort) with GOS (Global Overall Severity) scale score of 3 or higher during Part 1 of the study
Key exclusion criteria Patients who meet any of the following criteria will be excluded from the study:
1. Have a history of hypersensitivity to any ingredients of the dabigatran preparation
2. Undergoing dialysis or have severe renal disorder (creatinine clearance < 30 mL/min*1)
3. Have hemorrhagic symptoms, hemorrhagic diathesis, or hemostatic disturbance
4. Have any organic lesion posing a clinically significant risk for bleeding (including onset of hemorrhagic stroke within the past 6 months)
5. Have a spinal/epidural catheter in place
6. Receiving (oral) itraconazole
7. Have undergone surgery for upper gastrointestinal tract (e.g., esophageal, gastric) resection or vagotomy
8. Have any organic disease confirmed by upper gastrointestinal endoscopy or X-ray performed within one year prior to the consent
9. Women with established or possible pregnancy, nursing mothers, or women who desire to become pregnant during the study participation
10. Other patients judged by the attending physician to be inappropriate as subjects

Patients who meet any of the following criteria will be excluded from Part 2 of the study:
1. Receiving proton pump inhibitors, H2 receptor antagonists, or rebamipide (Mucosta)
2. Have a history of hypersensitivity to any ingredients of the study drug for dyspepsia symptoms, thus precluding administration of the study treatment
3. Have severe renal disorder (creatinine clearance < 30 mL/min*1)
4. Have dyspepsia symptoms that are apparently due to causative factors other than dabigatran, such as overdrinking, overeating, abrupt stress, or concomitant medication
5. Have experienced upper gastrointestinal bleeding or gastric/duodenal ulcerative disease during Part 1 of the study
6. Have concurrent gastroesophageal reflux disease confirmed by endoscopy or X-ray performed during Part 1 of the study
7. Other patients judged by the attending physician to be inappropriate as subjects
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yamashita
Organization Cardiovascular Institute Hospital
Division name Director
Zip code
Address 3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization 3D -Study Secretariat
Division name Research Promotion Group, Mebix Inc.
Zip code
Address 1-11-44 Akasaka, Minato-ku, Tokyo
TEL 03-6229-8936
Homepage URL
Email dabi-dyspepsia@mebix.co.jp

Sponsor
Institute Committee on Proper Use of Anticoagulant Therapies
Institute
Department

Funding Source
Organization The Waksman Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 27 Day
Last modified on
2015 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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