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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001759
Receipt No. R000002117
Scientific Title Double blind, randomized Placebo-controlled study for FD
Date of disclosure of the study information 2009/07/01
Last modified on 2014/05/09

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Basic information
Public title Double blind, randomized Placebo-controlled study for FD
Acronym KFD
Scientific Title Double blind, randomized Placebo-controlled study for FD
Scientific Title:Acronym KFD
Region
Japan

Condition
Condition functional dyspepsia
Classification by specialty
Medicine in general Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of anti-secretory drug in functional dyspepsia by double-blind, randomized, placebo-controlled trials
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Severity of dyspeptic symptoms by symptomatic scale and GSRS
Key secondary outcomes Patients' background
anti-H. pylori IgG

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 anti-secretory drug
Interventions/Control_2 placebo
Interventions/Control_3
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 Patients with functional dyspepsia
Key exclusion criteria Patients with organic disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Suzuki, M.D., Ph.D.
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3914
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Tomotsugu, Ph.D.
Organization Keio University School of Medicine
Division name Center for Clinical Research
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL 03-5363-3288
Homepage URL
Email naokit@sc.itc.keio.ac.jp

Sponsor
Institute Office of the ELF study
Institute
Department

Funding Source
Organization Donation
Organization
Division
Category of Funding Organization Self funding
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
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://ueg.sagepub.com/content/1/6/445.full
Number of participants that the trial has enrolled
Results
Background: Since the publication of the Rome III criteria for functional dyspepsia (FD), the evidence about the efficacy of half-dose of proton pump inhibitors for dyspepsia symptoms have been limited. 

Objective: To examine the efficacy of lansoprazole for functional dyspepsia (FD) diagnosed with the Rome III criteria by the multicentre, double-blind, randomized, placebo-controlled study in Japan. 

Methods: A total of 54 FD participants were randomized to lansoprazole 15&#8201;mg once daily or placebo for a 4-week double-blind treatment period. The primary efficacy endpoint was an overall dyspeptic symptom relief rate evaluated by 5-point Likert scale scores. The alteration of dyspeptic symptom scores during the study period was also assessed. 

Results: At week 4, the overall dyspeptic symptom relief rates were higher in the lansoprazole group (30.4%) than in the placebo group (6.7%) (p&#8201;=&#8201;0.045). The scores for epigastric pain (p&#8201;=&#8201;0.045) and epigastric burning (p&#8201;=&#8201;0.03) were significantly improved in the lansoprazole group compared to the placebo group, whereas the improvement of the scores for postprandial fullness (p&#8201;=&#8201;0.81) and early satiation (p&#8201;=&#8201;0.33) was not different between lansoprazole and placebo groups. 

Conclusions: Lansoprazole 15 mg ameliorates dyspeptic symptoms, particularly the epigastric pain syndrome-related symptoms of FD. 
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
2010 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
2011 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 06 Day
Last modified on
2014 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002117

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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