UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001399 |
|---|---|
| Receipt number | R000001700 |
| Scientific Title | Analysis of the symptom of gastro-esophageal reflux after H. pylori eradication |
| Date of disclosure of the study information | 2008/09/27 |
| Last modified on | 2016/02/20 14:37:12 |
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Basic information
Public title
Analysis of the symptom of gastro-esophageal reflux after H. pylori eradication
Acronym
Analysis of the symptom of gastro-esophageal reflux after H. pylori eradication
Scientific Title
Analysis of the symptom of gastro-esophageal reflux after H. pylori eradication
Scientific Title:Acronym
Analysis of the symptom of gastro-esophageal reflux after H. pylori eradication
Region
| Japan |
Condition
Condition
Patients with H. pylori-positive peptic ulcer disease, who are planned to eradicate H. pylori.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Incidence of gastro-esophageal reflux disease after H. pylori eradication therapy
Basic objectives2
Others
Basic objectives -Others
Symptomatic assessment of gastro-esophageal reflux disease after H. pylori eradication therapy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Gastro-esophageal reflux score (QUEST), QOL score (QOLRAD-J) at 0, 1, 12, 24, 48 weeks after the H. pylori eradication
Key secondary outcomes
Pepsinogen I, pepsinogen II at 0, 3, 6 and 12 months after the H. pylori eradication
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
H. pylori-positive patients with peptic ulver scar.
Key exclusion criteria
1. Hypersensitivity to omeprazole
2. patients taking atazanavir sulfate
3. Patients with severe liver dysfunction or renal dysfunction
4. Expectant mother
5. patients having taken PPIs
6. patients who is decided as not suitable to this study by doctors
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
Medical Education Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3914
hsuzuki.a6@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Keio University School of Medicine
Division name
Medical Education Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3914
Homepage URL
http://web.sc.itc.keio.ac.jp/medicine/other/ugi2/index.html
hsuzuki.a6@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astra-Zeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The relationship between Helicobacter pylori (H. pylori) eradication therapy and the risk of developing gastroesophageal reflux disease (GERD) is controversial. We investigated the influence of H. pylori eradication on the risk of GERD by focusing on the quality of life (QOL) and evaluating reflux symptoms. Patients with H. pylori infection were administered triple therapy for H. pylori eradication. At 3 months and 1 year after the eradication therapy, surveys were conducted to determine the health-related QOL by quality of life in reflux and dyspepsia-Japanese version, (QOLRAD-J) and the severity of GERD symptoms by Carlsson-Dent questionnaire (CDQ). Forty patients were included in the analysis. Although no significant changes of these scores were apparent 3 months after H. pylori eradication, the QOLRAD-J and CDQ scores were significantly improved after 1 year. The degree of improvement was even more marked in cases with initially low scores. In conclusion, improved GERD-related QOL and reflux symptoms were noted 1 year after H. pylori eradication therapy. In addition, the degree of improvement was more marked in cases with severe reflux symptoms.
(J Clin Biochem Nutr. 2013
Mar;52(2):172-8)
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
| 2008 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 09 | Month | 01 | Day |
Other
Other related information
Hirata K, Suzuki H, Matsuzaki J, Masaoka T, Saito Y, Nishizawa T, Iwasaki E,
Fukuhara S, Okada S, Hibi T. Improvement of reflux symptom related quality of
life after Helicobacter pylori eradication therapy. J Clin Biochem Nutr. 2013
Mar;52(2):172-8. doi: 10.3164/jcbn.12-107. Epub 2013 Mar 1. PubMed PMID:
23524980; PubMed Central PMCID: PMC3593136.
Management information
Registered date
| 2008 | Year | 09 | Month | 27 | Day |
Last modified on
| 2016 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001700
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