UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011781
Receipt No. R000011781
Scientific Title Comparison of a Gastroprotective Agent and H2-Receptor Antagonist on Preventative and Therapeutic Effects against Gastroduodenal Mucosal Damage in Patients Taking Low-Dose Aspirin: A prospective, randomized, multicenter, controlled trial
Date of disclosure of the study information 2013/09/18
Last modified on 2013/09/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of a Gastroprotective Agent and H2-Receptor Antagonist on Preventative and Therapeutic Effects against Gastroduodenal Mucosal Damage in Patients Taking Low-Dose Aspirin:
A prospective, randomized, multicenter, controlled trial
Acronym Comparison of a Gastroprotective Agent and H2-Receptor Antagonist on Preventative and Therapeutic Effects against Gastroduodenal Mucosal Damage in Patients Taking Low-Dose Aspirin
Scientific Title Comparison of a Gastroprotective Agent and H2-Receptor Antagonist on Preventative and Therapeutic Effects against Gastroduodenal Mucosal Damage in Patients Taking Low-Dose Aspirin:
A prospective, randomized, multicenter, controlled trial
Scientific Title:Acronym Comparison of a Gastroprotective Agent and H2-Receptor Antagonist on Preventative and Therapeutic Effects against Gastroduodenal Mucosal Damage in Patients Taking Low-Dose Aspirin
Region
Japan

Condition
Condition gastroduodenal ulcer
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 gastroduodenal ulcer induced with low-dose aspirin, teprenone is considered as contrast and comparison examination of the preventive effect of famotidine which is H2 receptor antagonist is carried out clinically.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Endoscopy view (existence of ulcer development of symptoms)
Key secondary outcomes A LANZA strange method score, subjective symptoms, a blood test (anemic existence), safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The subjects were allocated to either the famotidine group (20 mg, once a day)hey were treated with each study medication for 12 weeks while taking LDA continuously
Interventions/Control_2 the teprenone group (50 mg, three times a day.hey were treated with each study medication for 12 weeks while taking LDA continuously
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Not applicable
Gender Male and Female
Key inclusion criteria criteria were that patients required continuous medication with LDA (80&#8211;300 mg/day) for 12 weeks or longer after participation in the study, regardless of past LDA treatment, that they were aged 20 years or older and that no peptic ulcer was detected on endoscopy at the start of treatment. Patients were included regardless of sex and whether or not they were outpatients. Exclusion criteria were as follows:
Key exclusion criteria 1) Patients with peptic ulcer;
2) Patients who had undergone gastrectomy or vagotomy;
3) Patients treated with an H2RA or PPI within the 28 days (four weeks) before the start of study medication administration;
4) Patients treated with a non-steroidal anti-inflammatory drug (NSAID) within 28 days (four weeks) before the start of study medication administration;
5) Patients whose corticosteroid regimen (excluding topical medication) was changed (including the dosage and administration) within 14 days (two weeks) before the start of study medication administration;
6) Patients with a serious liver disorder, a serious renal disorder, a serious cardiac disease, and/or a serious blood dyscrasia;
7) Patients who were allergic to or had experienced an adverse reaction to famotidine or teprenone, which scheduled to be administered;
8) Pregnant or lactating women, or women who might become or intended to become pregnant during the study period;
9) Patients determined by an investigator or a sub-investigator to be ineligible.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide HIguchi
Organization Osaka Medical College
Division name 2nd Department of Internal Medicine
Zip code
Address 2-7Daigaku-machi,Takatsuki Osaka
TEL 0726846432
Email higuchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihisa Takeuchi
Organization Osaka Medical College
Division name 2nd Department of Internal Medicine
Zip code
Address 2-7Daigaku-machi,Takatsuki Osaka
TEL 0726846432
Homepage URL
Email in2097@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization non
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2013 Year 09 Month 18 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
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 17 Day
Last modified on
2013 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011781


Contact us.