UMIN-CTR Clinical Trial

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

gastroduodenal ulcer

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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 (80–300 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

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

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

Institute

Osaka Medical College

Institute

Department

Personal name

Organization

non

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

09

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

09

Month

17

Day

Last modified on

2013

Year

09

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011781