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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

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 - Comparison of a Gastroprotective Agent and H2-Receptor Antagonist on Preventative and Therapeutic Effects against Gastroduodenal Mucosal Damage in Patients Taking Low-Dose Aspirin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011781
Enrollment
100
Registered
2013-09-18
Start date
2007-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroduodenal ulcer

Interventions

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 the teprenone group (50 mg, three t

Sponsors

Osaka Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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:

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Endoscopy view (existence of ulcer development of symptoms)

Secondary

MeasureTime frame
A LANZA strange method score, subjective symptoms, a blood test (anemic existence), safety

Countries

Japan

Contacts

Public ContactToshihisa Takeuchi

Osaka Medical College 2nd Department of Internal Medicine

in2097@poh.osaka-med.ac.jp0726846432

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026