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Related Experiment Videos

Protocol design for recent duodenal ulcer maintenance trials.

F N Eshelman, C E Holland

    The American Journal of Medicine
    |November 19, 1984
    PubMed
    Summary

    Ranitidine effectively prevents duodenal ulcer recurrence long-term, showing comparable efficacy to cimetidine in clinical trials. Standardized international research methods ensured reliable safety and efficacy data for ranitidine treatment.

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    Clinical pharmacology and therapeutics·1985

    Area of Science:

    • Gastroenterology
    • Clinical Pharmacology
    • Medical Research Methodology

    Background:

    • Duodenal ulcer recurrence poses a significant clinical challenge.
    • Previous studies on ulcer recurrence prevention had design limitations.
    • Standardization of international clinical research is crucial for reliable drug efficacy data.

    Purpose of the Study:

    • To evaluate the long-term efficacy and safety of ranitidine for preventing duodenal ulcer recurrence.
    • To compare ranitidine with cimetidine and placebo in a standardized international trial setting.
    • To implement robust methodologies for accurate assessment of ulcer recurrence rates.

    Main Methods:

    • Conducted two sets of double-blind, randomized, multicenter clinical trials.
    • Administered ranitidine 150 mg at bedtime, compared with cimetidine 400 mg or placebo.
    • Utilized identical case report forms, central laboratories, and standardized monitoring across all sites.
    • Employed frequent endoscopic examinations and life-table analysis for precise recurrence rate determination.

    Main Results:

    • Ranitidine demonstrated long-term efficacy in preventing duodenal ulcer recurrence.
    • Efficacy of ranitidine was comparable to cimetidine in the studied patient populations.
    • The standardized methodology and life-table analysis provided a more accurate assessment of recurrence than previous crude-rate methods.

    Conclusions:

    • Ranitidine is an effective long-term option for preventing duodenal ulcer recurrence.
    • The study successfully established a standardized international research framework for drug trials.
    • Improved methodological approaches enhance the reliability of findings in gastrointestinal drug efficacy studies.

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