Guideline Recommendation for Endpoints Used in Clinical Trials for Functional Dyspepsia

Han Hee Lee, Hye Kyung Jung, Myung Gyu Choi

Research output: Contribution to journalReview articlepeer-review

4 Scopus citations

Abstract

Functional dyspepsia is a disease, in which there is no organic lesion but chronic and repetitive postprandial fullness, early satiation, epigastric pain, and epigastric burning. Functional dyspepsia is not life-threatening but its symptoms are relapsing and remitting and persist over a lifetime, limiting the social life and reducing the quality of life. Therefore, the treatment for acute relapsing period may help improve the short-term symptoms. Continuous medication may be needed to improve the long-term symptoms. Research designs to demonstrate the short-term efficacy of therapeutic agents may differ from clinical trials to demonstrate long-term efficacy. There are many difficulties in clinical trial design, implementation, and screening because there are no international standards of clinical trials for functional dyspepsia. The purpose of this guideline recommendation is to develop a standard for clinical trials, such as clinical trial subjects and evaluation methods, in the development of therapeutic agents for functional dyspepsia. The ultimate aim is to enhance the safety and efficacy of therapeutic agents for functional dyspepsia and promote the development of new therapeutic agents.

Original languageEnglish
Pages (from-to)170-178
Number of pages9
JournalThe Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi
Volume72
Issue number4
DOIs
StatePublished - 25 Oct 2018

Keywords

  • Clinical trial
  • Dyspepsia
  • Endpoint determination
  • Gastrointestinal diseases
  • Patient reported outcome measures

Fingerprint

Dive into the research topics of 'Guideline Recommendation for Endpoints Used in Clinical Trials for Functional Dyspepsia'. Together they form a unique fingerprint.

Cite this