The Effect of Multiple Medications on the Incidence of Organic Dyspepsia
1 other identifier
observational
500
1 country
4
Brief Summary
Dyspepsia is a very common gastrointestinal disease, presented as predominant symptom of upper abdominal pain. Underlying causes for dyspepsia can classified as organic or functional dyspepsia. Some medications (eg. non-steroid anti-inflammatory drugs (NSAIDs)) were associated with higher frequent incidences of organic lesions. Multiple medications showed an increased trend with aging of the population and multimorbidity. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which had been reported to lead to higher incidences of some diseases, including fractures, cognitive impairment and malnutrition. However, it was unknown if multiple medications was associated with more incidences of organic dyspepsia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 20, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedSeptember 1, 2022
August 1, 2022
1.6 years
August 20, 2022
August 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the rate of patients diagnosed with organic upper gastrointestinal (GI) diseases.
All included patients underwent upper GI endoscopy and abdominal ultrasound and H. Pylori test. Barrett's esophagus, esophageal candidiasis, esophageal cancer, gastric ulcer, gastric erosion, gastric cancer, duodenal ulcer, duodenal erosion, cholecystitis, pancreatitis and biliary stones were classified as organic upper GI diseases.
1 day
Secondary Outcomes (8)
Functional dyspepsia
6 months
Number of participants with different subtypes of functional dyspepsia
6 months
Short Form of Nepean Dyspepsia Index (SF-NDI)
1 day
Hospital anxiety scale
1 day
Hospital depression scale
1 day
- +3 more secondary outcomes
Eligibility Criteria
Patients aged ≥ 18 years old who met broad criteria of dyspepsia with upper endoscopy and abdominal ultrasonography within one year were eligible for our study.
You may qualify if:
- aged ≥18 years old
- patients who met broad criteria of dyspepsia
- undergoing upper endoscopy and abdominal ultrasonography within one year.
You may not qualify if:
- organ failure defined by Marshall standard
- severe psychiatric illnesses
- suspected or identified bowel obstruction
- known malignancy
- pregnancy or lactation
- unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710032, China
Xijing 986 Hospital
Xi'an, Shaanxi, 710032, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 20, 2022
First Posted
September 1, 2022
Study Start
June 1, 2022
Primary Completion
December 31, 2023
Study Completion
June 1, 2024
Last Updated
September 1, 2022
Record last verified: 2022-08