Association of Multiple Medications With the Severity of Dyspepsia
1 other identifier
observational
600
1 country
4
Brief Summary
Dyspepsia is a very common gastrointestinal disease. Some medications, were associated with higher frequent incidences of dyspepsia, including non-steroid anti-inflammatory drugs (NSAIDs), Bisphosphonates, Tetracyclines, et al. 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 may cause gastrointestinal(GI) dysfunction or injury to the GI mucosa. However, it was unclear whether multiple medications was associated with more severe symptoms of dyspepsia and dyspepsia-based score systems.
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 15, 2022
CompletedFirst Posted
Study publicly available on registry
August 17, 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 2, 2022
August 1, 2022
1.6 years
August 15, 2022
August 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of patients with severe dyspepsia judged by patients
Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves
1 day
Secondary Outcomes (9)
Global Overall Symptom score (GOSS)
1 days
Functional dyspepsia
1 days
organic upper gastrointestinal (GI) diseases.
1 day
subtypes of functional dyspepsia
6 months
Short Form of Nepean Dyspepsia Index (SF-NDI)
1 day
- +4 more secondary outcomes
Eligibility Criteria
Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study.
You may qualify if:
- aged ≥18 years old
- Patients who met broad criteria of dyspepsia
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 15, 2022
First Posted
August 17, 2022
Study Start
June 1, 2022
Primary Completion
December 31, 2023
Study Completion
June 1, 2024
Last Updated
September 2, 2022
Record last verified: 2022-08