Association of Multiple Medications With the Severity of Dyspepsia

Dyspepsia Clinical Trial

Official title:

Association of Multiple Medications With the Severity of Dyspepsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503940
• Other study ID #: KY20222180-F-1
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2022
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan
• Phone: 13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged =18 years old

2. Patients who met broad criteria of dyspepsia

Exclusion Criteria:

1. organ failure defined by Marshall standard

2. severe psychiatric illnesses

3. suspected or identified bowel obstruction

4. known malignancy

5. pregnancy or lactation

6. unable to provide consent

Related Conditions & MeSH terms

• Dyspepsia

Locations

Country	Name	City	State
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing 986 Hospital	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Global Overall Symptom score (GOSS)	The GOSS consists of 10 cardinal items (epigastric pain, epigastric discomfort, Heartburn, acid regurgitation, upper abdominal bloating, belching, nausea, early satiety, postprandial fullness, other epigastric symptoms(eg. epigastric burning). Each item can be scored from 1 (no) to 7 (worst).	1 days
Secondary	Functional dyspepsia	Functional dyspepsia was defined by Rome IV criteria. Patients diagnosed as Rome IV criteria met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.	1 days
Secondary	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	subtypes of functional dyspepsia	functional dyspepsia was classified into three subgroups:(1) Postprandial Distress Syndrome, defined as Bothersome postprandial fullness or/and Bothersome early satiation. (2) Bothersome epigastric pain AND/OR Bothersome epigastric burning. (3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously.	6 months
Secondary	Short Form of Nepean Dyspepsia Index (SF-NDI)	The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.	1 day
Secondary	Hospital anxiety and depression scale	Anxiety and depression of patients are assessed by using Hospital Anxiety and Depression Scale.It contains 14 items (7 anxiety and 7 depression), which assess symptoms experienced during the past week on a 0-3 scale. A subscore of > 8 for depression or anxiety would indicate a clinical case.	1 day
Secondary	Quality of Life scores	Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionnaire.PROMIS Global-10 is a newly validated 10-question survey used to assess health care-related quality of life measures for the general population.; It's a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient and a better quality of life.	1 day
Secondary	Number of Participants with other functional gastrointestinal diseases	Other functional gastrointestinal diseases,such as irritable bowel syndrome(IBS) or functional heartburn,etc.	1 day
Secondary	Functional dyspepsia symptom diary (FDSD) score	The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50	1 days