DyspepsiaNCT05503940
Association of Multiple Medications With the Severity of Dyspepsia
An observational study of Dyspepsia, run by Air Force Military Medical University, China at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- How many people
- 600 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study.
Who may be able to join
- aged ≥18 years old
- Patients who met broad criteria of dyspepsia
Who cannot join
- organ failure defined by Marshall standard
- severe psychiatric illnesses
- suspected or identified bowel obstruction
- known malignancy
- pregnancy or lactation
- unable to provide consent
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu
Xiaojun Huang, M.D.
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710032
Na Liu, M.D.
- Not yet recruiting
Xijing 986 Hospital
Xi'an, Shaanxi, 710032
Jun Wang, M.D.
- Recruiting
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
Yanglin Pan, 13991811225, yanglinpan@hotmail.com
About this study
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.
- Conditions
- Dyspepsia
- Medical subject headings
- Dyspepsia
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with severe dyspepsia judged by patients
Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves
Measured: 1 day
Secondary outcomes (9)
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).
Measured: 1 days
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.
Measured: 1 days
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.
Measured: 1 day
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.
Measured: 6 months
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Number of Participants with other functional gastrointestinal diseases
Other functional gastrointestinal diseases，such as irritable bowel syndrome(IBS) or functional heartburn，etc.
Measured: 1 day
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
Measured: 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503940
- Sponsor's protocol ID
- KY20222180-F-1
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Multiple Medications With the Severity of Dyspepsia
- ClinicalTrials.gov ID
- NCT05503940
- Acronym / sponsor ID
- KY20222180-F-1
- Conditions
- Dyspepsia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥ 18 years old who met broad criteria of dyspepsia were eligible for our study.
Key inclusion criteria (2 listed)
- aged ≥18 years old
- Patients who met broad criteria of dyspepsia
Key exclusion criteria (6 listed)
- organ failure defined by Marshall standard
- severe psychiatric illnesses
- suspected or identified bowel obstruction
- known malignancy
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of patients with severe dyspepsia judged by patients
Time frame: 1 day
Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves
9 secondary outcomes
Global Overall Symptom score (GOSS)
Time frame: 1 days
Functional dyspepsia
Time frame: 1 days
organic upper gastrointestinal (GI) diseases.
Time frame: 1 day
subtypes of functional dyspepsia
Time frame: 6 months
Short Form of Nepean Dyspepsia Index (SF-NDI)
Time frame: 1 day
Hospital anxiety and depression scale
Time frame: 1 day
Quality of Life scores
Time frame: 1 day
Number of Participants with other functional gastrointestinal diseases
Time frame: 1 day
Functional dyspepsia symptom diary (FDSD) score
Time frame: 1 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspepsia, run by Air Force Military Medical University, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanglin Pan (13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with severe dyspepsia judged by patients (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2022.