Patients With Dyspeptic Symptoms After CholecystectomyPhase 4NCT04786795
MITE in the Treatment of Dyspepsia After Cholecystectomy
A Phase 4 study testing Compound Azintamide Enteric-coated Tablets and Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets in people with Patients With Dyspeptic Symptoms After Cholecystectomy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
To confirm the clinical efficacy of Compound Azintamide Enteric-coated Tablets in the treatment of patients with dyspepsia after cholecystectomy (such as abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite, etc.) by comparing with positive control… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With Dyspeptic Symptoms After Cholecystectomy
- What is being tested?
- Compound Azintamide Enteric-coated Tablets and Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 990 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to Feb 2022
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years old, male or female;
- Patients after laparoscopic cholecystectomy, mainly including cholecystectomy due to cholecystitis, gallstones, gallbladder polyps and other benign gallbladder tumors, non-functioning gallbladder;
- Dyspeptic symptoms occurred 2 weeks after laparoscopic cholecystectomy, including: abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite;
- Signed informed consent, agreed to participate in this study.
Who cannot join
- Patients with abnormal liver function and renal function;
- Patients with severe heart and lung dysfunction;
- Patients with neurological, mental illness or other reasons can not cooperate with the study;
- Patients with advanced malignant tumors or other serious wasting diseases, any unstable chronic diseases and acute diseases, interfere with the efficacy evaluation of this study (such as patients undergoing chemotherapy) and the completion of the trial plan;
- Patients with biliary obstruction, acute hepatitis, etc., do not use the test drugs and control drugs, and allergic to the test drugs and control drugs;
- Patients who have taken digestive enzymes and cholagogue drugs by themselves;
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- Pregnant and lactating women;
- Patients who are participating in other clinical trials;
- Patients who cannot be followed up on time.
- Elimination Criteria
- Failure to take medicine as required, that is,Failure to take medicine or missed doses ≥ 3 times within 1week;
- Taking other digestive enzymes, cholagogues and prokinetic drugs or drugs affecting digestive enzymes and bile secretion and excretion during the study;
- Adverse events occur, for the benefit of patients, doctors believe that the drug should not be continued; the results of such cases do not participate in the efficacy statistics, but are related to the safety evaluation.
- Drop-out Criteria
- Cases with adverse events and patients are not willing to continue participating in the study.
- Cases who voluntarily withdrew consent from the study due to poor efficacy and inconvenience in follow-up.
- cases lost to follow-up due to various reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: MITE (Compound Azintamide Enteric-coated Tablets) in the Treatment of Dyspepsia After Cholecystectomy: a Multicenter, Randomized, Superior, Parallel Controlled Clinical Study
To confirm the clinical efficacy of Compound Azintamide Enteric-coated Tablets in the treatment of patients with dyspepsia after cholecystectomy (such as abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite, etc.) by comparing with positive control drug, to observe its safety, and to evaluate the quality of life of subjects before and after treatment
Read the detailed description
This study is a multi-center, randomized, superiority and parallel controlled clinical study. Third-party institutions will generate random codes according to random numbers of the software and divide them into two groups (Compound Azintamide Enteric-coated Tablets Group, Oryz-aspergillus Enzyme and Pancreatin Tablet and Ursodeoxycholic Acid Tablets Group) in a ratio of 1:1. Random numbers will be sealed and stored in radiopaque envelopes, which will be managed by a designated person not involved in the specific study.
Specific intervention measures: If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets, and the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
- Being tested
- Compound Azintamide Enteric-coated Tablets, Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound Azintamide Enteric-coated TabletsDrug
the experimental group takes Compound Azintamide Enteric-coated Tablets.They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid TabletsDrug
the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| Compound Azintamide Enteric-coated Tablets | Experimental | If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit. Receives: Drug: Compound Azintamide Enteric-coated Tablets |
| Oryz-aspergillus Enzyme | Placebo comparator | If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit. Receives: Drug: Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom assessment
scored according to the severity of symptoms. severity: 0 : asymptomatic.
- : The patient can recall symptoms only after being reminded.
- : There are symptoms, but it does not affect daily life. 3 points: Symptoms are present, affecting daily life.
Measured: 28days
Efficacy evaluation
symptom score improvement rate = (symptom score before treatment - symptom score after treatment)/symptom score before treatment × 100%.
Significantly effective: symptom score improvement rate > 75%. Effective: symptom score improvement rate 50% ~ 75% (including 50%). Improvement: symptom score improvement rate of 25% ~ 50% (including 25%). Ineffective: symptom score improvement rate < 25%. Worsening: The symptom score increased after medication. Overall response rate = (number of effective cases + number of significantly effective cases)/total number of cases × 100%.
Measured: 28days
Secondary outcomes (3)
The incidence of adverse events (AE)
Serious adverse events (SAE), such as death or life-threatening, hospitalization or prolonged hospitalization, severe disability or severely impaired organ function, etc. Adverse reaction symptoms are recorded in three levels: mild, moderate and severe, and may be related, may not be related, definitely related, and definitely not related. Mild adverse reactions: The symptoms of adverse reactions are mild and can only be remembered after a doctor's inquiry; severe adverse reactions: the main complaints of adverse reactions are strong, affecting the patient's daily life or the continuation of research; moderate adverse reactions: the severity of adverse reactions is moderate Between degree and severe.
Adverse reactions include any new complaints of discomfort during the study period. If symptoms only worsen during the study, it is not considered an adverse event. Any adverse events should be actively handled
Measured: 28days
Quality of life assessment
The SF-NDI scale was used to assess the impact of dyspeptic symptoms on the quality of life of subjects before and after treatment
Measured: 28days
Pharmacoeconomic evaluation
Pharmacoeconomics includes cost indicators and pharmacoeconomic evaluation indicators that are ultimately used for analysis. Cost indicators include the total direct costs that patients should bear from the start of enrollment to the 28-day follow-up period. From an individual analysis perspective, they include: 1) laboratory inspection costs; 2) medical care and management costs; 3) disease diagnosis costs; 4) The cost of treatment; 5) The cost of treatment of adverse reactions and complications.
Pharmacoeconomics evaluation indicators use cost-effectiveness analysis (CEA) to calculate the cost-effectiveness ratio for comparison.
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Dyspeptic Symptoms After CholecystectomyStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786795
- Sponsor's protocol ID
- XHEC-C-2020-049-2
- Status last verified
- Jan 2021
- First submitted
- 24 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MITE (Compound Azintamide Enteric-coated Tablets) in the Treatment of Dyspepsia After Cholecystectomy: a Multicenter, Randomized, Superior, Parallel Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04786795
- Acronym / sponsor ID
- XHEC-C-2020-049-2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 8 Mar 2021 (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.
To confirm the clinical efficacy of Compound Azintamide Enteric-coated Tablets in the treatment of patients with dyspepsia after cholecystectomy (such as abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite, etc.) by comparing with positive control drug, to observe its safety, and to evaluate the quality of life of subjects before and after treatment
Detailed description
This study is a multi-center, randomized, superiority and parallel controlled clinical study. Third-party institutions will generate random codes according to random numbers of the software and divide them into two groups (Compound Azintamide Enteric-coated Tablets Group, Oryz-aspergillus Enzyme and Pancreatin Tablet and Ursodeoxycholic Acid Tablets Group) in a ratio of 1:1. Random numbers will be sealed and stored in radiopaque envelopes, which will be managed by a designated person not involved in the specific study.
Specific intervention measures: If dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets, and the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compound Azintamide Enteric-coated Tablets | Experimental | Drug: Compound Azintamide Enteric-coated TabletsIf dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the experimental group takes Compound Azintamide Enteric-coated Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit. |
| Oryz-aspergillus Enzyme | Placebo comparator | Drug: Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid TabletsIf dyspeptic symptoms occur after laparoscopic cholecystectomy and are randomized, the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-70 years old, male or female;
- Patients after laparoscopic cholecystectomy, mainly including cholecystectomy due to cholecystitis, gallstones, gallbladder polyps and other benign gallbladder tumors, non-functioning gallbladder;
- Dyspeptic symptoms occurred 2 weeks after laparoscopic cholecystectomy, including: abdominal distension, abdominal pain/abdominal discomfort, diarrhea/fatty stool, early satiety, belching, loss of appetite;
- Signed informed consent, agreed to participate in this study.
Key exclusion criteria (17 listed)
- Patients with abnormal liver function and renal function;
- Patients with severe heart and lung dysfunction;
- Patients with neurological, mental illness or other reasons can not cooperate with the study;
- Patients with advanced malignant tumors or other serious wasting diseases, any unstable chronic diseases and acute diseases, interfere with the efficacy evaluation of this study (such as patients undergoing chemotherapy) and the completion of the trial plan;
- Patients with biliary obstruction, acute hepatitis, etc., do not use the test drugs and control drugs, and allergic to the test drugs and control drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compound Azintamide Enteric-coated Tabletsthe experimental group takes Compound Azintamide Enteric-coated Tablets.They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit | Drug | Compound Azintamide Enteric-coated Tablets |
| Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tabletsthe control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit | Drug | Oryz-aspergillus Enzyme |
Primary outcome
Symptom assessment
Time frame: 28days
scored according to the severity of symptoms. severity: 0 : asymptomatic. 1. : The patient can recall symptoms only after being reminded. 2. : There are symptoms, but it does not affect daily life. 3 points: Symptoms are present, affecting daily life.
Efficacy evaluation
Time frame: 28days
symptom score improvement rate = (symptom score before treatment - symptom score after treatment)/symptom score before treatment × 100%. Significantly effective: symptom score improvement rate > 75%. Effective: symptom score improvement rate 50% ~ 75% (including 50%). Improvement: symptom score improvement rate of 25% ~ 50% (including 25%). Ineffective: symptom score improvement rate < 25%. Worsening: The symptom score increased after medication. Overall response rate = (number of effective cases + number of significantly effective cases)/total number of cases × 100%.
3 secondary outcomes
The incidence of adverse events (AE)
Time frame: 28days
Quality of life assessment
Time frame: 28days
Pharmacoeconomic evaluation
Time frame: 28days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Compound Azintamide Enteric-coated Tablets and Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets in people with Patients With Dyspeptic Symptoms After Cholecystectomy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 4 inclusion and 17 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 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 zhaohui tang, PhD (13601789458, tangzhaohui@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom assessment (time frame: 28days). The study lists 2 primary outcomes in all. 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 8 Mar 2021.