Who is sponsoring NCT04786795?

NCT04786795 is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.

What drugs are being tested in NCT04786795?

Interventions in NCT04786795: Compound Azintamide Enteric-coated Tablets, Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets.

What condition does NCT04786795 study?

NCT04786795 studies Patients With Dyspeptic Symptoms After Cholecystectomy.

Is NCT04786795 still recruiting?

NCT04786795 is currently status unknown. Last updated 3 March 2021.

Last reviewed 2021-03-03 · How we verify

NCT04786795

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

MITE (Compound Azintamide Enteric-coated Tablets) in the Treatment of Dyspepsia After Cholecystectomy: a Multicenter, Randomized, Superior, Parallel Controlled Clinical Study

Status unknown Phase 4 Last updated 3 March 2021

What this trial tests

Phase 4 trial testing Compound Azintamide Enteric-coated Tablets in Patients With Dyspeptic Symptoms After Cholecystectomy in 990 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
1 February 2022

1 February 2022

Quick facts

Lead sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	990
Start date	1 March 2021
Primary completion	1 February 2022
Estimated completion	1 February 2022

Drugs / interventions tested

Compound Azintamide Enteric-coated Tablets — full drug profile →
Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets — full drug profile →

Conditions studied

Patients With Dyspeptic Symptoms After Cholecystectomy — all drugs for Patients With Dyspeptic Symptoms After Cholecystectomy →

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 70, any sex, with Patients With Dyspeptic Symptoms After Cholecystectomy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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%. W

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04786795 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Last refreshed: 3 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04786795.

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