Clinical trial
A Single-center, Single-blind, Randomized Controlled Clinical Study of Bowel Preparation Before Colonoscopy
Name
DZQH-KYLL-23-11
Description
This study was a single-center, randomized controlled clinical study. Subjects meeting the inclusion criteria will be randomly assigned to magnesium sodium potassium sulfate oral concentrated solution group, magnesium sodium potassium sulfate oral concentrated solution + linaclotide group, PEG group in equal proportion.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Recruiting
Treatment
OSS
experimental
Arms:
Magnesium sulfate sodium potassium solution group
Other names:
Sodium potassium magnesium sulfate oral concentrated solution
OSS+Linzess
experimental
Arms:
Magnesium sulfate sodium potassium solution group + linaclotide group
Other names:
sodium potassium magnesium sulfate oral concentrated solution + linaclotide
PEG-Interferon Alfa
Placebo Comparator
Arms:
PEG (Compound polyethylene glycol electrolyte powder) group
Other names:
PEG
Size
444
Primary endpoint
BBPS
1day
Eligibility criteria
Inclusion Criteria:
* Signed written informed consent;
* Age 18-80 years old, gender is not limited;
* The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
* Non-lactating pregnant women and no pregnancy plan during the test;
* Do not participate in any clinical trials for 3 months before and during the trial;
* Participate voluntarily and sign informed consent.
Exclusion Criteria:
* NYHA cardiac function grade III or IV;
* Unstable angina pectoris in the convalescence period of acute myocardial infarction or in the near future;
* have serious liver and kidney function diseases;
* Suspected gastrointestinal obstruction or gastrointestinal perforation;
* Pregnant or lactating women;
* Mental illness or physical dysfunction can not cooperate with the examination;
* People who are allergic to intestinal preparation drugs.
* Patients who did not undergo colonoscopy after bowel clearing due to their own reasons;
* Patients who can not tolerate general colonoscopy and terminate the examination;
* Patients who requested withdrawal from the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 444, 'type': 'ESTIMATED'}}
Updated at
2023-10-23
1 organization
3 products
1 indication
Organization
Jinling HospitalProduct
OSSIndication
Bowel PreparationProduct
OSS+LinzessProduct
PEG-Interferon Alfa