Efficacy and Safety of Sodium, Potassium, and Magnesium Sulfate Oral Solution in Bowel Preparation for Colonoscopy

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate whether sodium, potassium, and magnesium sulfate oral solution used for colon cleaning in adults prior to colonoscopy was not inferior to polyethylene glycol electrolyte powder in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Changhai Hospital
• Collaborators: Beijing Hospital; China-japan Friendship Hospital, Jilin University; First affiliated hospital of Nanchang University; Hebei Provincial People's Hospital; Henan Provincial People's Hospital; Shandong University Qilu Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Hospital of Integrated Traditional Chinese and Western Medicine; Zhongshan Hospital Xiamen University
• Treatments: Magnesium Sulfate

Criteria

Inclusion Criteria:

• Voluntarily participate and sign informed consent;

• Scheduling screening, surveillance, and diagnostic colonoscopy;

• Necessary body fluid and blood electrolyte balance (the test values of potassium, sodium, chlorine, calcium and magnesium in blood biochemistry during screening period should not exceed 10% of the normal range).

Exclusion Criteria:

• Subjects who used drugs that affect gastrointestinal dynamics, affect kidney function, or increase the risk of fluid retention or electrolyte disorders within 7 days before the start of the trial;

• Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, Renal or liver dysfunction;

• Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder or acute gastrointestinal bleeding;

• Subjects with acute severe colitis (such as active severe inflammatory bowel disease, acute bacterial dysentery, diverticulitis, etc.);

• Subjects with a history of major gastrointestinal surgery (e.g. gastric bypass, gastric septal surgery, colostomy, colectomy, etc.);

• Subjects with constipation or suspected severe gastric motility disorder;

• Women with positive pregnancy tests or pregnancy plans, and women in lactation;

• Subjects who have participated in any other clinical trials within the last 3 months;

• Subjects with any other conditions that the investigator considered inappropriate for inclusion.