Study on the Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70 Years Old

NCT06652906 · tracked via the Priya Life Science China tracker

Sponsor

RenJi Hospital

Phase

Phase 2

Started

2024-06-11

Last updated

2024-10-22

Condition(s) studied

Physical Examination

Investigational drug(s) / intervention(s)

Sodium phosphate powderPolyethylene glycol electrolyte dispersion

Sodium phosphate powder: After admission, the patient underwent comprehensive renal function and electrolyte tests. The first medication was taken at 7pm the day before the examination. One bag of sodium phosphate powder was diluted with 800ml or more of warm and cool water before taking. The second dose of medication should be taken at 7am on the day of operation or examination (or at least 3 hours before the examination), with the same usage as the first dose, with a 12 hour interval between each dose. The standard dose for each dose is 1 bag, until clear water like stool appears.

Polyethylene glycol electrolyte dispersion: After admission, the patient underwent comprehensive renal function and electrolyte examination. The evening before the intestinal examination, 2000ml of polyethylene glycol electrolyte San III isotonic solution was taken, 250ml every 10-15 minutes, and it was taken within 2 hours. On the day of examination, 2000ml of polyethylene glycol electrolyte San III isotonic solution was taken 3-4 hours in advance until clear water like stool appeared.

Study summary

Project Name: Safety and Efficacy of Sodium Phosphate Powder for Intestinal Preparation in People Aged 50 to 70: A Prospective, Multicenter, Randomized Controlled Clinical Trial The main purpose of the study is to investigate the effectiveness and safety of sodium phosphate powder for intestinal preparation in people aged 50 to 70.

Secondary objective: To study the tolerance of sodium phosphate powder for intestinal preparation in the population aged 50 to 70 years and its impact on The impact of lesion detection. A prospective multicenter intervention randomized controlled clinical study of research design The total number of cases is 362 in the group leader center, with a total of 8 participating centers each having 44 cases.

Treatment plan: Sodium phosphate powder group or Fujingqing group

Main efficacy evaluation indicators:

The effective rate of intestinal preparation, that is, the endoscopist determines that the patient's Boston intestinal preparation score is ≥ 6 points and The ratio of patients with a bowel preparation score of ≥ 2 points per segment to the total number of patients.

Safety evaluation indicators Adverse reaction incidence rate Statistical methods: Numerical variables are described using mean ± standard deviation (Mean ± SD) and estimated using normal distribution method

Analysis of main efficacy indicators:

Based on the intention to treat set, including all qualified patients undergoing colonoscopy, efficacy evaluation will be conducted, Use chi square test or Fisher's exact probability method for inter group comparison. The inspection level is 0.05.

Research period from April 2023 to August 2024

Eligibility

Sex

ALL

Min age

50 Years

Max age

70 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Age 50 to 70 years old, gender unlimited 2. No contraindications for colonoscopy examination, planned to undergo colonoscopy examination in the near future 3. Agree to participate in this study Exclusion Criteria: 1. Patients with a history of colorectal surgery (resection of malignant tumors, resection of rectal perforation, etc.) 2. Electrolyte disorders and hemodialysis patients 3. Patients with active lower gastrointestinal bleeding 4. Patients with abnormal coagulation function 5. Concomitant severe primary diseases such as lung, liver, kidney, and hematopoietic system, liver function ALT AST exceeds the upper limit of the reference value by 1.5 times, or Cr exceeds the upper limit of the reference value 6. Merge other diseases that may affect the efficacy judgment or pose a significant risk, such as acute inflammatory bowel disease, colon cancer, intussusception, volvulus, intestinal obstruction, peritonitis, ascites, stubborn constipation, etc 7. Patients with mental illness and severe neurosis 8. Patients known to have allergies to the investigational or control drugs 9. Participated in other clinical researchers within one month 10. Researchers believe that there are other situations that are not suitable for inclusion, and patients are unwilling to be included in the study

Primary outcome measure(s)

Qualified rate of intestinal preparation — Within three months
According to the Boston intestinal score, the evaluation was completed by a colonoscopy doctor.

Trial sites (1)

Facility	City	Region	Status
Shanghai Jiaotong University School of Medicine, Renji Hospital	Shanghai	Shanghai Municipality	Recruiting

More RenJi Hospital trials in China

The Efficacy of Gallium[68Ga]NOTA-DNA Multivalent SGC8 Injection for Bladder Tumour Imaging Recruiting

Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment Recruiting

Ciprofol vs Propofol for Hemodynamic Stability in Patients Having General Anesthesia for Endovascular Thrombectomy After Ischemic Stroke Starting soon

Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer Recruiting

JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06652906 on ClinicalTrials.gov ↗ ← All trials in China