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

Recruiting now · Phase 2

Conditions studied: Physical Examination

In brief

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

Key facts

Study ID: NCT06652906
Run by: RenJi Hospital
People needed: 8
Starts: 2024-06-11
Expected to finish: 2024-12-01
Last updated by the study team: 2024-10-22

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age 50 to 70 years old, gender unlimited
No contraindications for colonoscopy examination, planned to undergo colonoscopy examination in the near future
Agree to participate in this study

You may not qualify if…

Patients with a history of colorectal surgery (resection of malignant tumors, resection of rectal perforation, etc.)
Electrolyte disorders and hemodialysis patients
Patients with active lower gastrointestinal bleeding
Patients with abnormal coagulation function
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
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
Patients with mental illness and severe neurosis
Patients known to have allergies to the investigational or control drugs
Participated in other clinical researchers within one month
Researchers believe that there are other situations that are not suitable for inclusion, and patients are unwilling to be included in the study

Where it is running

Shanghai Jiaotong University School of Medicine, Renji Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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