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

NCT06652906 | Recruiting Phase 2

• 1 other identifier: LY-2024-062-B
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Physical Examination

Outcome Measures

Primary Outcomes (1)

• Qualified rate of intestinal preparation

  According to the Boston intestinal score, the evaluation was completed by a colonoscopy doctor.

  Within three months

Study Arms (2)

Sodium phosphate powder group

EXPERIMENTAL

Sodium phosphate powder group: After admission, patients will undergo comprehensive renal function and electrolyte tests. The first medication will be taken at 7pm the day before the examination. One bag of sodium phosphate powder will be 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.

Drug: Sodium phosphate powder

Polyethylene glycol electrolyte dispersion

ACTIVE COMPARATOR

Polyethylene glycol electrolyte powder group: After admission, the patient underwent comprehensive renal function and electrolyte examination. The evening before the intestinal examination, 2000ml of polyethylene glycol electrolyte powder 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 powder III isotonic solution was taken again 3-4 hours in advance until clear water like stool appeared.

Drug: Polyethylene glycol electrolyte dispersion

Interventions

Sodium phosphate powder DRUG

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.

Sodium phosphate powder group

Polyethylene glycol electrolyte dispersion DRUG

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.

Also known as: Fortrans

Polyethylene glycol electrolyte dispersion

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Peng Yan

CONTACT

15851894867; yp122333@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: October 22, 2024
• Study Start: June 11, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)