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Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy

NCT05465889 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2022-07-26

No results posted yet for this study

Summary

To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy

Conditions

  • Bowel Preparation for Colonoscopy

Interventions

DRUG

Oral sulfate solution (OSS)

OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Take 177ml sodium, potassium and magnesium sulfates oral solution (diluted to 480ml) within 30 minutes 14-16 hours before colonoscopy, followed by two doses of 480ml warm water within 1 hour; Repeat the procedure 3-4 hours before colonoscopy.

DRUG

Polyethylene Glycol Electrolyte

Take 1000 ml polyethylene glycol electrolyte solution within 1 hour at 8 p.m. the day before colonoscopy; take 2000 ml polyethylene glycol electrolyte solution within 2 hour 4-6 hours before colonoscopy.

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Hospital of Integrated Traditional Chinese and Western Medicine

    collaborator UNKNOWN

  • China-japan Friendship Hospital, Jilin University

    collaborator UNKNOWN

  • Beijing Hospital

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Zhongshan Hospital Xiamen University

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • Hebei Provincial People's Hospital

    collaborator UNKNOWN

  • Shandong University Qilu Hospital

    collaborator UNKNOWN

  • Changhai Hospital

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2020-01-09
Completion
2020-03-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05465889 on ClinicalTrials.gov