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

NCT05465889 | Completed Phase 3 DMC

• 1 other identifier: SPMS oral solution
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colonoscopy; Bowel preparation; Sodium Potassium and Magnesium Sulfate; polyethylene glycol

Outcome Measures

Primary Outcomes (1)

• Bowel preparation adequate rate

  Proportion of subjects with total Boston bowel preparation scale (BBPS) score (total colon) ≥6.

  30 minutes

Secondary Outcomes (4)

• Boston bowel preparation scale (BBPS) score

  30 minutes

• Acceptability of laxatives by questionnaire survey

  12 hours

• Colonoscopy completion rate

  30 minutes

• Incidence of laxative-related adverse events assessed by clinical examinations

  8 days

Study Arms (2)

OSS group

EXPERIMENTAL

Bowel preparation for colonoscopy was performed using oral sulfate solution as laxative

Drug: Oral sulfate solution (OSS)

Polyethylene glycol group

ACTIVE COMPARATOR

Bowel preparation for colonoscopy was performed using polyethylene glycol as laxative

Drug: Polyethylene Glycol Electrolyte

Interventions

Oral sulfate solution (OSS) DRUG

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.

OSS group

Polyethylene Glycol Electrolyte DRUG

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.

Polyethylene glycol group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• China-japan Friendship Hospital, Jilin University: collaborator
• Beijing Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Zhongshan Hospital Xiamen University: collaborator
• Henan Provincial People's Hospital: collaborator
• Hebei Provincial People's Hospital: collaborator
• Shandong University Qilu Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, China

Location

Related Publications (3)

• Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.

  PMID: 28648575 BACKGROUND

• Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.

  PMID: 25239068 BACKGROUND

• Pan P, Zhao S, Wang S, Song Y, Gu L, Chen Y, Zhao J, Lu L, Li X, Xu H, Liu G, Li Y, Xu L, Wang J, Li Z, Bai Y. Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial. Gastrointest Endosc. 2023 Dec;98(6):977-986.e14. doi: 10.1016/j.gie.2023.06.070. Epub 2023 Jul 6.

  PMID: 37422241 DERIVED

MeSH Terms

Interventions

glycoprep

Study Officials

• li.zhaoshen@hotmail.com li.zhaoshen@hotmail.com, M.D.

  Changhai Hospital, Naval Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: July 20, 2022
• Study Start: May 15, 2019
• Primary Completion: January 9, 2020
• Study Completion: March 15, 2020
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)