NCT03520361

Brief Summary

For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of elderly people, investigators compare the efficacy, tolerability and safety between OSS and 2L polyethylene glycol (PEG) with ascorbic acid (Asc).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

1.5 years

First QC Date

August 20, 2017

Last Update Submit

June 18, 2018

Conditions

Colonoscopy

Keywords

ColonoscopyBowel preparationOral sulfate solutionPolyethylene glycolAscorbic acid

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS)

    The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment.

    3 months

Secondary Outcomes (21)

  • Subject's satisfaction based on the 10-point visual analog scale

    3 months

  • Number of subjects who have a difficulty taking solution based on the 5-grade scale

    3 months

  • Taste of recommended bowel preparation agent based on the 5-grade scale

    3 months

  • Number of subjects who have a willingness to repeat the same regimen

    3 months

  • Rate of subjects with nausea

    3 months

  • +16 more secondary outcomes

Study Arms (2)

Oral sulfate solution (OSS) taking group

EXPERIMENTAL

On the evening before colonoscopy, drink 177ml of OSS (Suclear®) (473ml including water in container), additionally allow another 946 ml of water. On the day of colonoscopy, drink 177ml of OSS (473ml including water in container), additionally allow another 946 ml of water.

Drug: Oral sulfate solution (OSS)

2L PEG/Asc taking group

ACTIVE COMPARATOR

On the evening before colonoscopy, drink 1L of 2L PEG/Asc (Haprep®) solution, additionally allow another 500 ml of water. On the day of colonoscopy, drink 1L of 2L PEG/Asc solution, additionally allow another 500 ml of water.

Drug: 2L PEG/Asc

Interventions

Oral sulfate solution (OSS)DRUG

Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g

Also known as: Suclear® solution (Phambio Korea, Seoul, Korea)
Oral sulfate solution (OSS) taking group
2L PEG/AscDRUG

Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g

Also known as: Haprep® powder (Phambio Korea, Seoul, Korea)
2L PEG/Asc taking group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Colonoscopy examinee aged 65-80
  • Examinee agree with informed consent

You may not qualify if:

  • Cognitive disorder, mental retardation
  • Bowel obstruction
  • Severe constipation (\<3 bowel movements per week with or without regular or intermittent laxatives)
  • History of bowel surgery
  • Liver cirrhosis or ascites
  • Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)
  • Inflammatory bowel disease
  • Pregnancy, lactating woman
  • Renal impairment or history of impaired renal function
  • History of hypersensitivity reaction to bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangwon National University Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

Study Officials

  • Sung Chul Park, MD, PhD

    KangWon National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single Blind (Investigator)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2017

First Posted

May 9, 2018

Study Start

November 2, 2017

Primary Completion

April 30, 2019

Study Completion

June 30, 2019

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

KR(1)