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ColonoscopyPhase 4NCT03520361

Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People

A Phase 4 study testing Oral sulfate solution (OSS) and 2L PEG/Asc in people with Colonoscopy, run by KangWon National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Colonoscopy
What is being tested?
Oral sulfate solution (OSS) and 2L PEG/Asc
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
1 siteSouth Korea
Study dates
2 Nov 2017to 30 Jun 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 10Show fewer
  • Inflammatory bowel disease
  • Pregnancy, lactating woman
  • Renal impairment or history of impaired renal function
  • History of hypersensitivity reaction to bowel preparation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289

Other trials in South Korea

About this study

Official title: Comparative Evaluation of the Efficacy of Oral Sulfate Solution (OSS) and 2L Polyethylene Glycol (PEG) With Ascorbic Acid (Asc) for Bowel Preparation of Elderly People: A Multicenter Prospective Randomized Study

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).

Read the detailed description

This study is a multicenter, prospective, randomized parallel arm, investigator initiated trial.

The aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.

99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.

Conditions
Colonoscopy
Being tested
Oral sulfate solution (OSS), 2L PEG/Asc
Keywords
Colonoscopy, Bowel preparation, Oral sulfate solution, Polyethylene glycol, Ascorbic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral sulfate solution (OSS)Drug

    Also called Suclear® solution (Phambio Korea, Seoul, Korea)

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

  • 2L PEG/AscDrug

    Also called Haprep® powder (Phambio Korea, Seoul, Korea)

    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

Study groups in NCT03520361
Study groupRoleWhat they receive
Oral sulfate solution (OSS) taking groupExperimentalOn 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.
Receives: Drug: Oral sulfate solution (OSS)
2L PEG/Asc taking groupActive comparatorOn 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.
Receives: Drug: 2L PEG/Asc

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (21)

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

    The 10-point scale from 0 to 10

    Measured: 3 months

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

    The 5-grade scale: very easy, easy, moderate, hard, and very hard

    Measured: 3 months

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

    The 5-grade scale: very good, good, neutral, bad, and very bad

    Measured: 3 months

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

    using questionnaires: yes, no

    Measured: 3 months

  5. Rate of subjects with nausea

    using questionnaires: yes, no

    Measured: 3 months

  6. Rate of subjects with vomiting

    using questionnaires: yes, no

    Measured: 3 months

  7. Rate of subjects with abdominal pain

    using questionnaires: yes, no

    Measured: 3 months

  8. Rate of subjects with abdominal distention

    using questionnaires: yes, no

    Measured: 3 months

  9. Rate of subjects with thirst

    using questionnaires: yes, no

    Measured: 3 months

  10. Rate of subjects with dizziness

    using questionnaires: yes, no

    Measured: 3 months

  11. Rate of subjects with paresthesia

    using questionnaires: yes, no

    Measured: 3 months

  12. Sodium level in mmol/L

    change in electrolyte values before and after bowel preparation

    Measured: an average of 1 year

  13. Potassium level in mmol/L

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  14. Chloride level in mmol/L

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  15. Magnesium level in mg/dL

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  16. Phosphorus level in mg/dL

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  17. Calcium level in mg/dL

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  18. Blood urea nitrogen level in mg/dL

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  19. Creatinine level in mg/dL

    change in electrolyte values before and after bowel preparation

    Measured: 3 months

  20. Serum osmolarity in mmol/kg

    change in osmolarity values before and after bowel preparation

    Measured: 3 months

  21. Urine osmolarity in mmol/L

    change in osmolarity values before and after bowel preparation

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2018
  2. Study start2 Nov 2017
  3. Primary completion30 Apr 2019 (estimated)
  4. Study completion30 Jun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
198 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520361
Sponsor's protocol ID
2017-03-011
Status last verified
Jun 2018
First submitted
20 Aug 2017
Last updated
20 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral sulfate solution (OSS) and 2L PEG/Asc in people with Colonoscopy, run by KangWon National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03520361.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.

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