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Completed

NCT Number: NCT01919255

Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation

The purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dae Kyung Sohn

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing compliance

Picolight + Coolprep [Day-Prior] Picolight + Clicolon [Day-Prior] Picolight + Coolprep [Split-Dose] Picolight + Clicolon [Split-Dose]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20-65 years of age
  • Elective colonoscopy of outpatients(consent to the study)

Exclusion criteria

  • Active enteritis, enteric bleeding, obstruction
  • Pregnant or lactating women
  • Severe liver or renal insufficiency
  • Allergic to any preparation components
  • History of heart disease (ischemic heart disease, congestive heart failure, arrythmia)
  • History of colorectal surgery
  • History abdominal surgery within 6 month
  • Toxic colitis or megacolon
  • Nausea or vomiting
  • Status emergent abdominal surgery (ex. acute appendicitis)
  • Uncontrolled clinically significant pre-existing electrolyte disturbance
  • Dehydration
  • Phenylketonuria
  • Glucose-6-phosphate dehydrogenase deficiency
  • Ileus
  • Suspicious hyperphosphatemia
  • Acute phosphate nephropathy

Treatment and study plan

Picolight + Coolprep

Drug

Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose]

Other names: Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate)

Picolight + Clicolon

Drug

Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose]

Other names: Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Clicolon(Sodium phosphate)

Primary outcomes

  1. Bowel preparation quality

    Time frame: the day of colonoscopy

    Aronchick bowel preparation score;

    Excellent: small volume of clear liquid or greater than 95% of surface seen

    Good: large volume of clear liquid 5% to 25% of the surface but greater than 90% of surface seen

    Fair: some semi-solid stool that could be suctioned or washed away, but greater than 90% of surface seen

    Poor: semi-solid stool that could not be suctioned or washed away and less than 90% of surface seen

    Inadequate: re-preparation needed

    (* 'success' of bowel preparation is defined as Aronchick's 'Excellent' or 'Good'.)

Secondary outcomes

  1. Patient tolerance

    Time frame: the day of colonoscopy

    Patient's tolerance;

    1= "none"; 2= "mild"; 3= "bothersome"; 4= "distressing"; 5= "severely distressing"

Other outcomes

  1. Adenoma detection rate

    Time frame: The day of colonoscopy

    Adenoma detection rate (%)

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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