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OpenTrials
Completed

NCT Number: NCT01509131

Evaluation of a Mixed Bowel Prep (2L PEG + Bisacodyl) Versus PEG With Ascorbate

It is hypothesized that PEG 2L with citrate and simeticone plus bisacodyl will have similar bowel cleansing efficacy versus PEG 2L with ascorbate. Safety, tolerability, acceptance and compliance of the two reduced volume PEG-based bowel preparation will be also compared.

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Key information

Conditions

Colonoscopy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Out-patients undergoing a complete colonoscopy
  • Patient written informed consent

Exclusion criteria

  • Pregnant or lactating women or at a risk of becoming pregnant
  • Hypersensitivity to any of the ingredients
  • History of anaphylaxis to drugs or allergic reactions in general
  • Known or suspected gastrointestinal obstruction or perforation
  • Toxic megacolon; major colonic resection
  • Heart failure (Class III or IV); severe renal failure; relevant diseases, that may interfere with the aim of the study
  • Phenylketonuria;Glucose-6-phosphate dehydrogenase deficiency
  • Unwillingness to co-operate and to comply with the requirements of the trial

Treatment and study plan

2L PEG-CS plus bisacodyl

Drug

Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)

Other names: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)

2L PEG-Asc

Drug

Patients will asked to take PEG-ASC according to labeling instructions

Other names: Moviprep

Primary outcomes

  1. Evaluation of the quality of bowel preparation by BBPS

    Time frame: 20 minutes

    BBPS is an established rating scale to evaluate the quality of bowel preparation. A score greater than 6 is considered as success. The rate of success will be compared between the two groups.

Secondary outcomes

  1. Difference in mucosal visibility between the two groups

    Time frame: 20 minutes

    Three point rating scale(0-2).

  2. Number of patients with adverse events

    Time frame: 24 hours

    Patient questioning.

  3. Difference in tolerability between the two groups

    Time frame: 24 hours

    Difference in the percentage of patients in the two groups who developed GI symptoms related to bowel preparation.

  4. Difference in patients acceptability between the two groups

    Time frame: 24 hours

    Difference in the percentage of patients in the two groups who were willing to repeat the preparation and easy to take the bowel preparation.

  5. Difference in patients compliance between the two groups

    Time frame: 24 hours

    Difference in the percentage of patients who took at least 75% of bowel preparation.

Sponsors and collaborators

Lead sponsor

Promefarm S.r.l.

Industry

Registry information

Official study title

Low Volume Bowel Preparation for Colonoscopy: a Comparison Between PEG-CS Plus Bisacodyl Versus PEG-ASC

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2012
Registry last updated
Jan 12, 2012

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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