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CompletedNCT01509131Updated Jan 12, 2012

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

A Phase 4 interventional study of 2L PEG-CS plus bisacodyl and 2L PEG-ASC in Colonoscopy, sponsored by Promefarm S.r.l.. Completed at 5 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-01-12.

Sponsored by Promefarm S.r.l. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
408
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Colonoscopy
03

In context

Lead sponsor

This is the only study on the registry with Promefarm S.r.l. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
408 participants (actual)

Study arms

  • Experimental
    2L PEG-CS plus bisacodyl

    Patients will be asked to take 2L PEG-CS plus bisacodyl (10-20 mg according to patient bowel habit)

    Drug: 2L PEG-CS plus bisacodyl

  • Active comparator
    2L PEG-ASC

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

    Drug: 2L PEG-ASC

Interventions

  • Drug2L PEG-CS plus bisacodyl

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

    Also known as: Lovolesse 2L plus Lovoldyl 5 mg (2-4 tablets)

  • Drug2L PEG-ASC

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

    Also known as: Moviprep

06

What researchers measure

Primary outcomes

  1. Evaluation of the quality of bowel preparation by BBPS

    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.

    Time frame: 20 minutes

Secondary outcomes

  1. Difference in mucosal visibility between the two groups

    Three point rating scale(0-2).

    Time frame: 20 minutes

  2. Number of patients with adverse events

    Patient questioning.

    Time frame: 24 hours

  3. Difference in tolerability between the two groups

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

    Time frame: 24 hours

  4. Difference in patients acceptability between the two groups

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

    Time frame: 24 hours

  5. Difference in patients compliance between the two groups

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

    Time frame: 24 hours

07

Study locations

5 sites
  • IRCCS Ospedale Casa Sollievo della Sofferenza
    San Giovanni Rotondo, Foggia 71013, Italy
  • IRCCS Humanitas
    Rozzano, Milano 20089, Italy
  • Spedali Civili
    Brescia, 25123, Italy
  • Azienda Ospedaliero Universitaria Careggi
    Firenze, 50134, Italy
  • Nuovo Regina Margherita
    Roma, 00185, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01509131
Lead sponsor
Promefarm S.r.l.
Responsible party
Sponsor
First posted
Jan 12, 2012
Start date
Mar 2010
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jan 12, 2012

Study contacts

Alessandro Repici, MD
principal investigator · IRCSS Istituto Clinico Humanitas, Rozzano (MI) - Italy
Renzo Cestari, Prof. MD
principal investigator · Spedali Civili di Brescia, Brescia - Italy
Cesare Hassan, MD
principal investigator · Nuovo Regina Margherita, Roma - Italy
Angelo Andriulli, MD
principal investigator · IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo - Italy
Vito Annese, MD
principal investigator · Ospedale Careggi, Firenze - Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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