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A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy

A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00410215
Enrollment
315
Registered
2006-12-12
Start date
2006-02-28
Completion date
2008-01-31
Last updated
2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Brief summary

Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate the preparation. Pico-salax has recently been introduced in Canada as an alternative agent and is being used more and more widely despite an almost complete lack of clinical data supporting efficacy and safety. This study will establish the relative efficacy and patient tolerability of this agent and its safety profile. This is a very important, practical issue which continues to challenge gastroenterologists, surgeons, internists, family doctors and thousands of their patients in Canada on a daily basis. Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.

Detailed description

This is a randomized, investigator blinded clinical trial assessing the cleansing efficacy (using the Ottawa Bowel Preparation scale) and tolerance of three bowel cleansing regimens, two of which involve pico-salax.

Interventions

DRUGpicosalax plus bisacodyl

10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax

two sachets of picosalax taken orally the day prior to colonoscopy

two 45 ml bottles of sodium phosphate the day prior to colonoscopy

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Consecutive male and non-pregnant female patients * ≥ 18 years old * who require outpatient colonoscopy will be approached to consider participation in the study.

Exclusion criteria

* ileus or bowel obstruction; * previous colorectal surgery; * renal impairment; * pregnancy; * recent (\<6 months) myocardial infarction or unstable angina.

Design outcomes

Primary

MeasureTime frame
Ottawa Bowel Preparation scaleAt Colonoscopy.

Secondary

MeasureTime frame
Tolerance-Likert scale questionnaireAfter Preparation.
Safety Hemodynamics, Blood ChemistryAfter Preparation.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026