A prospective, randomised study comparing a 3-sachet Picolax® treatment with the standard 2-sachet Picolax® for bowel cleansing prior to colonoscopy. - Picolax® 2- .v. 3-Sachet

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003735-23-GB

Enrollment

320

Registered

2008-07-15

Start date

2008-11-24

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Bowel preparation prior to elective complete colonoscopy. As 'bowel preparation' is not a specific medical condition, there is no MedDRA term.

Interventions

Trade Name: Picolax® Pharmaceutical Form: Oral solution INN or Proposed INN: SODIUM PICOSULFATE CAS Number: 10040456 Other descriptive name: MAGNESIUM OXIDE, LIGHT Other descriptive name: CITRIC ACID,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent - Patient referred for elective complete colonoscopy - = 18 years of age - Willing, able and competent to complete the entire procedure and to comply with study instructions - Females of childbearing potential must undergo a pregnancy test Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy - Hypersensitivity to any of the ingredients of the product - Congestive cardiac failure - Gastric retention - Active gastro-intestinal ulceration - Toxic colitis - Toxic megacolon - Ileus - Nausea and vomiting - Acute surgical abdominal conditions such as acute appendicitis - Known or suspected gastro-intestinal obstruction or perforation - Patients with severely reduced renal function - Participation in another clinical study in the last 30 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to demonstrate the superiority of a 3-sachet Picolax® treatment regimen over the standard 2-sachet Picolax®. Overall quality of the bowel preparation will be determined using the Ottawa Scale in 320 patients undergoing elective complete colonoscopy. ;Secondary Objective: - To evaluate safety (AEs, vital signs) - To compare patient acceptability and tolerability of both treatments - To investigate patient acceptability and tolerability of morning and afternoon procedures for each treatment - To evaluate cleansing in the individual colon segments - To evaluate overall cleansing scores between the two treatments - To evaluate the need for repeat procedures due to poor quality bowel preparation - To investigate the influence of dietary compliance and fluid intake on the quality of the bowel preparation. ;Primary end point(s): Proportion of examinations graded as a clinical success, based on endoscopist assessment of the quality of the bowel preparation in three colon segments using the Ottawa Scale. The three colon segments are: right (caecum and ascending colon), mid (transverse and descending colon) and rectosigmoid colon.	—

Measure

Time frame

Main Objective: The primary objective of this study is to demonstrate the superiority of a 3-sachet Picolax® treatment regimen over the standard 2-sachet Picolax®. Overall quality of the bowel preparation will be determined using the Ottawa Scale in 320 patients undergoing elective complete colonoscopy. ;Secondary Objective: - To evaluate safety (AEs, vital signs) - To compare patient acceptability and tolerability of both treatments - To investigate patient acceptability and tolerability of morning and afternoon procedures for each treatment - To evaluate cleansing in the individual colon segments - To evaluate overall cleansing scores between the two treatments - To evaluate the need for repeat procedures due to poor quality bowel preparation - To investigate the influence of dietary compliance and fluid intake on the quality of the bowel preparation. ;Primary end point(s): Proportion of examinations graded as a clinical success, based on endoscopist assessment of the quality of the bowel preparation in three colon segments using the Ottawa Scale. The three colon segments are: right (caecum and ascending colon), mid (transverse and descending colon) and rectosigmoid colon.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026