PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy (TARE-05-073M)

March 23, 2011 updated by: Umeå University

A Single Blind, Single Centre, Parallel Group, Randomized Controlled Trial Comparing PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy

The trial compares Laxabon® 4L versus Pursennid® Ex-Lax 36mg and 2L Laxabon® for large bowel cleansing prior to colonoscopy allocating patients planned for colonoscopy to one of the two cleansing regimens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Effective large bowel cleansing prior to colonoscopy is still not achieved in all cases that undergo the procedure. The use of balanced electrolyte-polyethylene glycol (PEG) solution have improved the cleansing results and shortened the time needed for preparing the bowel. The problem with using PEG solution alone is the relatively large volume of the solution that the patients need to drink. The recommendation is to drink the solution until diarrhea fluid is clear and often 4 L or more is needed. Many patients refuse to drink the sufficient volume needed to get a clean colon. The large volume load can be a risk to patients suffering from renal and/or heart insufficiency.

Good results of bowel cleansing have also been reported with sodium phosphate solution or tablets. The fluid volume needed to drink along with sodium phosphate is generally no problem but this regimen causes electrolyte disturbances that usually are subclinical and of no significance but in patients with renal or heart insufficiency the sodium phosphate is contraindicated due to the risk of serious electrolyte disturbances.

Several combinations of stimulant laxatives with PEG solution have been tested before and the actual combination has been compared in one randomized study(1). Low-volume PEG plus sennosides preparation was better tolerated but it was not as effective as standard large-volume PEG.

PEG solution (Laxabon®) 4L is used for large bowel cleansing in many centers in Sweden and is the standard regimen used in our colonoscopy unit. In this study we compare this standard regimen with senna glycoside (Pursennid® Ex-Lax) 36mg (tablets) taken orally in the night before the colonoscopy and 2L Laxabon® solution orally starting to drink the solution four hours prior to the colonoscopy.

The result of large bowel cleansing is evaluated during the colonoscopy according to two separate validated scoring methods (Aronchick and Ottawa scores). Abdominal symptoms, discomfort, subjective grading of how hard/easy it was to complete the cleansing program and extra costs are evaluated with questionnaires.

Study Type

Interventional

Enrollment

490

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, SE 90185
        • Department of Surgery, Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient scheduled to undergo elective complete colonoscopy as an outpatient
  • Age 18 or older
  • The patient gives written informed consent and can understand the information given
  • The patient can participate only once in the study

Exclusion Criteria:

  • Earlier resection of the large bowel or rectum
  • Active known colitis
  • Ileus or gastro-intestinal obstruction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: senna 36 mG + PEG 2L
Bowel preparation with senna tablets 36 mG and PEG 2L prior to colonoscopy.
Drug: senna glycoside 36 mg and PEG (solution given 2 L)
Other Names:
  • Pursennid ExLax (R)= senna
  • Laxabon (R)= PEG solution
Active Comparator: 4 L PEG
Bowel preparation with 4 L PEG prior to colonoscopy.
Drug: PEG (solution given 4 L)
Other Names:
  • Laxabon (R) =PEG solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of large bowel cleansing as assessed by the physician performing the colonoscopy. Two validated scoring systems are used.

Secondary Outcome Measures

Outcome Measure
The subjective grading of patients on ease of taking the large bowel preparation treatment.
Frequency of not completed large bowel preparation treatment.
Frequency of abdominal symptoms due to bowel preparation treatment.
Frequency of incomplete colonoscopies with insufficient view leading to a repeated colonoscopy due to low diagnostic quality at the first attempt.
Costs of large bowel cleansing.
Frequency of abdominal symptoms that start after onset of large bowel preparation treatment and that persists one week after the colonoscopy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Study Chair: Peter Naredi, MD, PhD, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 19, 2006

First Submitted That Met QC Criteria

October 19, 2006

First Posted (Estimate)

October 20, 2006

Study Record Updates

Last Update Posted (Estimate)

March 24, 2011

Last Update Submitted That Met QC Criteria

March 23, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARE-05-073M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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