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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00390598
Recruitment Status : Completed
First Posted : October 20, 2006
Last Update Posted : March 24, 2011
Information provided by:
Umeå University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: PEG (solution given 4 L) Drug: senna glycoside 36 mg and PEG (solution given 2 L) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: Laxabon (R) =PEG solution

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00390598

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Department of Surgery, Umeå University Hospital
Umeå, Sweden, SE 90185
Sponsors and Collaborators
Umeå University
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Study Chair: Peter Naredi, MD, PhD Umeå University
Principal Investigator: Markku M Haapamaki, MD, PhD Umeå University

Publications of Results:
Other Publications:
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Responsible Party: Markku Haapamäki, Umea University Identifier: NCT00390598     History of Changes
Other Study ID Numbers: TARE-05-073M
First Posted: October 20, 2006    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: December 2008

Keywords provided by Umeå University:
large bowel preparation
bowel cleansing
randomized controlled trial

Additional relevant MeSH terms:
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Sennoside A&B
Senna Extract
Pharmaceutical Solutions
Cardiac Glycosides
Gastrointestinal Agents
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs