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)

This study has been completed.
Sponsor:
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT00390598
First received: October 19, 2006
Last updated: March 23, 2011
Last verified: December 2008
  Purpose

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 Intervention Phase
Colonoscopy
Drug: PEG (solution given 4 L)
Drug: senna glycoside 36 mg and PEG (solution given 2 L)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Umeå University:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 490
Study Start Date: September 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390598

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

Publications:
Responsible Party: Markku Haapamäki, Umea University
ClinicalTrials.gov Identifier: NCT00390598     History of Changes
Other Study ID Numbers: TARE-05-073M
Study First Received: October 19, 2006
Last Updated: March 23, 2011
Health Authority: Sweden: The National Board of Health and Welfare

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

Additional relevant MeSH terms:
Cardiac Glycosides
Senna Extract
Sennoside A&B
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 28, 2014