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

NCT00390598 | Completed Phase 2

• 1 other identifier: TARE-05-073M
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Keywords

colonoscopy; large bowel preparation; bowel cleansing; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

• 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.

Study Arms (2)

senna 36 mG + PEG 2L

ACTIVE COMPARATOR

Bowel preparation with senna tablets 36 mG and PEG 2L prior to colonoscopy.

Drug: senna glycoside 36 mg and PEG (solution given 2 L)

4 L PEG

ACTIVE COMPARATOR

Bowel preparation with 4 L PEG prior to colonoscopy.

Drug: PEG (solution given 4 L)

Interventions

PEG (solution given 4 L) DRUG

Also known as: Laxabon (R) =PEG solution

4 L PEG

senna glycoside 36 mg and PEG (solution given 2 L) DRUG

Also known as: Pursennid ExLax (R)= senna, Laxabon (R)= PEG solution

senna 36 mG + PEG 2L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Department of Surgery, Umeå University Hospital

Umeå, SE 90185, Sweden

Location

Related Publications (2)

• Hookey LC, Depew WT, Vanner SJ. Combined low volume polyethylene glycol solution plus stimulant laxatives versus standard volume polyethylene glycol solution: a prospective, randomized study of colon cleansing before colonoscopy. Can J Gastroenterol. 2006 Feb;20(2):101-5. doi: 10.1155/2006/621367.

  PMID: 16482236 BACKGROUND

• Haapamaki MM, Lindstrom M, Sandzen B. Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol. Surg Endosc. 2011 Mar;25(3):897-901. doi: 10.1007/s00464-010-1293-6. Epub 2010 Sep 2.

  PMID: 20812020 RESULT

MeSH Terms

Interventions

Sennosides

Intervention Hierarchy (Ancestors)

Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Peter Naredi, MD, PhD

  Umeå University

  STUDY CHAIR

• Markku M Haapamaki, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: September 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 24, 2011

Record last verified: 2008-12

Locations

SE (1)