A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy

NCT ID: NCT00885274

Last Updated: 2015-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-08-31

Brief Summary

Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Split Dose

Doses of Pico-Salax split: one dose administered the night prior to colonoscopy and the other dose administered the day of the procedure.

Group Type: EXPERIMENTAL

Split Dose Pico-Salax

Intervention Type: DRUG

One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.

Traditional Dose

Both doses of Pico-Salax taken the evening prior to colonoscopy.

Group Type: ACTIVE_COMPARATOR

Pico-Salax

Intervention Type: DRUG

Both doses of Pico-Salax taken the evening prior to colonoscopy

Interventions

Pico-Salax

Both doses of Pico-Salax taken the evening prior to colonoscopy

Intervention Type: DRUG

Split Dose Pico-Salax

One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• colonoscopy indicated

Exclusion Criteria

• congestive heart failure
• ascites
• renal failure
• hyponatremia
• previous intestinal surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence Hookey

Assistant professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence Hookey, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

References

Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.

Reference Type: DERIVED

PMID: 22192423 (View on PubMed)

Other Identifiers

Hookey Pico-Salax Timing

Identifier Type: -

Identifier Source: org_study_id