A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Brooke Army Medical Center

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Drug: Miralax (PEG 3350); Drug: Golytely (polyethylene glycol); Drug: Amitiza (Lubiprostone); Drug: Dulcolax (Bisacodyl)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00953017

C.2009.209

Details and patient eligibility

About

Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Enrollment: 425 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion criteria

• elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
• previous diagnosis of congestive heart failure
• history of bowel obstruction
• history of solid organ transplant
• current pregnancy
• lactating mother
• participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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425 participants in 4 patient groups

Miralax plus Amitiza

Active Comparator group

Description:

106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.

Treatment:

Drug: Amitiza (Lubiprostone)

Miralax plus Dulcolax

Active Comparator group

Description:

107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.

Treatment:

Drug: Dulcolax (Bisacodyl)

Miralax

Active Comparator group

Description:

106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.

Treatment:

Drug: Miralax (PEG 3350)

Golytely (polyethylene glycol)

Active Comparator group

Description:

106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy

Treatment:

Drug: Golytely (polyethylene glycol)