A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
This study has been completed.
Sponsor:
Brooke Army Medical Center
Information provided by (Responsible Party):
Joel Z. Stengel, Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00953017
First received: August 5, 2009
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colonoscopy |
Drug: Miralax (PEG 3350) Drug: Amitiza (Lubiprostone) Drug: Dulcolax (Bisacodyl) Drug: Golytely (polyethylene glycol) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
| Official Title: | A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy |
Resource links provided by NLM:
Further study details as provided by Brooke Army Medical Center:
Primary Outcome Measures:
- The Cleanliness of the Prep as Measured by the Ottawa Scale [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.
Secondary Outcome Measures:
- Patient Satisfaction With the Prep Measured by 5 Point Likert Scale [ Time Frame: measured at check in to colonoscopy ] [ Designated as safety issue: Yes ]patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)
- Procedure Time [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]total colonoscopy procedure time
- Polyps Detected [ Time Frame: measured at the time of colonoscopy ] [ Designated as safety issue: No ]Number of polyps
| Enrollment: | 425 |
| Study Start Date: | July 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Miralax plus Amitiza
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.
|
Drug: Amitiza (Lubiprostone)
Amitiza 24mcg gelcap
|
|
Active Comparator: Miralax plus Dulcolax
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.
|
Drug: Dulcolax (Bisacodyl)
Bisacodyl 5mg tab x2
|
|
Active Comparator: Miralax
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.
|
Drug: Miralax (PEG 3350)
Miralax 255gm bottle
|
|
Active Comparator: Golytely (polyethylene glycol)
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
|
Drug: Golytely (polyethylene glycol)
Golytely 1 gallon
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations More Information
No publications provided by Brooke Army Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joel Z. Stengel, Gastroenterology Fellow, Brooke Army Medical Center |
| ClinicalTrials.gov Identifier: | NCT00953017 History of Changes |
| Other Study ID Numbers: | C.2009.209 |
| Study First Received: | August 5, 2009 |
| Results First Received: | September 6, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Brooke Army Medical Center:
|
Efficacy of bowel cleansing Patient tolerability Amitiza Dulcolax |
Miralax Colonoscopy preparation Bowel preparation Screening colonoscopy |
Additional relevant MeSH terms:
|
Bisacodyl Cathartics Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013