Phase 4
N=158
Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT00645801 ↗Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group — 1.38; 1.24 score on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lubiprostone (Amitiza) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endoscopist Evaluation of Colon Cleanliness in the Lubiprostone Group vs the Placebo Group |
1.38; 1.24 | 0.05 |
| SECONDARY Tolerability of the Colon Cleansing Group in the Lubiprostone Group vs the Placebo Group |
6; 4; 15; 14; 18; 25 | <0.05 sig |
| SECONDARY Change in Volume of PEG From Beginning of Bowel Prep to That at Completion of the Colonoscopy Preparation in the Two Groups |
0.79; 1.36 | <0.05 sig |
Summary
The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see the colon better during the colonoscopy to identify abnormal growths such as polyps or colon cancer.
Colonoscopy is considered the best way to screen for colon cancer screening because you can visualize the colon directly and remove or biopsy abnormal growths. The limiting step in the procedure is the quality of the colon preparation prior to the procedure. Many patients do not tolerate large volumes of liquid used to prepare the colon. The purpose of the study is to improve the quality of the prep by adding a pill laxative medication before starting the large volume laxative to better see the colon. The other aim of the study is to try to reduce the amount of of liquid laxative the patient has to drink by giving a pill laxative before starting the liquid laxative.
Eligibility Criteria
Inclusion Criteria
- Subject is at least 18 years old
- Subject is in good health
- Subject is undergoing a screening, surveillance or diagnostic colonoscopy
- Subject has a spontaneous bowel movement at least every 48 hours
Exclusion Criteria
- Subject has renal insufficiency demonstrated by serum creatinine > 1.4mg/dL
- Subject has Type 1 diabetes
- Subject has past or present diagnosis of Congestive Heart Failure
- Subject has past or present diagnosis of inflammatory bowel disease
- Subject had previous colon resection
- Subject has a preexisting electrolyte abnormality
- Subject has more than 3 spontaneous bowel movements daily
Data sourced from ClinicalTrials.gov (NCT00645801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.