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N/A Completed N=191 Randomized Double-blind Treatment

Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

Bowel Preparation for Colonoscopy
Source: ClinicalTrials.gov NCT00611442 ↗
Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: The Overall Cleanliness of the Prep as Measured by the Ottawa Scale — 4.8; 6.2 Ottawa Score

Summary

The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.

Outcome Measures

OutcomeResultp-value
PRIMARY
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
4.8; 6.2
SECONDARY
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
3.7; 3.2
SECONDARY
Procedure Time
17.8; 19.8
SECONDARY
The Number of Polyps Detected on Examination
48; 44

Eligibility Criteria

Inclusion Criteria

  • Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
  • Ages will be from 18 years of age and older

Exclusion Criteria

  • Chronic kidney disease
  • Previous diagnosis of congestive heart failure
  • History of bowel obstruction
  • History of solid organ transplant
  • Pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00611442). 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. Informational only — not medical advice.

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