Phase 4
Completed N=2,092
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Colon Cleansing
Source: ClinicalTrials.gov NCT01427296 ↗
Enrolled (actual)
2,092
Serious AEs
1.9%
Results posted
Jan 2018
Primary outcomePrimary: Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. — 618; 243; 275; 423 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. |
618; 243; 275; 423; 116; 286 | — |
Eligibility Criteria
Inclusion Criteria
- Between 18 and 70 years of age, inclusive
- Scheduled for colonoscopy within 21 days of the screening visit
- Able to swallow tablets the size of a multivitamin without difficulty
Exclusion Criteria
- History of biopsy-proven acute phosphate nephropathy
- Known allergy or hypersensitivity to treatment arms
- History of gastric stapling or bypass procedure or history of gastric retention
- History of any other sodium phosphate preparation within 6 months prior to colonoscopy
Data sourced from ClinicalTrials.gov (NCT01427296). 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.