Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
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| ClinicalTrials.gov Identifier: NCT01427296 |
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Recruitment Status :
Completed
First Posted : September 1, 2011
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
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Sponsor:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colon Cleansing | Drug: Polyethylene glycol Drug: Oral sodium phosphate solution | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2154 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing |
| Actual Study Start Date : | September 16, 2011 |
| Actual Primary Completion Date : | March 11, 2014 |
| Actual Study Completion Date : | December 9, 2014 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: OsmoPrep Tablets |
Drug: Oral sodium phosphate solution
OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
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| Active Comparator: HalfLytely and Bisacodyl Tablet |
Drug: Polyethylene glycol
HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
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Primary Outcome Measures :
- Distribution of the Overall Colon-cleansing Scale in Each Treatment Group. [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427296
Locations
| United States, California | |
| San Carlos, California, United States | |
| United States, Connecticut | |
| Bristol, Connecticut, United States | |
| United States, Georgia | |
| Macon, Georgia, United States | |
| Suwanee, Georgia, United States | |
| United States, Maryland | |
| Hagerstown, Maryland, United States | |
| United States, Michigan | |
| Wyoming, Michigan, United States | |
| United States, Missouri | |
| Mexico, Missouri, United States | |
| United States, New Jersey | |
| Vineland, New Jersey, United States | |
| United States, New York | |
| Great Neck, New York, United States | |
| New York, New York, United States | |
| United States, North Carolina | |
| Fayetteville, North Carolina, United States | |
| High Point, North Carolina, United States | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| Mentor, Ohio, United States | |
| United States, Texas | |
| Plano, Texas, United States | |
| United States, Virginia | |
| Chesapeake, Virginia, United States | |
| United States, Washington | |
| Bellevue, Washington, United States | |
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
| Responsible Party: | Valeant Pharmaceuticals International, Inc. |
| ClinicalTrials.gov Identifier: | NCT01427296 History of Changes |
| Other Study ID Numbers: |
OSBP4011 |
| First Posted: | September 1, 2011 Key Record Dates |
| Results First Posted: | January 18, 2018 |
| Last Update Posted: | January 18, 2018 |
| Last Verified: | December 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Valeant Pharmaceuticals International, Inc.:
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Colon Cleansing Bowel Prep Colonoscopy |
Additional relevant MeSH terms:
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Bisacodyl Cathartics Gastrointestinal Agents Laxatives |