Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2014 by Valeant Pharmaceuticals International, Inc..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01427296
First received: August 30, 2011
Last updated: May 30, 2014
Last verified: May 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Colon Cleansing |
Drug: Polyethylene glycol Drug: Oral sodium phosphate solution |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Valeant Pharmaceuticals International, Inc.:
Primary Outcome Measures:
- The number of Acute Kidney Injury events relative to person-time on study [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427296
Please refer to this study by its ClinicalTrials.gov identifier: 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.
More Information
| Responsible Party: | Valeant Pharmaceuticals International, Inc. |
| ClinicalTrials.gov Identifier: | NCT01427296 History of Changes |
| Other Study ID Numbers: | OSBP4011 |
| Study First Received: | August 30, 2011 |
| Last Updated: | May 30, 2014 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Valeant Pharmaceuticals International, Inc.:
|
Colon Cleansing Bowel Prep Colonoscopy |
Additional relevant MeSH terms:
|
Bisacodyl Cathartics Gastrointestinal Agents Laxatives |
ClinicalTrials.gov processed this record on September 28, 2016