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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR NULYTELY

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Clinical Trials for Nulytely

Trial ID Title Status Sponsor Phase Summary
NCT00164151 A Comparison of the Efficacy and Safety of HalfLytely Vs Visicol Prior To Colonoscopy. Completed Braintree Laboratories Phase 3 The objective of this study is to determine the efficacy and safety of HalfLytely as compared to Visicol as bowel preparations before colonoscopic examination.
NCT00164164 HalfLytely Bowel Prep System for Colonoscopy Completed Braintree Laboratories Phase 3 The purpose of the this study was to compare the safety and efficacy of HalfLytely (2L NULYTELY + 20mg bisacodyl) to NULYTELY for preparation prior to colonoscopy.
NCT00689026 Efficacy of Lubiprostone in Combination With Standard PEG Preparation Terminated Takeda Pharmaceuticals North America, Inc. N/A A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p<0.001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint. We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nulytely

Condition Name

Condition Name for Nulytely
Intervention Trials
Colonoscopy 3
Bowel Preparation for Colonoscopy 1
Bowel Preparation 1
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Condition MeSH

Condition MeSH for Nulytely
Intervention Trials
Diabetes Mellitus, Type 2 1
Diabetes Mellitus, Type 1 1
Diabetes Mellitus 1
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Clinical Trial Locations for Nulytely

Trials by Country

Trials by Country for Nulytely
Location Trials
United States 9
Mexico 1
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Trials by US State

Trials by US State for Nulytely
Location Trials
Illinois 2
Texas 2
New Hampshire 1
Indiana 1
Minnesota 1
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Clinical Trial Progress for Nulytely

Clinical Trial Phase

Clinical Trial Phase for Nulytely
Clinical Trial Phase Trials
Phase 4 2
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Nulytely
Clinical Trial Phase Trials
Completed 5
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Nulytely

Sponsor Name

Sponsor Name for Nulytely
Sponsor Trials
Gastroenterology Services, Ltd. 2
Braintree Laboratories 2
National Center for Research Resources (NCRR) 1
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Sponsor Type

Sponsor Type for Nulytely
Sponsor Trials
Other 5
Industry 5
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Chinese Patent Office
Federal Trade Commission
Fish and Richardson
Baxter
US Department of Justice
Mallinckrodt
Cerilliant

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