Drugs / NuLYTELY
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NULYTELY | — | 1991-04-22 | fda.gov ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT00164151 | Jun 2001 → May 2002 | — | Braintree Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT00164164 | Aug 1999 → Jun 2000 | — | Braintree Laboratories | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00425594 | Jan → May 2007 | — | Braintree Laboratories | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT01630096 Comparator | Jun 2012 → Jun 2014 | Clostridium difficile colitis | Ascension Health | Unknown | No outcome recorded |
| Phase 4 | NCT01063049 Comparator | Feb 2010 → Feb 2011 | — | Gastroenterology Services, Ltd. | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NuLYTELY | “A Comparison of the Efficacy and Safety of Two Bowel Preparations: HalfLytely® (2L NuLYTELY and 20 mg Bisacodyl), and Visicol™ Prior To Colonoscopy.” NCT00164151 ↗ |
| Known as | Go-Lytely | “Nu-Lytely or Go-Lytely (polyethylene glycol 3350), produced by Braintree Laboratories, Incorporated, will be administered to the study patients.” NCT01630096 ↗ |
| Known as | Trilyte | “Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.” NCT01063049 ↗ |
| Route | Oral | “Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.” NCT01063049 ↗ |