Drugs / HalfLytely
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | HALFLYTELY | — | 2004-05-10 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 42 trials | ||||||
| Phase 4 | NCT00278967 | Feb → Aug 2006 | — | Braintree Laboratories | Completed | No outcome recorded |
| Phase 4 | NCT00164177 | Oct → Dec 2004 | — | Braintree Laboratories | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT01547130 Comparator | May 2008 → Dec 2010 | colonic neoplasm | Arya, Vijaypal, M.D., P.C. | Completed | No outcome recorded |
| Phase 3 | NCT01073930 Comparator | May → Oct 2010 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01073943 Comparator | May → Oct 2010 | — | Ferring Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HalfLYTELY | “A Preliminary Evaluation Of The Efficacy Of HalfLYTELY® For Bowel Cleansing Before Virtual Colonoscopy (VC) and Conventional Colonoscopy (CC).” NCT00164177 ↗ |
| Known as | HCP | “we have compared the Shudh™ colon cleanse (SCC) with HalfLytely(®) colon prep (HCP) to evaluate the efficacy” PMID 23456498 ↗ Mar 2013 |
| Modality | Other / unclassified | “PEG based solution (HalfLytely)” NCT01547130 ↗ |
| Route | Oral | “subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes” NCT01073930 ↗ |