Drugs / Hydrocodone ER
Hydrocodone ER
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02126917 | Nov → Dec 2009 | — | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02222740 | Sep → Dec 2002 | osteoarthritis | Zogenix, Inc. | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01922739 | Jul 2013 → Aug 2014 | — | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01240863 | Nov 2010 → Aug 2011 | chronic pain syndrome | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01223365 | Oct 2010 → Sep 2012 | chronic pain syndrome | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-02-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Acceptance for Review of NDA for its Investigational Twice-Daily Hydrocodone Bitartrate Extended-Release Tablets with Proprietary Abuse Deterrence Technology tevapharm.com ↗ |
| 2014-04-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Reports Positive Results from Pivotal Phase III Study to Evaluate Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Moderate to Severe Chronic Low Back Pain tevapharm.com ↗ |
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 | Hydrocodone ER | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01240863 ↗ |
| Known as | HC-ER | “Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules 50 mg” NCT02126917 ↗1“Hydrocodone Bitartrate Extended Release (HC-ER)” NCT02222740 ↗ |
| Known as | Hydrocodone Bitartrate Extended Release | “Hydrocodone Bitartrate Extended-Release (HC-ER) Capsules 50 mg” NCT02126917 ↗ |
| Route | Oral | “Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours.” NCT01223365 ↗ |