19 completed, 1 terminated. 11 Phase 1, 5 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 11 |
| Phase 3 | 5 | Completed 5 |
| Phase 2 | 4 | Completed 3, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain Oxycodone extended-release - Moderate-to-severe Chronic Noncancer Pain | Phase 3 | Completed | Egalet Ltd | 281 | 2016-03-07 | 2018-03-05 |
| Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain Oxycodone extended-release, Placebo of oxycodone extended-release - Moderate-to-severe Chronic Low Back Pain | Phase 3 | Completed | Egalet Ltd | 549 | 2016-03-01 | 2018-03-05 |
| SPRIX in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures SPRIX(intranasal ketorolac tromethamine) - Pain | Phase 3 | Completed | Egalet Ltd | 45 | 2014-03-01 | 2017-03-17 |
| Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers Morphine sulphate - Pain | Phase 1 | Completed | Egalet Ltd | 24 | 2008-12-01 | 2016-09-14 |
| Single Dose Pharmacokinetics of Egalet® Hydrocodone hydrocodone, hydrocodone & acetaminophen combination - Pain | Phase 1 | Completed | Egalet Ltd | 28 | 2008-11-01 | 2016-08-29 |
| Single Dose Pharmacokinetics of Egalet® Oxycodone Oxycodone hydrochloride - Pain | Phase 1 | Completed | Egalet Ltd | 16 | 2008-09-01 | 2016-08-29 |
| Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis Ketorolac Tromethamine, Oxymetazoline Hydrochloride, Fluticasone Propionate - Allergic Rhinitis | Phase 1 | Completed | Egalet Ltd | 24 | 2007-12-01 | 2018-03-06 |
| A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients Morphine Sulphate - Pain, Cancer | Phase 2 | Completed | Egalet Ltd | 36 | 2007-08-01 | 2016-08-29 |
| Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine Ketorolac tromethamine, Placebo - Migraine | Phase 2 | Completed | Egalet Ltd | 173 | 2007-07-01 | 2016-09-30 |
| The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years Ketorolac Tromethamine - Postoperative Pain | Phase 1 | Completed | Egalet Ltd | 20 | 2007-06-01 | 2017-03-16 |
| A Study of Controlled-Release Carvedilol Compared to Immediate-Release Carvedilol in Patients With Primary Hypertension Carvedilol - Hypertension | Phase 2 | Terminated | Egalet Ltd | 14 | 2007-04-01 | 2016-08-29 |
| Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects Ketorolac tromethamine, Fluticasone Propionate - Healthy Subjects | Phase 1 | Completed | Egalet Ltd | 36 | 2007-02-01 | 2017-03-15 |
| Study to Assess the PK of Ketorolac Tromethamine Intranasal and to Assess the Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine Ketorolac tromethamine, Oxymetazoline hydrochloride - Assess Pharmacokinetics of Ketorolac Tromethamine Intranasal and Assess Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine | Phase 1 | Completed | Egalet Ltd | 21 | 2007-01-01 | 2017-02-09 |
| Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers Ketorolac tromethamine - Healthy Volunteers | Phase 1 | Completed | Egalet Ltd | 40 | 2006-12-01 | 2018-03-06 |
| Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers Ketorolac tromethamine - Healthy Volunteers | Phase 1 | Completed | Egalet Ltd | 15 | 2006-01-01 | 2017-03-16 |
| Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery Intranasal Ketorolac Tromethamine, Intranasal Placebo - Postoperative Pain | Phase 3 | Completed | Egalet Ltd | 321 | 2005-12-01 | 2017-02-08 |
| Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers Ketorolac Tromethamine, Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl), Ketorolac Tromethamine with 5% Lidocaine HCl - Healthy Volunteers | Phase 1 | Completed | Egalet Ltd | 16 | 2005-08-01 | 2017-03-16 |
| A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery Ketorolac tromethamine, Placebo - Pain, Dental Impaction | Phase 2 | Completed | Egalet Ltd | 80 | 2004-02-01 | 2017-02-09 |
| Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Ketorolac tromethamine, Placebo - Postoperative Pain | Phase 3 | Completed | Egalet Ltd | 300 | 2003-06-01 | 2017-02-08 |
| Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device Ketorolac tromethamine - Healthy Subjects | Phase 1 | Completed | Egalet Ltd | 13 | 2002-09-01 | 2017-02-08 |
Pain (6) · Pain, Postoperative (3) · Chronic Pain (1) · Hypertension (1) · Migraine Disorders (1) · Neoplasms (1) · Rhinitis, Allergic (1) · Tooth, Impacted (1)
Ketorolac Tromethamine (11) · Fluticasone (2) · Morphine (2) · Oxymetazoline (2) · Carvedilol (1) · Hydrocodone (1) · Lidocaine (1) · Oxycodone (1)
United Kingdom (6) · United States (5) · Canada (2) · New Zealand (2) · Poland (2) · Australia (1) · Denmark (1) · Germany (1) · Lithuania (1)
Cyril Clarke, BSc MB BS MFPM (4) · Lincoln Bynum, MD (4) · Christine Andersen, M.Sc. (2) · Christine Andersen, MSc Pharm (2) · Christine Andersen, M.Sc.Pharm (1) · Cyril Clarke, BSc, MB BS, MFPM (1) · L Rankin, MD (1) · Linda M. Mundy, MD, PhD (1) · Roger Whiting, Ph D (1)