12 completed, 1 withdrawn. 7 Phase 3, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 7 |
| Phase 2 | 6 | Completed 5, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| Study of Indomethacin Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age Indomethacin Capsules low dose, Indomethacin Capsules high dose - Pain, Postoperative | Phase 2 | Completed | Iroko Pharmaceuticals, LLC | 30 | 2015-12-01 | 2018-01-26 |
| Study of Diclofenac Capsules to Treat Pain Following Surgery in Children Ages 6 to <17 Years of Age Diclofenac Capsules low dose, Diclofenac Capsules high dose - Pain, Postoperative | Phase 2 | Completed | Iroko Pharmaceuticals, LLC | 30 | 2015-05-01 | 2017-07-13 |
| Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain Meloxicam Test Capsules, Meloxicam Tablets - Osteoarthritis | Phase 2 | Withdrawn | Iroko Pharmaceuticals, LLC | 2015-05-01 | 2015-07-10 | |
| Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip Meloxicam Test Capsules - Osteoarthritis | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 600 | 2013-03-01 | 2015-05-12 |
| Study of Meloxicam Capsules to Treat Osteoarthritis Pain Meloxicam Test Capsules, Placebo Capsules - Osteoarthritis | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 403 | 2013-02-01 | 2015-03-11 |
| Study of Indomethacin Capsules to Treat Pain Following Bunionectomy Indomethacin, Placebo - Other Acute Postoperative Pain | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 373 | 2012-05-01 | 2014-03-17 |
| Study of Indomethacin Capsules to Treat Pain Following Bunionectomy Indomethacin, Celecoxib, Placebo - Other Acute Postoperative Pain | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 462 | 2012-02-01 | 2014-02-04 |
| Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain Diclofenac - Osteoarthritis | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 602 | 2012-01-01 | 2014-05-09 |
| Study of Diclofenac Capsules to Treat Pain Following Bunionectomy Diclofenac Test (lower dose), Diclofenac Test (upper dose), Celecoxib - Other Acute Postoperative Pain | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 428 | 2011-10-01 | 2014-02-04 |
| Study of Diclofenac Capsules to Treat Osteoarthritis Pain Diclofenac, Placebo - Osteoarthritis | Phase 3 | Completed | Iroko Pharmaceuticals, LLC | 305 | 2011-10-01 | 2014-05-26 |
| Study of Naproxen Capsules to Treat Dental Pain Naproxen Test, Naprosyn, Placebo - Dental Pain | Phase 2 | Completed | Iroko Pharmaceuticals, LLC | 254 | 2010-10-01 | 2012-05-22 |
| Study of Diclofenac Capsules to Treat Dental Pain Diclofenac Test (lower dose), Diclofenac Test (upper dose), Celecoxib 400 mg - Dental Pain | Phase 2 | Completed | Iroko Pharmaceuticals, LLC | 202 | 2009-09-01 | 2012-05-22 |
| Phase 2 Study of Indomethacin Capsules to Treat Dental Pain Celecoxib 400 mg, Placebo, Indomethacin Test (lower dose) - Dental Pain | Phase 2 | Completed | Iroko Pharmaceuticals, LLC | 203 | 2009-08-01 | 2012-05-22 |
Osteoarthritis (5) · Toothache (3) · Pain, Postoperative (2)
Celecoxib (4) · Diclofenac (3) · Indomethacin (3) · Meloxicam (1) · Naproxen (1)
United States (12)
Kyle Patrick, DO (5) · Alan Kivitz, MD (3) · Brandon Essink, MD (3) · Curtis S Horn, MD (3) · David Bouda, MD (3) · Douglas R Schumacher, MD (3) · Eddie Armas, MD (3) · Gregory F Lakin, DO (3) · Haydn M Thomas, MD (3) · Ira Gottlieb, DPM (3) · James R Clark, MD (3) · Jeffry Jacqmein, MD (3) · John Champlin, MD (3) · Kashyap Patel, MD (3) · Larkin T Wadsworth, MD (3)
PMID 24127200, PMID 25050589, PMID 25913498, PMID 26503347, PMID 26995799