19 completed, 1 terminated, 1 unknown. 7 Phase 4, 6 Phase 3, 5 Phase 2, 1 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 7 | Completed 6, Unknown 1 |
| Phase 3 | 6 | Completed 6 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 1 | 1 | Completed 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 |
|---|---|---|---|---|---|---|
| IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine Diclofenac postassium powder for oral solution and placebo injection, Ketorolac intramuscular injection and placebo oral solution - Migraine Headache | Phase 4 | Unknown | Scripps Health | 40 | 2016-01-01 | 2016-02-03 |
| Simulated Driving Performance, Daytime Sedation and Cognition in Healthy Volunteers Taking Gralise, Neurontin or Lyrica Gabapentin, Pregabalin, Placebo - Healthy | Phase 4 | Completed | Depomed | 32 | 2015-09-24 | 2020-06-01 |
| Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints Lazanda - Minor Procedural Pain | Phase 4 | Completed | Defense and Veterans Center for Integrative Pain Management | 23 | 2015-05-01 | 2016-10-25 |
| A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL, Placebo - Acute Pain | Phase 3 | Completed | Grünenthal GmbH | 216 | 2015-02-19 | 2020-01-18 |
| Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds Diclofenac Potassium for Oral Solution - Migraine | Phase 4 | Completed | Depomed | 25 | 2015-01-01 | 2017-07-25 |
| Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old Tapentadol - Moderate to Severe Acute Postoperative Pain | Phase 2 | Terminated | Grünenthal GmbH | 40 | 2014-11-05 | 2018-01-29 |
| Open Label Crossover Study Pharmacokinetics (PK) Study in Healthy Volunteers Receiving Various Forms of Fentanyl Fentanyl - Healthy | Phase 4 | Completed | Depomed | 13 | 2014-11-01 | 2018-03-16 |
| Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain diclofenac potassium oral solution - Pain | Phase 4 | Completed | Depomed | 51 | 2014-09-01 | 2017-07-11 |
| Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Zipsor® - Pain | Phase 4 | Completed | Depomed | 25 | 2013-11-01 | 2020-05-07 |
| Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea Fentanyl Pectin Nasal Spray, Placebo Nasal Spray, Walk Test - Advanced Cancers | Phase 2 | Completed | M.D. Anderson Cancer Center | 35 | 2013-06-11 | 2023-06-08 |
| Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures Fentanyl pectin - Other Acute Pain, Pain Experienced During Cystoscopy | Phase 1 | Completed | Richard C Reznichek, MD | 20 | 2013-02-01 | 2017-05-11 |
| Study of Gralise to Treat Fibromyalgia Patients Gabapentin ER - Fibromyalgia | Not applicable | Completed | The Center for Clinical Research, Winston-Salem, NC | 34 | 2012-07-01 | 2016-10-19 |
| Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations DM-1992, Sinemet IR - Parkinson's Disease, Motor Fluctuations | Phase 2 | Completed | Depomed | 34 | 2012-01-01 | 2014-03-10 |
| Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia Post Herpetic Neuralgia | Completed | Depomed | 201 | 2011-09-01 | 2013-03-21 | |
| Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women Gabapentin Extended Release, Placebo - Hot Flashes | Phase 3 | Completed | Depomed | 600 | 2010-08-01 | 2020-05-01 |
| Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women. Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg, Placebo - Hot Flashes | Phase 3 | Completed | Depomed | 565 | 2008-10-01 | 2012-02-22 |
| Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg, Placebo - Hot Flashes | Phase 3 | Completed | Depomed | 541 | 2008-09-01 | 2012-03-07 |
| Safety and Efficacy of Gabapentin in Postherpetic Neuralgia Gabapentin Extended Release tablets, Placebo - Neuralgia,Postherpetic | Phase 3 | Completed | Depomed | 452 | 2008-03-01 | 2012-02-22 |
| Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Gabapentin Extended Release tablets, Gabapentin - Hot Flashes | Phase 2 | Completed | Depomed | 108 | 2007-06-01 | 2011-06-08 |
| Safety and Efficacy of Gabapentin in Postherpetic Neuralgia Gabapentin extended-release tablets - Neuralgia, Postherpetic | Phase 3 | Completed | Depomed | 378 | 2006-05-01 | 2007-08-02 |
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Hot Flashes (4) · Acute Pain (3) · Neuralgia, Postherpetic (3) · Pain (3) · Herpes Zoster (2) · Lymphoma, Follicular (2) · Migraine Disorders (2) · Dyspnea (1) · Fibromyalgia (1) · Pain, Postoperative (1) · Parkinson Disease (1)
Gabapentin (5) · Diclofenac (4) · Fentanyl (3) · Solutions (2) · Sugars (2) · Tapentadol (2) · Ketorolac Tromethamine (1) · Pregabalin (1) · Surveys and Questionnaires (1)
United States (18) · Poland (2) · United Kingdom (2) · Argentina (1) · Bulgaria (1) · Croatia (1) · Czechia (1) · France (1) · Germany (1) · Hungary (1) · Russia (1) · Spain (1)
Rekha Sathyanarayana (4) · Bret Berner, Ph.D. (1) · David Hui, MD (1) · Emily Rubenstein Engel, MD (1) · James North, MD (1) · Michael W. Bartoszek, MD (1) · Richard Reznichek, MD (1)
PMID 27037091, PMID 19171730, PMID 20818838, PMID 22497967, PMID 22775354, PMID 24149930, PMID 27401508, PMID 29671676, PMID 31833000
2014 (1)