15 completed, 3 terminated, 2 recruiting, 2 withdrawn. 11 Not applicable, 5 Phase 4, 3 Phase 3, 2 Phase 2, 1 Phase 1.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 |
|---|---|---|---|---|---|---|
| Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer Metaxalone 640 mg, Metaxalone 800 MG - Healthy Participants | Phase 4 | Not yet recruiting | Primus Pharmaceuticals | 20 | 2026-09-15 | 2026-10-16 |
| Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis Diosmin, Placebo - Scleroderma, Systemic, Digital Ulcer | Not applicable | Recruiting | Primus Pharmaceuticals | 45 | 2025-05-02 | 2026-09-11 |
| Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg Metaxalone m640 mg oral tablet, Metaxalone 800 mg oral tablet - Healthy Participants | Phase 4 | Completed | Primus Pharmaceuticals | 20 | 2024-05-16 | 2025-08-07 |
| Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition metaxalone m640 mg, tizanidine 8mg - Cognitive Impairment | Phase 4 | Completed | Primus Pharmaceuticals | 20 | 2024-04-29 | 2026-09-11 |
| Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions. Metaxalone 640 mg Oral Tablet - Sciatica Acute, Lumbar Spinal Stenosis | Phase 4 | Recruiting | Primus Pharmaceuticals | 50 | 2023-11-15 | 2026-09-14 |
| EpiCeram for Skin Protection in Healthcare Workers EpiCeram - Irritant Contact Dermatitis | Not applicable | Terminated | Primus Pharmaceuticals | 1 | 2021-03-15 | 2024-08-28 |
| Vasculera in Participants With Lipedema Diosmiplex - Lipedema | Not applicable | Completed | Primus Pharmaceuticals | 34 | 2019-05-26 | 2024-12-12 |
| Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06 DFD06 - Psoriasis | Phase 2 | Terminated | Primus Pharmaceuticals | 22 | 2017-05-02 | 2024-03-07 |
| Efficacy of Vasculera in Prevention on Post-op Pain and Edema Following Lower Extremity Venous Treatment in the Outpatient Setting Vasculera, Placebo - Venous Insufficiency of Leg, Venous Reflux | Not applicable | Withdrawn | Corewell Health West | 2016-10-01 | 2022-11-23 | |
| Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon placebo, diosmiplex - Raynaud's Disease | Not applicable | Completed | Primus Pharmaceuticals | 87 | 2016-02-01 | 2017-08-17 |
| Patient Satisfaction Following Twice Daily Dosing With DFD-01 in Subjects With Moderate Plaque Psoriasis DFD-01 (betamethasone dipropionate) Spray, 0.05% - Plaque Psoriasis | Phase 4 | Completed | Primus Pharmaceuticals | 45 | 2016-02-01 | 2024-03-07 |
| DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis DFD01 Spray - Plaque Psoriasis | Phase 3 | Terminated | Primus Pharmaceuticals | 3 | 2015-08-19 | 2024-03-07 |
| Safety and Efficacy of Vasculera® in the Healing of Diabetic Skin Ulcers Vasculera - Diabetic Ulcers | Not applicable | Withdrawn | Primus Pharmaceuticals | 2015-02-01 | 2024-04-19 | |
| DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis DFD01 Spray, Comp01 Lotion - Plaque Psoriasis | Phase 2 | Completed | Primus Pharmaceuticals | 75 | 2014-01-01 | 2024-03-07 |
| A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis DFD01 Spray, Comp01 Lotion, Vehicle Lotion - Psoriasis | Phase 3 | Completed | Primus Pharmaceuticals | 394 | 2013-11-01 | 2024-03-07 |
| A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis DFD01 Spray, Vehicle Spray - Psoriasis | Phase 3 | Completed | Primus Pharmaceuticals | 277 | 2013-11-01 | 2024-03-07 |
| Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study. PD-L0101, placebo - Hyperlipidemia | Not applicable | Completed | Primus Pharmaceuticals | 103 | 2012-07-01 | 2016-01-26 |
| Efficacy of Flavocoxid 500 mg Compared With Naproxen 500 mg in Subjects With Moderate-severe Osteoarthritis of the Knee flavocoxid, Naproxen - Osteoarthritis of Knee | Not applicable | Completed | Primus Pharmaceuticals | 223 | 2008-01-01 | 2022-11-01 |
| Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee Naproxen, flavocoxid 250 mg, flavocoxid 500 mg - Osteoarthritis | Not applicable | Completed | Primus Pharmaceuticals | 350 | 2006-04-01 | 2015-10-21 |
| Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study flavocoxid, Naproxen - Osteoarthritis | Not applicable | Completed | Primus Pharmaceuticals | 60 | 2006-03-01 | 2015-10-21 |
Showing 20 of 23. Sign in to see all of them.
Osteoarthritis (4) · Psoriasis (3) · Bone Diseases, Metabolic (1) · Cognitive Dysfunction (1) · Dermatitis (1) · Dermatitis, Irritant (1) · Diabetes Mellitus, Type 2 (1) · Hyperlipidemias (1) · Lipedema (1) · Osteoarthritis, Knee (1) · Raynaud Disease (1) · Scleroderma, Diffuse (1) · Scleroderma, Systemic (1) · Sclerosis (1) · Spinal Stenosis (1)
flavocoxid (5) · Naproxen (4) · metaxalone (3) · Betamethasone (2) · Diosmin (2) · Tablets (2) · Clobetasol (1) · betamethasone-17,21-dipropionate (1) · tizanidine (1)
United States (19) · Canada (1)
Robert Levy, MD (3) · Joy Schechtman, DO (2) · Robert M Levy, MD (2) · Srinivas Sidgiddi, MD (2) · Alan J Kivitz, MD (1) · Alan Kivitz, MD (1) · Andrea Lawless, MD (1) · David A. McLain, MD (1) · David S Silver, MD (1) · Francesco Squadrito, MD (1) · J C Lukban, DO (1) · J Lukban, DO (1) · James Lukban, D.O. (1) · Jay Udani, MD (1) · Jennifer J. Watson, MD (1)
PMID 29657667, PMID 18796517, PMID 19555810, PMID 19857081, PMID 20357174
R41AR051232 (1)