13 completed, 1 unknown. 9 Phase 1, 3 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 8, Unknown 1 |
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 2 | Completed 2 |
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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 |
|---|---|---|---|---|---|---|
| Open-Label, Single-Dose Study to Evaluate the Safety and PK of DIC075V in Subjects With Renal Insufficiency and Hepatic Impairment Compared to Healthy Subjects and Evaluate the Safety and Pharmacokinetics of HPβCD When Administered in DIC075V Compared to Sporanox® in Healthy Subjects Sporanox, Diclofenac Sodium - Renal Insufficiency, Chronic, Hepatic Insufficiency | Phase 1 | Completed | Javelin Pharmaceuticals | 37 | 2008-12-01 | 2009-04-30 |
| Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine) PMI-150 (intranasal ketamine HCl); mometasone furoate - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 18 | 2007-11-01 | 2008-04-22 |
| Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers intravenous diclofenac sodium (DIC075V), ketorolac, oral diclofenac (Cataflam) - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 30 | 2007-10-01 | 2008-07-16 |
| Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium Intravenous diclofenac sodium (DIC075V) - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 89 | 2007-09-01 | 2009-02-12 |
| Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine intranasal ketamine - Pharmacokinetics | Phase 1 | Unknown | Javelin Pharmaceuticals | 48 | 2007-08-01 | 2008-02-29 |
| Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine intranasal ketamine - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 32 | 2007-07-01 | 2008-01-10 |
| Multiple Dose Pharmacokinetics of Intranasal Ketamine intranasal ketamine - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 18 | 2007-06-01 | 2008-01-10 |
| Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium Intravenous diclofenac sodium (DIC075V) 18.75 mg, Intravenous diclofenac sodium (DIC075V) 37.5 mg, Oral diclofenac potassium 50 mg - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 36 | 2007-03-01 | 2008-01-04 |
| Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of MNS075 (Intranasal Morphine) MNS075 - Healthy | Phase 1 | Completed | Javelin Pharmaceuticals | 32 | 2007-01-01 | 2008-01-14 |
| Efficacy and Safety of IV Diclofenac (DIC075V) for Pain After Abdominal or Pelvic Surgery Intravenous Diclofenac (DIC075V), Intravenous Ketorolac, placebo - Pain, Postoperative | Phase 3 | Completed | Javelin Pharmaceuticals | 331 | 2006-05-01 | 2009-05-22 |
| Efficacy and Safety of Intranasal Morphine for Pain After Elective Orthopedic Surgery Intranasal Morphine, Placebo, IV morphine - Pain, Postoperative | Phase 3 | Completed | Javelin Pharmaceuticals | 256 | 2006-05-01 | 2008-01-14 |
| Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg, Intranasal morphine (MNS075) 7.5 mg - Hallux Valgus | Phase 2 | Completed | Javelin Pharmaceuticals | 187 | 2005-01-01 | 2008-01-14 |
| Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction Intranasal Placebo, Intranasal Morphine 15 mg, Immediate Release Oral Morphine 60 mg - Post-Operative Pain, Third Molar Extraction | Phase 2 | Completed | Javelin Pharmaceuticals | 225 | 2001-09-01 | 2008-01-04 |
| Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain intranasal ketamine, placebo - Pain, Postoperative | Phase 2 | Completed | Javelin Pharmaceuticals | 40 | 2001-03-01 | 2008-02-07 |
Pain, Postoperative (5) · Agnosia (1) · Hallux Valgus (1) · Hammer Toe Syndrome (1) · Hepatic Insufficiency (1) · Renal Insufficiency, Chronic (1)
Diclofenac (3) · Aspirin (1) · Itraconazole (1) · Ketorolac (1) · Mometasone Furoate (1) · Morphine (1)
United States (10) · United Kingdom (1)
Kyle Christensen, DDS (2) · D. Ronald Goldwater, MD (1) · Douglas G Stoker, DPM (1) · Salvatore Febbraro, MD (1) · Suzanne Swann, MD (1) · Terri Lunsford, MD (1) · Thomas Marbury, MD (1) · William Gerson, D.O. (1) · William Smith, MD (1)