CLINICAL TRIALS PROFILE FOR SUBSYS
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All Clinical Trials for SUBSYS
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00538850 ↗ | Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain | Completed | National Cancer Institute (NCI) | Phase 3 | 2007-10-01 | This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods). |
| NCT00538850 ↗ | Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain | Completed | INSYS Therapeutics Inc | Phase 3 | 2007-10-01 | This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Patients are titrated to an effective-dose of fentanyl sublingual spray in the open-label titration period and then proceed to the double-blind randomized period where they randomly receive 7 treatments with fentanyl sublingual spray and 3 treatments with placebo. Patients are treated for up to a total of 6-7 weeks (including both the open-label titration and the double-blind randomized periods). |
| NCT02137525 ↗ | Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain | Withdrawn | INSYS Therapeutics Inc | Phase 2 | 1969-12-31 | This study will explore effectiveness of three doses of fentanyl sublingual spray against an active comparator in emergency department (ED) patients with acute pain. After screening, eligible participants will participate in a treatment period (up to 2 hours) and a post-treatment evaluation period (up to 4 hours or discharge from the ED). Open-label standard of care rescue medication for pain can be given at any time during the study period, based on clinical judgment of the treating physician. Adverse events will be collected for five days after initial enrollment. |
| NCT02138396 ↗ | Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions | Completed | INSYS Therapeutics Inc | N/A | 2014-01-01 | The objective of this study is to compare the rate of absorption and bioavailability of fentanyl sublingual spray 400 mcg to fentanyl citrate 100 mcg by intramuscular injection. |
| NCT02138409 ↗ | Fentanyl Sublingual Spray for the Treatment of Acute Procedure-related Pain in a Monitored Setting | Withdrawn | INSYS Therapeutics Inc | Phase 3 | 2017-12-30 | Participants will be selected from patients who have been scheduled at the site for treatment of chronic pain without sedation. They will receive either fentanyl sublingual spray or a matching placebo sublingual spray that delivers no medication. Participants may take pain killers at any time after the procedure for pain relief. They will be given a diary card, which they will take home. They will record the name of the medication taken, the time, and dosage. The study coordinator will call participants about 24 hours after the procedure to collect information from the diary card and follow up information about pain and side effects (adverse events) after they left the site. |
| NCT02241486 ↗ | Sublingual Fentanyl and Procedural Burn Pain | Terminated | Loyola University | Phase 3 | 2013-09-01 | The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for SUBSYS
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