A Phase 2 interventional study of Morphine 6 mg and Fentanyl 100 µg in Acute Pain, sponsored by INSYS Therapeutics Inc. Withdrawn at 15 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-05.
Sponsored by INSYS Therapeutics Inc · Phase 2, Interventional, and Treatment
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.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
Browse Acute Pain studies →INSYS Therapeutics Inc is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg
Drug: Morphine 6 mg · Drug: Placebo Sublingual Spray
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 100 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 500 µg
Drug: Fentanyl 100 µg · Drug: Intravenous Placebo
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 200 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 1000 µg
Drug: Fentanyl 200 µg · Drug: Intravenous Placebo
Intravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg
Drug: Fentanyl 400 µg · Drug: Intravenous Placebo
Intravenous infusion - delivering morphine 6 mg
Also known as: IVM 6 mg, Standard of Care
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Also known as: FSS 100 µg, SUBSYS®
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Also known as: FSS 200 µg, SUBSYS®
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Also known as: FSS 400 µg, SUBSYS®
Matching sublingual spray - single unit delivering 0 µg fentanyl
Also known as: PSS
Matching intravenous infusion - delivering 0 mg morphine
Also known as: IVP
Percentage of participants requiring additional doses of randomized pain medication
Time frame: at 30 minutes after initial treatment
Percentage of participants requiring additional doses of randomized pain medication at secondary time points
Time frame: within 120 minutes after initial treatment
Visual analogue scale (VAS) Summed Pain Intensity Difference (SPID) calculated as Area under the Curve (AUC) every 30 minutes
Time frame: from baseline through 120 minutes after the initial dose of investigational product
Number of Investigational Product (IP) administrations
Time frame: within 120 minutes after initial treatment
Time to onset of pain relief (in minutes) using the stopwatch method
Time frame: within 120 minutes after first treatment
Richmond Agitation Sedation Scale (RASS) score
Time frame: within 120 minutes after first treatment
Percentage of Participants requiring rescue medication
Time frame: during the 5-day study period
Time until rescue medication was required
Time frame: during the 5-day study period
Percentage of participants experiencing a treatment-related adverse event
Time frame: during the 5-day study period
Percentage of participants with clinically significant changes in vital signs
Time frame: during the 5-day study period
This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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INSYS Therapeutics Inc