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Trial record 24 of 56 for:    insys

Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain

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ClinicalTrials.gov Identifier: NCT02137525
Recruitment Status : Withdrawn (Study was never initiated)
First Posted : May 14, 2014
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Tracking Information
First Submitted Date  ICMJE May 12, 2014
First Posted Date  ICMJE May 14, 2014
Last Update Posted Date July 5, 2017
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date June 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
Percentage of participants requiring additional doses of randomized pain medication [ Time Frame: at 30 minutes after initial treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02137525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
Official Title  ICMJE A Randomized, Multicenter, Double-Blind, Double Dummy, Active Comparator, Dose-Ranging Study to Explore the Efficacy of SUBSYS® in Emergency Department Patients With Acute Pain
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE
  • Drug: Morphine 6 mg
    Intravenous infusion - delivering morphine 6 mg
    Other Names:
    • IVM 6 mg
    • Standard of Care
  • Drug: Fentanyl 100 µg
    Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
    Other Names:
    • FSS 100 µg
    • SUBSYS®
  • Drug: Fentanyl 200 µg
    Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
    Other Names:
    • FSS 200 µg
    • SUBSYS®
  • Drug: Fentanyl 400 µg
    Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
    Other Names:
    • FSS 400 µg
    • SUBSYS®
  • Drug: Placebo Sublingual Spray
    Matching sublingual spray - single unit delivering 0 µg fentanyl
    Other Name: PSS
  • Drug: Intravenous Placebo
    Matching intravenous infusion - delivering 0 mg morphine
    Other Name: IVP
Study Arms  ICMJE
  • Active Comparator: Morphine 6 mg
    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
    Interventions:
    • Drug: Morphine 6 mg
    • Drug: Placebo Sublingual Spray
  • Experimental: Fentanyl 100 µg
    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
    Interventions:
    • Drug: Fentanyl 100 µg
    • Drug: Intravenous Placebo
  • Experimental: Fentanyl 200 µg
    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
    Interventions:
    • Drug: Fentanyl 200 µg
    • Drug: Intravenous Placebo
  • Experimental: Fentanyl 400 µg
    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
    Interventions:
    • Drug: Fentanyl 400 µg
    • Drug: Intravenous Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 30, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2014)
176
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is able to understand the language in which the study is being conducted and has provided meaningful written informed consent for the study
  • Has an acute painful condition requiring parenteral analgesia as deemed necessary by the treating physician or physician extender
  • Has a pain score within protocol-specified parameters

Exclusion Criteria:

  • Has allergy to fentanyl or morphine
  • Has oxygen-dependent conditions or oxygen saturation <95%
  • Has planned or recent drug use outside protocol-specified parameters
  • Has any condition that, in the principal investigator's opinion, would place the patient at risk or influence the conduct of the study or interpretation of results
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02137525
Other Study ID Numbers  ICMJE INS-14-022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party INSYS Therapeutics Inc
Study Sponsor  ICMJE INSYS Therapeutics Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Giovanni DeCastro INSYS Therapeutics Inc
PRS Account INSYS Therapeutics Inc
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP