Acute PainPhase 2NCT02137525
Study to Explore Effectiveness of Sublingual Fentanyl Spray in Emergency Department Patients With Acute Pain
A Phase 2 study testing Morphine 6 mg, Fentanyl 100 µg and Fentanyl 200 µg in people with Acute Pain, run by INSYS Therapeutics Inc at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Morphine 6 mg, Fentanyl 100 µg and Fentanyl 200 µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento 29 Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
University of Cincinnati
Cincinnati, Ohio, 45267
Henry Ford Hospital
Detroit, Michigan, 48021
Wayne State University School of Medicine
Detroit, Michigan, 48201
Duke University School of Medicine
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
Kansas University Medical Center
Kansas City, Kansas, 66160
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Vanderbilt University
Nashville, Tennessee, 37232
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Maricopa Medical Center
Phoenix, Arizona, 85008
Washington University
St Louis, Missouri, 63110
Stony Brook University HSC
Stony Brook, New York, 11794
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: 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
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.
- Conditions
- Acute Pain
- Being tested
- Morphine 6 mg, Fentanyl 100 µg, Fentanyl 200 µg, Fentanyl 400 µg, Placebo Sublingual Spray
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine 6 mgDrug
Also called IVM 6 mg, Standard of Care
Intravenous infusion - delivering morphine 6 mg
Fentanyl 100 µgDrug
Also called FSS 100 µg, SUBSYS®
Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
Fentanyl 200 µgDrug
Also called FSS 200 µg, SUBSYS®
Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
Fentanyl 400 µgDrug
Also called FSS 400 µg, SUBSYS®
Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
Placebo Sublingual SprayDrug
Also called PSS
Matching sublingual spray - single unit delivering 0 µg fentanyl
Intravenous PlaceboDrug
Also called IVP
Matching intravenous infusion - delivering 0 mg morphine
| Study group | Role | What they receive |
|---|---|---|
| Morphine 6 mg | Active comparator | 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 Receives: Drug: Morphine 6 mg; Drug: Placebo Sublingual Spray |
| Fentanyl 100 µg | Experimental | 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 Receives: Drug: Fentanyl 100 µg; Drug: Intravenous Placebo |
| Fentanyl 200 µg | Experimental | 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 Receives: Drug: Fentanyl 200 µg; Drug: Intravenous Placebo |
| Fentanyl 400 µg | Experimental | 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 Receives: Drug: Fentanyl 400 µg; Drug: Intravenous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants requiring additional doses of randomized pain medication
Measured: at 30 minutes after initial treatment
Secondary outcomes (9)
Percentage of participants requiring additional doses of randomized pain medication at secondary time points
Measured: 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
Measured: from baseline through 120 minutes after the initial dose of investigational product
Number of Investigational Product (IP) administrations
Measured: within 120 minutes after initial treatment
Time to onset of pain relief (in minutes) using the stopwatch method
Measured: within 120 minutes after first treatment
Richmond Agitation Sedation Scale (RASS) score
Measured: within 120 minutes after first treatment
Percentage of Participants requiring rescue medication
Measured: during the 5-day study period
Time until rescue medication was required
Measured: during the 5-day study period
Percentage of participants experiencing a treatment-related adverse event
Measured: during the 5-day study period
Percentage of participants with clinically significant changes in vital signs
Measured: during the 5-day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Primary completion29 Jun 2017
Why it stopped: Study was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- INSYS Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni DeCastro, Study director, INSYS Therapeutics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137525
- Sponsor's protocol ID
- INS-14-022
- Status last verified
- Jun 2017
- First submitted
- 12 May 2014
- Last updated
- 5 Jul 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02137525
- Acronym / sponsor ID
- INS-14-022
- Conditions
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- INSYS Therapeutics IncIndustry (pharma, biotech, devices)
- Primary completion
- 29 Jun 2017 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Morphine 6 mg | Active comparator | Drug: Morphine 6 mg, Drug: Placebo Sublingual SprayPlacebo Sublingual Spray (PSS) + Intravenous Morphine (IVM 6 mg), every 30 minutes for two hours as needed (or until rescue), maximum exposure morphine 30 mg |
| Fentanyl 100 µg | Experimental | Drug: Fentanyl 100 µg, Drug: Intravenous PlaceboIntravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 100 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 500 µg |
| Fentanyl 200 µg | Experimental | Drug: Fentanyl 200 µg, Drug: Intravenous PlaceboIntravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 200 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 1000 µg |
| Fentanyl 400 µg | Experimental | Drug: Fentanyl 400 µg, Drug: Intravenous PlaceboIntravenous Placebo (IVP) + Fentanyl Sublingual Spray (FSS 400 µg), every 30 minutes for two hours as needed (or until rescue), maximum exposure fentanyl 2000 µg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine 6 mgAlso: IVM 6 mg, Standard of CareIntravenous infusion - delivering morphine 6 mg | Drug | Morphine 6 mg |
| Fentanyl 100 µgAlso: FSS 100 µg, SUBSYS®Fentanyl sublingual spray - single unit delivering 100 µg fentanyl | Drug | Fentanyl 100 µg |
| Fentanyl 200 µgAlso: FSS 200 µg, SUBSYS®Fentanyl sublingual spray - single unit delivering 200 µg fentanyl | Drug | Fentanyl 200 µg |
| Fentanyl 400 µgAlso: FSS 400 µg, SUBSYS®Fentanyl sublingual spray - single unit delivering 400 µg fentanyl | Drug | Fentanyl 400 µg |
| Placebo Sublingual SprayAlso: PSSMatching sublingual spray - single unit delivering 0 µg fentanyl | Drug | Morphine 6 mg |
| Intravenous PlaceboAlso: IVPMatching intravenous infusion - delivering 0 mg morphine | Drug | Fentanyl 100 µg, Fentanyl 200 µg, Fentanyl 400 µg |
Primary outcome
Percentage of participants requiring additional doses of randomized pain medication
Time frame: at 30 minutes after initial treatment
9 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni DeCastro study director
INSYS Therapeutics Inc
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Morphine 6 mg, Fentanyl 100 µg and Fentanyl 200 µg in people with Acute Pain, run by INSYS Therapeutics Inc at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants requiring additional doses of randomized pain medication (time frame: at 30 minutes after initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2017.