Moderate-to-severe Acute PainPhase 3NCT02447848
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
A Phase 3 study testing sufentanil sublingual 30 mcg tablet in people with Moderate-to-severe Acute Pain, run by Talphera, Inc at 3 sites in United States.
Trial summary
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-severe Acute Pain
- What is being tested?
- sufentanil sublingual 30 mcg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present to the ER with moderate-to-severe pain due to obvious trauma or injury evident on physical examination.
- Patients classified as American Society of Anesthesiologists (ASA) class I-III
- Patients who are willing and capable of understanding and cooperating with the requirements of the study.
- Patients able to understand and communicate in English.
- Patients who have provided written informed consent and signed the IRB approved consent form.
Who cannot join
- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patients who have used any illicit drugs of abuse, abused prescription medication or alcohol (4 or more drinks per day) within one year before the start of the study.
- Patients with an allergy or hypersensitivity to opioids.
- Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the dose of study drug.
- Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
- Female patients who are pregnant (positive pregnancy test) or breastfeeding.
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- Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
- Patients who present to the ER using supplemental oxygen.
- Patients who have participated in a clinical trial of an investigational drug or device within 30 days of enrollment.
- Patients who are active or reserve duty with the US military.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hermann Memorial Medical Center
Houston, Texas, 77024
Ben Taub General Hospital
Houston, Texas, 77030
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for the Treatment of Acute Pain in Patients in Emergency Room Setting
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.
Read the detailed description
The study is a multicenter, open-label trial, in patients 18 years and older, who present to the ER with moderate-to-severe acute pain due to obvious trauma or injury evident on physical examination.
Upon meeting all entrance criteria, patients will be administered up to four doses of sufentanil 30 mcg and remain in the study for 5 hours for safety and efficacy measurements.
Safety will be monitored via periodic measurement of vital signs and continuous monitoring of oxygen saturation, as well as assessment of adverse events (AEs) and the use of concomitant medications.
Efficacy will be assessed by patient reports of pain intensity (PI) and pain relief. A Six-Item Screener (SIS) will be administered before and 1 hour after study drug administration to measure cognitive impairment. The Patient Global Assessment (PGA) and the Healthcare Professional Global Assessment (HPGA) will assess global satisfaction with the method of pain control.
- Conditions
- Moderate-to-severe Acute Pain
- Being tested
- sufentanil sublingual 30 mcg tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanil sublingual 30 mcg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| sufentanil sublingual tablet 30 mcg | Experimental | Patients may be administered one tablet every 60 minutes as needed during the study period Receives: Drug: sufentanil sublingual 30 mcg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).
The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain).
The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug.
The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity [PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period.
The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.
Measured: One hour
Secondary outcomes (2)
TOTPAR1 (Time-weighted)
The total pain relief (TOTPAR) is the time-weighted sum of the pain relief scores over the first hour (15 minutes, 30 minutes, 45 minutes and 1-hour after the first dose of study drug is taken) of the study period.
The minimum score is 0.00 and the maximum score is 4.00. A higher score indicates greater pain relief.
Measured: 1-hour
PI at Each Evaluation Time Point
Pain intensity at each evaluation time point after the first dose of study drug up through 5 hours is evaluated using an 11-point NRS where 0 equals no pain and 10 equals worst possible pain. The score was obtained at Baseline, 15- , 30-, 45- minutes, 1-hour, and 2-hours after the first dose for all patients, and at hours 3, 4, and 5 for cohort 2 (patients 41-76). Scores ranged from 0 -10 for the first two hours, and 2 - 10 for hours three to five.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate-to-severe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Pamela P. Palmer, MD, PhD, Study director, Talphera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447848
- Sponsor's protocol ID
- SAP302
- Status last verified
- Jul 2017
- First submitted
- 15 May 2015
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for the Treatment of Acute Pain in Patients in Emergency Room Setting
- ClinicalTrials.gov ID
- NCT02447848
- Acronym / sponsor ID
- SAP302
- Conditions
- Moderate-to-severe Acute Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 19 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.
Detailed description
The study is a multicenter, open-label trial, in patients 18 years and older, who present to the ER with moderate-to-severe acute pain due to obvious trauma or injury evident on physical examination.
Upon meeting all entrance criteria, patients will be administered up to four doses of sufentanil 30 mcg and remain in the study for 5 hours for safety and efficacy measurements.
Safety will be monitored via periodic measurement of vital signs and continuous monitoring of oxygen saturation, as well as assessment of adverse events (AEs) and the use of concomitant medications.
Efficacy will be assessed by patient reports of pain intensity (PI) and pain relief. A Six-Item Screener (SIS) will be administered before and 1 hour after study drug administration to measure cognitive impairment. The Patient Global Assessment (PGA) and the Healthcare Professional Global Assessment (HPGA) will assess global satisfaction with the method of pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sufentanil sublingual tablet 30 mcg | Experimental | Drug: sufentanil sublingual 30 mcg tabletPatients may be administered one tablet every 60 minutes as needed during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who present to the ER with moderate-to-severe pain due to obvious trauma or injury evident on physical examination.
- Patients classified as American Society of Anesthesiologists (ASA) class I-III
- Patients who are willing and capable of understanding and cooperating with the requirements of the study.
- Patients able to understand and communicate in English.
- Patients who have provided written informed consent and signed the IRB approved consent form.
Key exclusion criteria (10 listed)
- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patients who have used any illicit drugs of abuse, abused prescription medication or alcohol (4 or more drinks per day) within one year before the start of the study.
- Patients with an allergy or hypersensitivity to opioids.
- Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the dose of study drug.
- Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
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 |
|---|---|---|
| sufentanil sublingual 30 mcg tablet | Drug | sufentanil sublingual tablet 30 mcg |
Primary outcome
Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).
Time frame: One hour
The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity [PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.
2 secondary outcomes
TOTPAR1 (Time-weighted)
Time frame: 1-hour
PI at Each Evaluation Time Point
Time frame: 5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pamela P. Palmer, MD, PhD study director
Talphera, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sufentanil sublingual 30 mcg tablet in people with Moderate-to-severe Acute Pain, run by Talphera, Inc at 3 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1). (time frame: One hour). 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 19 Oct 2017.