- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02447848
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
-
Texas
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Houston, Texas, United States, 77030
- Ben Taub General Hospital
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Houston, Texas, United States, 77024
- Hermann Memorial Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sufentanil sublingual tablet 30 mcg
Patients may be administered one tablet every 60 minutes as needed during the study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
One hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TOTPAR1 (Time-weighted)
Time Frame: 1-hour
|
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. |
1-hour
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PI at Each Evaluation Time Point
Time Frame: 5 hours
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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.
|
5 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Pamela P. Palmer, MD, PhD, AcelRx Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAP302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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