Clinical trial NCT02447848: Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate-to-severe Acute Pain
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2015-05-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).
timeFrame: One hour
Secondary outcomes:
measure: TOTPAR1 (Time-weighted)
timeFrame: 1-hour
measure: PI at Each Evaluation Time Point
timeFrame: 5 hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Houston
country: United States
facility: Hermann Memorial Medical Center
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Talphera, Inc
name: Pamela P. Palmer, MD, PhD
role: STUDY_DIRECTOR
References: