Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

Completed · Phase 3

Conditions studied: Moderate-to-severe Acute Pain

In brief

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.

Key facts

Study ID

NCT02447848

Run by

Talphera, Inc

People needed

76

Starts

2015-10-01

Expected to finish

2016-07-01

Last updated by the study team

2017-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Hermann Memorial Medical Center — Houston, Texas, United States
• Ben Taub General Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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