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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AcelRx Pharmaceuticals, Inc.
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Sufentanil

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.