Clinical trial NCT02662556: A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
Official title: A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Moderate-to-severe Pain
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.

Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Detailed description: This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure.

Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients who are 40 years of age or older.
2. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
3. Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).

Exclusion Criteria:

1. 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 prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
2. Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication.
3. Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II.
4. Patients who have used any illicit drugs of abuse within five years before the start of the study.
5. Patients who have abused any prescription medication or alcohol within one year before the start of the study.
6. Patients with an allergy or hypersensitivity to opioids.
7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
8. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).

Primary outcomes:
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
timeFrame: 12-hours
Secondary outcomes:
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).
timeFrame: 1 hours
measure: Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"
timeFrame: 12 hours or at patients' termination from study
measure: Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"
timeFrame: 12 hours or until patients' termination from study
Other outcomes:
Locations:
city: Houston
country: United States
facility: HD Research
state: Texas
city: Houston
country: United States
facility: Research Concepts
state: Texas
Study officials:
affiliation: Talphera, Inc
name: Pamela P. Palmer, MD, PhD
role: STUDY_DIRECTOR
References: