Clinical trial NCT02662764: Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Official title: A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate-to-severe Acute Pain
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 320
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: Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg

Detailed description: 320 adult postoperative in-patients, who met all study entry requirements, and were expected to require opioid analgesia for at least 24 hours, and up to 72 hours, after surgery were enrolled. Patients used the Zalviso™ (sufentanil sublingual tablet system) 15 mcg to self-administer a tablet of study drug as needed for pain. The System was evaluated for usability and functionality for up to 72 hours.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients who were 18 years of age or older.
2. Patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation.
3. Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
4. Female patients of childbearing potential must have been using an effective method of birth control at the time of screening visit and for 30 days following the end of the study period. Acceptable methods of birth control included oral or transdermal contraceptives, condom, spermicidal foam, intrauterine device (IUD), progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-child bearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for \> 1 year, was specified. Patients using hormonal forms of contraception were also willing to use a barrier method of contraception from screening through 30 days following the study period.
5. Post-surgical patients who had been admitted to the PACU, and were expected to have acute pain requiring opioids for 24 - 72 hours after surgery.

Exclusion Criteria:

1. Patients who had taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more 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 who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
3. Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
4. Patients with an allergy or hypersensitivity to opioids.
5. Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
6. Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
7. Patients who were receiving oxygen therapy at the time of screening.

Primary outcomes:
measure: Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System
timeFrame: Up to 72 hours
measure: Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
timeFrame: Up to 72 hours
measure: Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout
timeFrame: Up to 72 hours
measure: Percentage of Patients With Misplaced Tablet(s)
timeFrame: Up to 72 hours
measure: Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)
timeFrame: Up to 72 hours
measure: Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"
timeFrame: Up to 48 hours
measure: Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
timeFrame: Up to 48 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"
timeFrame: Up to 48 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
timeFrame: Up to 48 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"
timeFrame: Up to 48 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"
timeFrame: Up to 72 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"
timeFrame: Up to 24 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Rate the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"
timeFrame: Up to 48 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"
timeFrame: Up to 72 hours
measure: Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours
timeFrame: Up to 24 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor"
timeFrame: Up to 48 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"
timeFrame: Up to 48 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"
timeFrame: Up to 48 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"
timeFrame: Up to 48 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"
timeFrame: Up to 72 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"
timeFrame: Up to 72 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"
timeFrame: Up to 72 hours
measure: Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"
timeFrame: Up to 72 hours
measure: Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
timeFrame: Up to 24 hours
measure: Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia After the 24-hour Study Period and Prior to or During the 48 Hour Study Period
timeFrame: Up to 48 hours
measure: Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period
timeFrame: Up to 72 hours
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)
timeFrame: Up to 24 hours
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period
timeFrame: Up to 48 hours
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period
timeFrame: Up to 72 hours
measure: Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)
timeFrame: Up to 24 hours
measure: Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)
timeFrame: Up to 48 hours
measure: Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)
timeFrame: Up to 72 hours
measure: Pain Intensity (PI) at Each Evaluation Time Point
timeFrame: Up to 72 hours
measure: Pain Intensity Difference (PID) at Each Evaluation Time Point
timeFrame: Up to 72 hours
measure: Pain Relief (PR) at Each Evaluation Time Point
timeFrame: Up to 72 hours
measure: Patient Usability Questionnaire (PUQ)
timeFrame: Up to 72 hours
measure: Nurse Usability Questionnaire (NUQ)
timeFrame: Up to 72 hours
measure: Number of Study Drug Doses Used
timeFrame: Up to 72 hours
measure: Average Hourly Use of Study Drug
timeFrame: Up to 72 hours
measure: Average Inter-dosing Interval (in Minutes)
timeFrame: Up to 72 hours
measure: Total Amount of Supplemental Morphine (mg) Utilized
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: United States
facility: Eliza Coffee Memorial Hospital
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Trials
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Sarasota
country: United States
facility: Gulfcoast Research Associates
state: Florida
city: Vero Beach
country: United States
facility: G&G Research
state: Florida
city: Vero Beach
country: United States
facility: Orthopedic Center of Vero Beach
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Decatur
country: United States
facility: Southeastern Center for Clinical Trials
state: Georgia
city: Houston
country: United States
facility: Westside Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Talphera, Inc
name: Pamela Palmer, MD, PhD
role: STUDY_DIRECTOR
References: