Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

NCT02662764 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IAP312
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 11

Brief Summary

Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg

Conditions

Moderate-to-severe Acute Pain

Outcome Measures

Primary Outcomes (56)

• Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System

  Up to 72 hours

• Percentage of Patients, if Any, With Tablets Dispensed But Not Requested

  Up to 72 hours

• Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout

  Up to 72 hours

• Percentage of Patients With Misplaced Tablet(s)

  Up to 72 hours

• Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)

  Up to 24 hours

• Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)

  Up to 72 hours

• Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing

  Up to 72 hours

• Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap

  Up to 72 hours

• Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"

  Up to 24 hours

• Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"

  Up to 48 hours

• Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"

  Up to 72 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours

  Up to 24 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours

  Up to 24 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours

  Up to 24 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours

  Up to 24 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"

  Up to 48 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"

  Up to 48 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"

  Up to 48 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"

  Up to 48 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"

  Up to 72 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"

  Up to 72 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"

  Up to 72 hours

• Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"

  Up to 72 hours

• 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"

  Up to 24 hours

• 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"

  Up to 48 hours

• 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"

  Up to 72 hours

• Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours

  Up to 24 hours

• Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours

  Up to 24 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours

  Up to 24 hours

• Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours

  Up to 24 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor"

  Up to 48 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"

  Up to 48 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"

  Up to 48 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"

  Up to 48 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"

  Up to 72 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"

  Up to 72 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"

  Up to 72 hours

• Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"

  Up to 72 hours

• Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period

  Up to 24 hours

• 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

  Up to 48 hours

• Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period

  Up to 72 hours

• Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)

  The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 24 hour period. The time-weighted SPID24 is the time-weighted summed PID over the 24-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from - 72 to 204.

  Up to 24 hours

• Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period

  The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points and throughout the 48 hour period. The time-weighted SPID48 is the time-weighted summed PID over the 48-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from -144 to 408.

  Up to 48 hours

• Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period

  The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 72 hour period. The time-weighted SPID72 is the time-weighted summed PID over the 72-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. The scores ranged from -239 to 624.

  Up to 72 hours

• Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)

  Total pain relief over the 24-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 96.00.

  Up to 24 hours

• Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)

  Total pain relief over the 48-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 192.00.

  Up to 48 hours

• Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)

  Total pain relief over the 72-hour study period. A higher TOTPAR means a greater relief in pain. Range of scores was from 0.00 to 288.00.

  Up to 72 hours

• Pain Intensity (PI) at Each Evaluation Time Point

  At protocol-specified time points, the patient is asked to self-record his/her current level of pain on an 11-point numerical rating scale where 0 equals no pain and 10 equals the worst possible pain.

  Up to 72 hours

• Pain Intensity Difference (PID) at Each Evaluation Time Point

  The PID at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The higher the PID score, the lower the pain intensity. The scores ranged from - 239 to 624.

  Up to 72 hours

• Pain Relief (PR) at Each Evaluation Time Point

  At protocol-specified time points, the patient is asked to self-record his/her current level of pain relief on 5-point numerical rating scale where 0 equaled no pain relief and 4 equaled complete pain relief. The baseline score references the baseline pain intensity score and the following timepoints reference pain relief scores.

  Up to 72 hours

• Patient Usability Questionnaire (PUQ)

  Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.

  Up to 72 hours

• Nurse Usability Questionnaire (NUQ)

  Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients

  Up to 72 hours

• Number of Study Drug Doses Used

  Up to 72 hours

• Average Hourly Use of Study Drug

  Average number of study drug doses used per hour, adjusting by treatment exposure time and study period

  Up to 72 hours

• Average Inter-dosing Interval (in Minutes)

  Up to 72 hours

• Total Amount of Supplemental Morphine (mg) Utilized

  Supplemental opioid medication (2 mg IV morphine) was allowed in the first 30 minutes after the first on-demand dose of study drug had been administered, if necessary, to keep a patient comfortable. Otherwise, supplemental opioid medication (2 mg IV morphine, no more frequently than hourly) was allowed for pain due to ambulation or with the initiation of passive range of motion therapy throughout the remainder of the study.

  Up to 72 hours

Study Arms (1)

Zalviso™ 15 mcg

EXPERIMENTAL

Zalviso™(sufentanil sublingual tablet system) 15 mcg

Drug: Zalviso™ 15 mcg

Interventions

Zalviso™ 15 mcg DRUG

Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours

Also known as: Zalviso™ (sufentanil sublingual tablet system) 15 mcg

Zalviso™ 15 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients who were 18 years of age or older.
• Patients who were scheduled to undergo surgery under general or spinal anesthesia that does not include intrathecal opioids during the operation.
• Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
• 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.
• 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.

You may not qualify if:

• 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).
• Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
• Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
• Patients with an allergy or hypersensitivity to opioids.
• Patients who were currently taking monoamine oxidase inhibitors (MAOIs) or had taken MAOIs within 14 days of the first dose of study drug.
• Patients with current sleep apnea that had been documented by a sleep laboratory study or were on home continuous positive airway pressure (CPAP).
• Patients who were receiving oxygen therapy at the time of screening.

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (11)

Eliza Coffee Memorial Hospital

Florence, Alabama, 35630, United States

Location

Shoals Medical Trials

Sheffield, Alabama, 35660, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Gulfcoast Research Associates

Sarasota, Florida, 34232, United States

Location

G&G Research

Vero Beach, Florida, 32960, United States

Location

Orthopedic Center of Vero Beach

Vero Beach, Florida, 32960, United States

Location

Visions Clinical Research

Wellington, Florida, 33414, United States

Location

Southeastern Center for Clinical Trials

Decatur, Georgia, 30333, United States

Location

Westside Surgical Hospital

Houston, Texas, 77027, United States

Location

Hermann Drive Surgical Hospital

Houston, Texas, 77089, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pamela Palmer, MD, PhD
• Organization: AcelRx Pharmaceuticals, Inc

ppalmer@acelrx.com

650-216-3504

Study Officials

• Pamela Palmer, MD, PhD

  Talphera, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 26, 2016
• Study Start: September 28, 2016
• Primary Completion: April 14, 2017
• Study Completion: May 5, 2017
• Last Updated: August 8, 2018
• Results First Posted: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)