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

August 6, 2018 updated by: AcelRx Pharmaceuticals, Inc.

A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Florence, Alabama, United States, 35630
        • Eliza Coffee Memorial Hospital
      • Sheffield, Alabama, United States, 35660
        • Shoals Medical Trials
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • Florida
      • Sarasota, Florida, United States, 34232
        • Gulfcoast Research Associates
      • Vero Beach, Florida, United States, 32960
        • Orthopedic Center of Vero Beach
      • Vero Beach, Florida, United States, 32960
        • G&G Research
      • Wellington, Florida, United States, 33414
        • Visions Clinical Research
    • Georgia
      • Decatur, Georgia, United States, 30333
        • Southeastern Center for Clinical Trials
    • Texas
      • Houston, Texas, United States, 77027
        • Westside Surgical Hospital
      • Houston, Texas, United States, 77089
        • Hermann Drive Surgical Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zalviso™ 15 mcg
Zalviso™(sufentanil sublingual tablet system) 15 mcg
Drug: Zalviso™ 15 mcg
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
Other Names:
  • Zalviso™ (sufentanil sublingual tablet system) 15 mcg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients With Misplaced Tablet(s)
Time Frame: Up to 72 hours
Up to 72 hours
Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
Time Frame: Up to 24 hours
Up to 24 hours
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)
Time Frame: Up to 72 hours
Up to 72 hours
Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap
Time Frame: Up to 72 hours
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"
Time Frame: Up to 24 hours
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"
Time Frame: Up to 48 hours
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"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
Time Frame: Up to 24 hours
Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours
Time Frame: Up to 24 hours
Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
Time Frame: Up to 24 hours
Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours
Time Frame: Up to 24 hours
Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"
Time Frame: Up to 72 hours
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"
Time Frame: Up to 24 hours
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"
Time Frame: Up to 48 hours
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"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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
Time Frame: Up to 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"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"
Time Frame: Up to 48 hours
Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"
Time Frame: Up to 72 hours
Up to 72 hours
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
Time Frame: Up to 24 hours
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
Time Frame: Up to 48 hours
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
Time Frame: Up to 72 hours
Up to 72 hours
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)
Time Frame: Up to 24 hours
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
Time Frame: Up to 48 hours
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
Time Frame: Up to 72 hours
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)
Time Frame: Up to 24 hours
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)
Time Frame: Up to 48 hours
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)
Time Frame: Up to 72 hours
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
Time Frame: Up to 72 hours
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
Time Frame: Up to 72 hours
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
Time Frame: Up to 72 hours
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)
Time Frame: Up to 72 hours
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)
Time Frame: Up to 72 hours
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
Time Frame: Up to 72 hours
Up to 72 hours
Average Hourly Use of Study Drug
Time Frame: Up to 72 hours
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)
Time Frame: Up to 72 hours
Up to 72 hours
Total Amount of Supplemental Morphine (mg) Utilized
Time Frame: Up to 72 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AcelRx Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pamela Palmer, MD, PhD, AcelRx Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IAP312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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