Back to resultsStudy to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Primary Purpose
Moderate-to-severe Acute Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zalviso™ 15 mcg
Sponsored by
About this trial
This is an interventional treatment trial for Moderate-to-severe Acute Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Eliza Coffee Memorial Hospital
- Shoals Medical Trials
- Arizona Research Center
- Gulfcoast Research Associates
- G&G Research
- Orthopedic Center of Vero Beach
- Visions Clinical Research
- Southeastern Center for Clinical Trials
- Westside Surgical Hospital
- Hermann Drive Surgical Hospital
- Jean Brown Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Zalviso™ 15 mcg
Arm Description
Zalviso™(sufentanil sublingual tablet system) 15 mcg
Outcomes
Primary Outcome Measures
Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System
Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout
Percentage of Patients With Misplaced Tablet(s)
Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)
Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap
Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"
Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"
Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"
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"
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"
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"
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours
Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
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
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period
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.
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.
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.
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.
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.
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.
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.
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.
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.
Patient Usability Questionnaire (PUQ)
Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.
Nurse Usability Questionnaire (NUQ)
Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients
Number of Study Drug Doses Used
Average Hourly Use of Study Drug
Average number of study drug doses used per hour, adjusting by treatment exposure time and study period
Average Inter-dosing Interval (in Minutes)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02662764
First Posted
January 20, 2016
Last Updated
August 6, 2018
Sponsor
AcelRx Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02662764
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
May 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcelRx Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-severe Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zalviso™ 15 mcg
Arm Type
Experimental
Arm Description
Zalviso™(sufentanil sublingual tablet system) 15 mcg
Intervention Type
Drug
Intervention Name(s)
Zalviso™ 15 mcg
Other Intervention Name(s)
Zalviso™ (sufentanil sublingual tablet system) 15 mcg
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
Time Frame
Up to 72 hours
Title
Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout
Time Frame
Up to 72 hours
Title
Percentage of Patients With Misplaced Tablet(s)
Time Frame
Up to 72 hours
Title
Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
Time Frame
Up to 24 hours
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
Time Frame
Up to 24 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours
Time Frame
Up to 24 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
Time Frame
Up to 24 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours
Time Frame
Up to 24 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
Time Frame
Up to 48 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"
Time Frame
Up to 48 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
Time Frame
Up to 48 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"
Time Frame
Up to 48 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
Time Frame
Up to 72 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"
Time Frame
Up to 72 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
Time Frame
Up to 72 hours
Title
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"
Time Frame
Up to 72 hours
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
Time Frame
Up to 24 hours
Title
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
Title
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
Title
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)
Description
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.
Time Frame
Up to 24 hours
Title
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period
Description
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.
Time Frame
Up to 48 hours
Title
Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period
Description
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.
Time Frame
Up to 72 hours
Title
Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)
Description
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.
Time Frame
Up to 24 hours
Title
Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)
Description
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.
Time Frame
Up to 48 hours
Title
Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)
Description
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.
Time Frame
Up to 72 hours
Title
Pain Intensity (PI) at Each Evaluation Time Point
Description
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.
Time Frame
Up to 72 hours
Title
Pain Intensity Difference (PID) at Each Evaluation Time Point
Description
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.
Time Frame
Up to 72 hours
Title
Pain Relief (PR) at Each Evaluation Time Point
Description
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.
Time Frame
Up to 72 hours
Title
Patient Usability Questionnaire (PUQ)
Description
Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.
Time Frame
Up to 72 hours
Title
Nurse Usability Questionnaire (NUQ)
Description
Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients
Time Frame
Up to 72 hours
Title
Number of Study Drug Doses Used
Time Frame
Up to 72 hours
Title
Average Hourly Use of Study Drug
Description
Average number of study drug doses used per hour, adjusting by treatment exposure time and study period
Time Frame
Up to 72 hours
Title
Average Inter-dosing Interval (in Minutes)
Time Frame
Up to 72 hours
Title
Total Amount of Supplemental Morphine (mg) Utilized
Description
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.
Time Frame
Up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Palmer, MD, PhD
Organizational Affiliation
AcelRx Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Eliza Coffee Memorial Hospital
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Shoals Medical Trials
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Gulfcoast Research Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
G&G Research
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Orthopedic Center of Vero Beach
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Visions Clinical Research
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Southeastern Center for Clinical Trials
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States
Facility Name
Westside Surgical Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Hermann Drive Surgical Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
We'll reach out to this number within 24 hrs