Moderate-to-severe Acute PainPhase 3NCT02662764
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
A Phase 3 study testing Zalviso™ 15 mcg in people with Moderate-to-severe Acute Pain, run by Talphera, Inc at 11 sites in United States.
Trial summary
Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-severe Acute Pain
- What is being tested?
- Zalviso™ 15 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 Sep 2016to 5 May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Southeastern Center for Clinical Trials
Decatur, Georgia, 30333
Eliza Coffee Memorial Hospital
Florence, Alabama, 35630
Westside Surgical Hospital
Houston, Texas, 77027
Hermann Drive Surgical Hospital
Houston, Texas, 77089
Arizona Research Center
Phoenix, Arizona, 85023
Jean Brown Research
Salt Lake City, Utah, 84124
Gulfcoast Research Associates
Sarasota, Florida, 34232
Shoals Medical Trials
Sheffield, Alabama, 35660
G&G Research
Vero Beach, Florida, 32960
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960
Visions Clinical Research
Wellington, Florida, 33414
About this study
Official title: 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
Read the 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.
- Conditions
- Moderate-to-severe Acute Pain
- Being tested
- Zalviso™ 15 mcg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zalviso™ 15 mcgDrug
Also called Zalviso™ (sufentanil sublingual tablet system) 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
| Study group | Role | What they receive |
|---|---|---|
| Zalviso™ 15 mcg | Experimental | Zalviso™(sufentanil sublingual tablet system) 15 mcg Receives: Drug: Zalviso™ 15 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System
Measured: Up to 72 hours
Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
Measured: Up to 72 hours
Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout
Measured: Up to 72 hours
Percentage of Patients With Misplaced Tablet(s)
Measured: Up to 72 hours
Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
Measured: Up to 24 hours
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)
Measured: Up to 72 hours
Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing
Measured: Up to 72 hours
Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap
Measured: 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"
Measured: 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"
Measured: 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"
Measured: Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
Measured: Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours
Measured: Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
Measured: Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours
Measured: Up to 24 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
Measured: Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"
Measured: Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
Measured: Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"
Measured: Up to 48 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
Measured: Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"
Measured: Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
Measured: Up to 72 hours
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: Up to 72 hours
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours
Measured: 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
Measured: Up to 24 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours
Measured: Up to 24 hours
Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours
Measured: Up to 24 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor"
Measured: Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"
Measured: Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"
Measured: Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"
Measured: Up to 48 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"
Measured: Up to 72 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"
Measured: Up to 72 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"
Measured: Up to 72 hours
Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"
Measured: Up to 72 hours
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 72 hours
Number of Study Drug Doses Used
Measured: 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
Measured: Up to 72 hours
Average Inter-dosing Interval (in Minutes)
Measured: 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.
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start28 Sep 2016
- Primary completion14 Apr 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate-to-severe Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Palmer, MD, PhD, Study director, Talphera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662764
- Sponsor's protocol ID
- IAP312
- Status last verified
- Aug 2018
- First submitted
- 20 Jan 2016
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Trial to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
- ClinicalTrials.gov ID
- NCT02662764
- Acronym / sponsor ID
- IAP312
- Conditions
- Moderate-to-severe Acute Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 8 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zalviso™ 15 mcg | Experimental | Drug: Zalviso™ 15 mcgZalviso™(sufentanil sublingual tablet system) 15 mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zalviso™ 15 mcgAlso: Zalviso™ (sufentanil sublingual tablet system) 15 mcgZalviso™ (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 | Drug | Zalviso™ 15 mcg |
Primary outcome
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
Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
Time frame: 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
Percentage of Patients With Misplaced Tablet(s)
Time frame: Up to 72 hours
Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
Time frame: 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
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
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
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
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
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
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
Time frame: 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
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
Time frame: 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
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
Time frame: 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
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
Time frame: 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
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
Time frame: 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
Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
Time frame: 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
Time frame: 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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Number of Study Drug Doses Used
Time frame: 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
Average Inter-dosing Interval (in Minutes)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela Palmer, MD, PhD study director
Talphera, Inc
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zalviso™ 15 mcg in people with Moderate-to-severe Acute Pain, run by Talphera, Inc at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 56 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.