Phase 3
Completed N=320
Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg
Moderate-to-severe Acute Pain
Source: ClinicalTrials.gov NCT02662764 ↗
Enrolled (actual)
320
Serious AEs
0.9%
Results posted
Aug 2018
Primary outcomePrimary: Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System — 2.2 percentage of patients
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Study to evaluate the overall performance of the Zalviso System™ (sufentanil sublingual tablet system) 15 mcg
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System |
2.2 | — |
| PRIMARY Percentage of Patients, if Any, With Tablets Dispensed But Not Requested |
— | — |
| PRIMARY Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout |
— | — |
| PRIMARY Percentage of Patients With Misplaced Tablet(s) |
3.8 | — |
| PRIMARY Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth) |
13 | — |
| PRIMARY Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure) |
5.6 | — |
| PRIMARY Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing |
— | — |
| PRIMARY Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap |
2.8 | — |
| PRIMARY Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent" |
86.1 | — |
| PRIMARY Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent" |
88.5 | — |
| PRIMARY Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent" |
100 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours |
1.4 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours |
12.6 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours |
40.8 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours |
45.2 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor" |
0.9 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair" |
10.6 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good" |
41.6 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent" |
46.9 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor" |
— | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair" |
— | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good" |
42.9 | — |
| PRIMARY Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent" |
57.1 | — |
| PRIMARY 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" |
91.1 | — |
| PRIMARY 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" |
95.1 | — |
| PRIMARY 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" |
100 | — |
| PRIMARY Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours |
0.7 | — |
| PRIMARY Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours |
8.1 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours |
38.9 | — |
| PRIMARY Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours |
52.2 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor" |
1.0 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair" |
3.9 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good" |
27.5 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent" |
67.6 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor" |
— | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair" |
— | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good" |
8.3 | — |
| PRIMARY Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent" |
91.7 | — |
| PRIMARY Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period |
2.5 | — |
| PRIMARY 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 |
2.8 | — |
| PRIMARY Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period |
— | — |
| PRIMARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24) |
63.09 | — |
| PRIMARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period |
130.69 | — |
| PRIMARY Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period |
204.66 | — |
| PRIMARY Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24) |
54.27 | — |
| PRIMARY Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48) |
111.42 | — |
| PRIMARY Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72) |
171.10 | — |
| PRIMARY Pain Intensity (PI) at Each Evaluation Time Point |
5.84; 4.77; 4.46; 4.05; 3.70; 3.37 | — |
| PRIMARY Pain Intensity Difference (PID) at Each Evaluation Time Point |
5.84; 1.07; 1.38; 1.79; 2.14; 2.48 | — |
| PRIMARY Pain Relief (PR) at Each Evaluation Time Point |
NA; 1.18; 1.42; 1.67; 1.81; 2.08 | — |
| PRIMARY Patient Usability Questionnaire (PUQ) |
90.5; 92.4; 82.3; 93.4; 86.1; 91.2 | — |
| PRIMARY Nurse Usability Questionnaire (NUQ) |
92.5; 92.5; 87.5; 100; 72.5; 90 | — |
| PRIMARY Number of Study Drug Doses Used |
15.7; 21.9; 22.8 | — |
| PRIMARY Average Hourly Use of Study Drug |
0.82 | — |
| PRIMARY Average Inter-dosing Interval (in Minutes) |
121.4; 123.2; 120.9 | — |
| PRIMARY Total Amount of Supplemental Morphine (mg) Utilized |
0.1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02662764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.