Post-Operative PainPhase 3NCT02356588
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
A Phase 3 study testing Sufentanil Tablet 30 mcg in people with Post-Operative Pain, run by Talphera, Inc at 4 sites in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Pain
- What is being tested?
- Sufentanil Tablet 30 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2015to Aug 2015
- 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
Inclusion Criteria (additional criteria not specified here):
- Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation:
- abdominoplasty
- open tension-free inguinal hernioplasty (Lichenstein repair with mesh)
- laparoscopic abdominal surgery
- Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
- Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit
- Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours.
Exclusion Criteria (additional criteria not specified here):
- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery
- Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
- Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
- Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Victory Medical Center
Houston, Texas, 77004
Research Concepts, LLC
Houston, Texas, 77024
Lotus Clinical Research
Pasadena, California, 91106
Shoals Medical Trials, Inc
Sheffield, Alabama, 35660
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
- Conditions
- Post-Operative Pain
- Being tested
- Sufentanil Tablet 30 mcg, Placebo Tablet
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil Tablet 30 mcgDrug
Also called ST 30 mcg
Placebo TabletDrug
Also called PT
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil Tablet 30 mcg | Experimental | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Receives: Drug: Sufentanil Tablet 30 mcg |
| Placebo Tablet | Placebo comparator | A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.
The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
Measured: 12 hours
Secondary outcomes (13)
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).
The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
Measured: 24 hours
TOTPAR12
Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.
Measured: 12 hours
TOTPAR24
Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.
Measured: 24 Hours
Time-weighted SPRID12
Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.
Measured: 12 hours
Time-weighted SPRID24
Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.
Measured: 24 hours
Patient Global Assessment
Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours
Measured: 24 hours
Healthcare Professional Global Assessment
Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours
Measured: 24 hours
Summed Pain Intensity Difference
The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.
The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
Measured: 1 hour
Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population
Measured: Cumulative through 12 hours
Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population
Measured: 24 hours
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Measured: Cumulative through 6 hours
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Measured: Cumulative through 12 hours
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Measured: Cumulative through 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionAug 2015
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 Post-Operative 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela Palmer, M.D., PhD, Study director, Talphera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356588
- Sponsor's protocol ID
- SAP301
- Status last verified
- Dec 2016
- First submitted
- 2 Feb 2015
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02356588
- Acronym / sponsor ID
- SAP301
- Conditions
- Post-Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Posted 13 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil Tablet 30 mcg | Experimental | Drug: Sufentanil Tablet 30 mcgA stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. |
| Placebo Tablet | Placebo comparator | Drug: Placebo TabletA stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Sufentanil Tablet 30 mcgAlso: ST 30 mcg | Drug | Sufentanil Tablet 30 mcg |
| Placebo TabletAlso: PT | Drug | Placebo Tablet |
Primary outcome
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
Time frame: 12 hours
The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
13 secondary outcomes
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).
Time frame: 24 hours
TOTPAR12
Time frame: 12 hours
TOTPAR24
Time frame: 24 Hours
Time-weighted SPRID12
Time frame: 12 hours
Time-weighted SPRID24
Time frame: 24 hours
Patient Global Assessment
Time frame: 24 hours
Healthcare Professional Global Assessment
Time frame: 24 hours
Summed Pain Intensity Difference
Time frame: 1 hour
Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population
Time frame: Cumulative through 12 hours
Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population
Time frame: 24 hours
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Time frame: Cumulative through 6 hours
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Time frame: Cumulative through 12 hours
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Time frame: Cumulative through 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, M.D., PhD study director
Talphera, Inc
4 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 Sufentanil Tablet 30 mcg in people with Post-Operative Pain, run by Talphera, Inc at 4 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?
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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 13 Feb 2017). 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?
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). (time frame: 12 hours). 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 13 Feb 2017.