Acute PainPhase 2NCT01710345
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
A Phase 2 study testing Sufentanil NanoTab 20 mcg and Sufentanil NanoTab 30 mcg in people with Acute Pain, run by Talphera, Inc at 2 sites in United States.
Trial summary
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Sufentanil NanoTab 20 mcg and Sufentanil NanoTab 30 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2012to Feb 2013
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for bunion surgery
Who cannot join
- daily opioid use
- drug or alcohol abuse
- pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lotus Clinical Research
Pasadena, California
Jean Brown Research
Salt Lake City, Utah
About this study
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
- Conditions
- Acute Pain
- Being tested
- Sufentanil NanoTab 20 mcg, Sufentanil NanoTab 30 mcg, Placebo NanoTab
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil NanoTab 20 mcgDrug
Sufentanil NanoTab 30 mcgDrug
Placebo NanoTabDrug
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil NanoTab 20 mcg | Experimental | Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours Receives: Drug: Sufentanil NanoTab 20 mcg |
| Sufentanil NanoTab 30 mcg | Experimental | Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours Receives: Drug: Sufentanil NanoTab 30 mcg |
| Placebo NanoTab | Placebo comparator | Placebo NanoTab as needed every 60 minutes for 12 hours Receives: Drug: Placebo NanoTab |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID-12
The primary outcome measure is the summed pain intensity difference 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 SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710345
- Sponsor's protocol ID
- SAP202
- Status last verified
- Jan 2015
- First submitted
- 17 Oct 2012
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
- ClinicalTrials.gov ID
- NCT01710345
- Acronym / sponsor ID
- SAP202
- Conditions
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sufentanil NanoTab 20 mcg | Experimental | Drug: Sufentanil NanoTab 20 mcgSufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours |
| Sufentanil NanoTab 30 mcg | Experimental | Drug: Sufentanil NanoTab 30 mcgSufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours |
| Placebo NanoTab | Placebo comparator | Drug: Placebo NanoTabPlacebo NanoTab as needed every 60 minutes for 12 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for bunion surgery
Key exclusion criteria (3 listed)
- daily opioid use
- drug or alcohol abuse
- pregnant or breastfeeding women
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 NanoTab 20 mcg | Drug | Sufentanil NanoTab 20 mcg |
| Sufentanil NanoTab 30 mcg | Drug | Sufentanil NanoTab 30 mcg |
| Placebo NanoTab | Drug | Placebo NanoTab |
Primary outcome
SPID-12
Time frame: 12 hours
The primary outcome measure is the summed pain intensity difference 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 SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Pain
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sufentanil NanoTab 20 mcg and Sufentanil NanoTab 30 mcg in people with Acute Pain, run by Talphera, Inc at 2 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 1 inclusion and 3 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Jan 2015). 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?
SPID-12 (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 26 Jan 2015.