Post-Operative PainPhase 3NCT01539538
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
A Phase 3 study testing Sufentanil NanoTab PCA System/15 mcg and morphine IV PCA in people with Post-Operative Pain, run by Talphera, Inc at 16 sites in United States.
Trial summary
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after 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 NanoTab PCA System/15 mcg and morphine IV PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2012to Dec 2012
- 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 are 18 years or older
- Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
- Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.
Who cannot join
- 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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patients with an allergy or hypersensitivity to opioids
- Female patients who are pregnant or breast-feeding
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Florida Research Associates, LLC
DeLand, Florida, 32720
Eliza Coffee Memorial Hospital
Florence, Alabama, 35630
River City Clinical Research
Jacksonville, Florida, 32207
Drug Research and Analysis Corp
Montgomery, Alabama, 36106
Access Clinical Trials
Nashville, Tennessee, 37203
Lotus Clinical Research
Pasadena, California, 91105
Pensacola Research Consultants, Inc
Pensacola, Florida, 32504
Arizona Research Center
Phoenix, Arizona, 85023
Jean Brown Research
Salt Lake City, Utah, 84124
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229
Thorton Hospital
San Diego, California, 92037
Gulfcoast Research Institute
Sarasota, Florida, 34232
Shoals Medical Trials, Inc
Sheffield, Alabama, 35660
Phoenix Clinical Research LLC
Tamarac, Florida, 33321
About this study
Official title: A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
- Conditions
- Post-Operative Pain
- Being tested
- Sufentanil NanoTab PCA System/15 mcg, morphine IV PCA
- Keywords
- Adult post-operative inpatients who, are expected to require parenteral, opioid analgesia for at least 48, hours after open abdominal surgery, or hip/knee replacement surgery
- 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 NanoTab PCA System/15 mcgDrug
Also called Zalviso™
15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
morphine IV PCADrug
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental | Not described Receives: Drug: Sufentanil NanoTab PCA System/15 mcg |
| morphine IV PCA | Active comparator | Not described Receives: Drug: morphine IV PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Satisfaction
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 357 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
- NCT01539538
- Sponsor's protocol ID
- IAP309
- Status last verified
- Sep 2015
- First submitted
- 22 Feb 2012
- Last updated
- 1 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 2014 Nov;14(8):679-88. doi: 10.1111/papr.12238. Epub 2014 Aug 25.
PubMed 25155134
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
- ClinicalTrials.gov ID
- NCT01539538
- Acronym / sponsor ID
- IAP309
- Conditions
- Post-Operative Pain
- Keywords
- Adult post-operative inpatients who, are expected to require parenteral, opioid analgesia for at least 48, hours after open abdominal surgery, or hip/knee replacement surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 27 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental | Drug: Sufentanil NanoTab PCA System/15 mcg |
| morphine IV PCA | Active comparator | Drug: morphine IV PCA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients who are 18 years or older
- Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
- Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.
Key exclusion criteria (3 listed)
- 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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patients with an allergy or hypersensitivity to opioids
- Female patients who are pregnant or breast-feeding
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 PCA System/15 mcgAlso: Zalviso™15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours | Drug | Sufentanil NanoTab PCA System/15 mcg |
| morphine IV PCA1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours | Drug | morphine IV PCA |
Primary outcome
Patient Global Satisfaction
Time frame: 48 hours
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25155134Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 2014 Nov;14(8):679-88. doi: 10.1111/papr.12238. Epub 2014 Aug 25.
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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
16 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 NanoTab PCA System/15 mcg and morphine IV PCA in people with Post-Operative Pain, run by Talphera, Inc at 16 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 3 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 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 27 Mar 2014). 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?
Patient Global Satisfaction (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01539538, which also lists 1 linked publication.
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 1 Oct 2015.