Pain, PostoperativePhase 2NCT00859313
An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement
A Phase 2 study testing Sufentanil NanoTab PCA System/15 mcg in people with Pain, Postoperative, run by Talphera, Inc at 3 sites in United States.
Trial summary
This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Sufentanil NanoTab PCA System/15 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Aug 2009
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients between 45 and 80 years of age.
- Patient is scheduled for an elective unilateral, unicondylar, bi- or tri-compartmental, cemented or uncemented knee replacement under general or spinal anesthesia that does not include use of an intrathecal opioid.
- Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
- Patient must have a Body Mass Index (BMI) between 18 and 39, inclusively.
- Female patients of childbearing potential must be using an effective method of birth control from the screening visit through the end of study. Acceptable methods of birth control include 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-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified in the patient's CRF.
- The patient must be willing and able to understand the study procedures and the use of pain scales, and to communicate meaningfully with the study personnel.
- The patient must have the manual dexterity to handle the Sufentnail NanoTab PCA System and be able to follow directions for its use.
- The patient must provide written informed consent and sign the Informed Consent approved by the Institutional Review Board (IRB).
Who cannot join
- Patient has previously undergone a knee replacement of the same knee.
- A passive range-of-motion (PRM) will be used before the 12-hour study period is complete.
- Patient has previously not responded to opioid analgesics for treatment of pain.
- Patient is currently taking or has taken an opioid for more than 30 consecutive days of daily use at a daily dose equivalent of greater than 15 mg morphine within the past three months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patient has an allergy or hypersensitivity to opioids.
- Patient is taking monoamine oxidase inhibitors (MAOIs), or has taken MAOIs within 14 days prior to enrolling in the study.
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- Patient currently has sleep apnea that has been documented by a sleep laboratory study.
- Patient has any screening laboratory test value outside the laboratory normal range which is considered clinically significant by the Investigator.
- Patient is a woman who is pregnant or lactating.
- Patient has psychiatric disease or encephalopathy severe enough to prevent patient from providing reliable study documentation.
- Patient, in the Investigator's judgment, does not have adequate ability to read and understand English.
- Patient has a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including fracture or active infection.
- Patient has clinically significant renal or liver impairment which could affect metabolism or clearance of sufentanil.
- Patient has a painful physical condition other than knee arthritis that, in the opinion of the Investigator, may confound post-operative pain assessments.
- Patient has a history of drug, prescription medicine, or alcohol abuse within the past 2 years or a positive drug screen test for cocaine, amphetamines, barbiturates, phencyclidine, or methadone at screening.
- Patient is receiving oxygen therapy at the time of screening.
- Patient participated in a clinical trial of an investigational drug or device within 30 days of screening visit or is scheduled to receive an investigational product other than the Sufentanil NanoTab PCA System while participating in this study.
- Patient has a respiratory rate that is less than 8 breaths per minute or greater than 24 breaths per minute.
- Patient has arterial oxygen saturation by pulse oximetry (SpO2) of less than 90% with supplemental oxygen.
- Patient is not able to answer questions and follow commands.
- Patient has vomiting that is not responsive to standard treatment.
- The surgical procedure from incision to closure lasted more than 3 hours.
- There have been any deviations from the surgical or anesthetic protocols as specified in Section 6.1.2.1.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
West Alabama Research, Inc
Birmingham, Alabama, 35209
Memorial Hermann/Memorial City Medical Center
Houston, Texas, 77024
Orthopedic Center of Vero Beach
Vero Beach, Florida, 32960
About this study
Official title: An Open-Label Functionality, Safety, and Efficacy Study of the NanoTab® Delivery System/ARX-F01 15 Mcg in Patients Undergoing Elective Unilateral Knee Replacement
This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery.
Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Sufentanil NanoTab PCA System/15 mcg
- 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
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental | Not described Receives: Drug: Sufentanil NanoTab PCA System/15 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Without Device Failure
Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.
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 posted11 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2009
- Study completionAug 2009
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 Pain, PostoperativeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Talphera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pamela P Palmer, MD PhD, Study director, Talphera, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859313
- Sponsor's protocol ID
- ARX-C-004
- Status last verified
- Feb 2012
- First submitted
- 9 Mar 2009
- Last updated
- 1 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Functionality, Safety, and Efficacy Study of the NanoTab® Delivery System/ARX-F01 15 Mcg in Patients Undergoing Elective Unilateral Knee Replacement
- ClinicalTrials.gov ID
- NCT00859313
- Acronym / sponsor ID
- ARX-C-004
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Posted 27 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to evaluate the functionality of a device (Sufentanil NanoTab® PCA System) that has been developed for use by patients to self-administer the ARX-F01 pain medication (Sufentanil NanoTab 15 mcg) for the treatment of post-operative pain after undergoing knee replacement surgery.
Another goal of this study is to assess the safety and effectiveness of this non-invasive, sublingual route of administration of ARX-F01 in decreasing the amount of pain that a patient experiences following knee replacement surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sufentanil NanoTab PCA System/15 mcg | Experimental | Drug: Sufentanil NanoTab PCA System/15 mcg |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients between 45 and 80 years of age.
- Patient is scheduled for an elective unilateral, unicondylar, bi- or tri-compartmental, cemented or uncemented knee replacement under general or spinal anesthesia that does not include use of an intrathecal opioid.
- Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
- Patient must have a Body Mass Index (BMI) between 18 and 39, inclusively.
- Female patients of childbearing potential must be using an effective method of birth control from the screening visit through the end of study. Acceptable methods of birth control include 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-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or postmenopausal for ≥1 year, must be specified in the patient's CRF.
Key exclusion criteria (23 listed)
- Patient has previously undergone a knee replacement of the same knee.
- A passive range-of-motion (PRM) will be used before the 12-hour study period is complete.
- Patient has previously not responded to opioid analgesics for treatment of pain.
- Patient is currently taking or has taken an opioid for more than 30 consecutive days of daily use at a daily dose equivalent of greater than 15 mg morphine within the past three months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
- Patient has an allergy or hypersensitivity to opioids.
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 mcg15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours | Drug | Sufentanil NanoTab PCA System/15 mcg |
Primary outcome
Percent of Patients Without Device Failure
Time frame: 12 hours
Percent of patients who completed the study without a device failure. A device failure is defined as the failure to dispense a NanoTab, dispensing more than one NanoTab, or dispensing a broken NanoTab. Device failures were monitored and reported by study staff.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
- 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 P Palmer, MD PhD study director
Talphera, Inc
3 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 PCA System/15 mcg in people with Pain, Postoperative, run by Talphera, Inc at 3 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 8 inclusion and 23 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 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 27 Feb 2012). 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?
Percent of Patients Without Device Failure (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 1 Mar 2012.