SedationPhase 2NCT00894699
A Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTab™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
A Phase 2 study testing Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) in people with Sedation and Anxiety, run by Talphera, Inc at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- What is being tested?
- Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient must have provided written informed consent to participate in the study.
- Male or female patient between 18 to 60 (inclusive) years of age.
- Patient is planning to undergo an elective outpatient abdominal liposuction procedure.
- Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
- Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 20 and 35, inclusively.
- Female patients of childbearing potential must be using an effective method of birth control at the time of the screening visit and for 30 days following the dosing of study medication. 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. Patients using hormonal forms of contraception must also be willing to use a barrier method of contraception from screening through 30 days following the dose of study medication.
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- Patient is willing to receive antibiotics as per the normal practice of the surgeon.
- Patient understands that preoperative analgesics or anxiolytics are not permitted.
- Patient is willing to avoid caffeine and alcohol use within 24 hours before the procedure.
- The patient must be willing and able to understand the study procedures and the use of pain and anxiety scales, and to communicate meaningfully with the study personnel.
- The patient must have a caregiver available to escort the patient home following the procedure.
Who cannot join
- Patient who is expected to require less than 400 cc or more than 700 cc of abdominal fat removal during the procedure.
- Patient has previously not responded to opioid analgesics for treatment of pain.
- Patient has previously not responded to benzodiazepines for treatment of anxiety.
- Patient is currently taking any opioid or has taken any opioid for more than 7 consecutive days of daily use within the past 3 months prior to the procedure.
- Patient is currently taking any benzodiazepine or has taken any benzodiazepine for more than 7 consecutive days within the past 3 months prior to the procedure.
- Patient is taking monoamine oxidase inhibitors (MAOIs), or have taken MAOIs within 14 days prior to enrolling in the study.
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- Patient has an allergy or hypersensitivity to opioids.
- Patient who is currently taking anti-inflammatory drugs, including steroids.
- Use of drugs which are P450 3A4 inducers or inhibitors within 30 days of dosing including alprazolam, chlorpheniramine, cimetidine, fluoxetine, haloperidol, ketoconazole, itraconazole, erythromycin, clarithromycin, sildenafil, simvastatin, St. John's Wort.
- Patient who is taking calcium channel blockers or beta blockers.
- Patient who will consume grapefruit, or products made with grapefruit, within 3 days of study medication dosing.
- Patient with a history of chronic obstructive pulmonary disease (COPD) or any other respiratory condition or active pulmonary disease.
- Patient currently has sleep apnea that has been documented by a sleep laboratory study.
- Patient is a woman who is pregnant or lactating.
- Patient has a history of an anxiety disorder.
- Patients with oral mucositis or stomatitis.
- Patient has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
- Patient used an investigational drug or device within 30 days of screening visit.
- Patient has undergone a liposuction procedure previously.
- Patient has a history of migraine or chronic headache.
- Patient who has a positive urine screen for drugs of abuse at screening or on the day of procedure.
- Patient who has a positive alcohol screen on the day of the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, Inc.
Pasadena, California, 91105
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTabs™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
The purpose of this study is to evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).
- Being tested
- Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03), Placebo NanoTab™
- Keywords
- procedural sedation
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)Drug
Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
Placebo NanoTab™Drug
Single dose of sublingual placebo NanoTab™
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ Receives: Drug: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) |
| 2 | Placebo comparator | single dose of sublingual Placebo NanoTab™ Receives: Drug: Placebo NanoTab™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)
The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.
Measured: 4 hour study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2009
- Study completionSep 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 SedationStudies 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
- 40 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
- NCT00894699
- Sponsor's protocol ID
- ARX-C-007
- Status last verified
- May 2014
- First submitted
- 5 May 2009
- Last updated
- 25 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Clinical Efficacy, Safety and Tolerability of ARX-F03 Sublingual Sufentanil/Triazolam NanoTabs™ in Patients Undergoing an Elective Abdominal Liposuction Procedure
- ClinicalTrials.gov ID
- NCT00894699
- Acronym / sponsor ID
- ARX-C-007
- Keywords
- procedural sedation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Talphera, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 25 Jun 2014
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 evaluate the safety and effectiveness of a study medication that contains a combination of a pain medication, sufentanil, and a sedative, triazolam. This drug is being designed to provide mild sedation as well as reduce anxiety and pain before and during a procedure (in this case elective abdominal liposuction).
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 |
|---|---|---|
| 1 | Active comparator | Drug: Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ |
| 2 | Placebo comparator | Drug: Placebo NanoTab™single dose of sublingual Placebo NanoTab™ |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patient must have provided written informed consent to participate in the study.
- Male or female patient between 18 to 60 (inclusive) years of age.
- Patient is planning to undergo an elective outpatient abdominal liposuction procedure.
- Patient must be classified as American Society of Anesthesiologists (ASA) class I - III.
- Patient must have Body Mass Index [BMI = weight (kg)/height (m2)] between 20 and 35, inclusively.
Key exclusion criteria (22 listed)
- Patient who is expected to require less than 400 cc or more than 700 cc of abdominal fat removal during the procedure.
- Patient has previously not responded to opioid analgesics for treatment of pain.
- Patient has previously not responded to benzodiazepines for treatment of anxiety.
- Patient is currently taking any opioid or has taken any opioid for more than 7 consecutive days of daily use within the past 3 months prior to the procedure.
- Patient is currently taking any benzodiazepine or has taken any benzodiazepine for more than 7 consecutive days within the past 3 months prior to the procedure.
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 |
|---|---|---|
| Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03)Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™ | Drug | 1 |
| Placebo NanoTab™Single dose of sublingual placebo NanoTab™ | Drug | 2 |
Primary outcome
Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4)
Time frame: 4 hour study period
The primary efficacy endpoint of the study is the sedation level as assessed by the 10-point RASS, where unarousable is graded as minus 5 (- 5) and combative is graded as plus 4 (+ 4). The RASS was assessed at 15 time points throughout the four hour study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sublingual Sufentanil/Triazolam NanoTab™ (ARX-F03) in people with Sedation and Anxiety, run by Talphera, Inc at 1 site 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 11 inclusion and 22 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 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 25 Jun 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?
Summed Richmond Agitation Sedation Score (RASS) Over the 4-hour Study Period (SRS-4) (time frame: 4 hour study period). 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 25 Jun 2014.