PainPhase 3FAIRTOP IINCT01270659
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
A Phase 3 study testing Fentanyl and Oxycodone/acetaminophen in people with Pain, run by University of Oklahoma at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia" Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl and Oxycodone/acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
- only if Emergency Department provider approves
- a negative pregnancy test is required for participation for women of childbearing age
Who cannot join
- If treating provider determines intravenous analgesia is required
- allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
- if patient has already been administered an opioid analgesic for their current injury
- patients on chronic opioids therapy or a history of opioid abuse
- breastfeeding mothers
- patients who plan to drive home after their emergency department visit
- history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillcrest Medical Center Emergency Department
Tulsa, Oklahoma, 74104
About this study
Official title: Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"
Read the detailed description
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Fentora 100 mcg buccal tablet
Fentanyl buccal tablet 100 mcg once
FentanylDrug
Also called Fentora buccal tablet 200 mcg
Fentanyl buccal tablet 200 mcg once
Oxycodone/acetaminophenDrug
Also called Percocet 5/325
Oxycodone/acetaminophen 5/325 mg once
oxycodone/acetaminophenDrug
Also called Percocet 5/325
Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
| Study group | Role | What they receive |
|---|---|---|
| Low-FBT | Experimental | Subject will receive FBT and placebo at a low dose Receives: Drug: Fentanyl |
| High-FBT | Experimental | Subject will receive the high dose regimen of FBT and a high dose placebo Receives: Drug: Fentanyl |
| Low control | Active comparator | Subject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" Receives: Drug: Oxycodone/acetaminophen |
| High control | Active comparator | Subject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" Receives: Drug: oxycodone/acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).
Measured: 60 minutes
Secondary outcomes (2)
Nausea Level
Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.
Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).
At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132).
Measured: every 5 minutes for the first 60 minutes
Number of Participants Experiencing Any Adverse Events
Occurrence of any adverse event.
Measured: Full 2 hours of the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2014
- Study completionOct 2014
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 PainStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen H Thomas, MD MPH, Principal investigator, University of OklahomaAnnette O Arthur, PharmD, Study director, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270659
- Sponsor's protocol ID
- 1774
- Acronym
- FAIRTOP II
- Status last verified
- May 2017
- First submitted
- 4 Jan 2011
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
- ClinicalTrials.gov ID
- NCT01270659
- Acronym / sponsor ID
- FAIRTOP II / 1774
- Conditions
- Pain
- Keywords
- Fentanyl buccal tablet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"
Detailed description
The subjects/patients will be asked if they would desire a low dose or high dose pain medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-FBT | Experimental | Drug: FentanylSubject will receive FBT and placebo at a low dose |
| High-FBT | Experimental | Drug: FentanylSubject will receive the high dose regimen of FBT and a high dose placebo |
| Low control | Active comparator | Drug: Oxycodone/acetaminophenSubject will receive active oxycodone/APAP 5/325 mg and lansoprazole solutab for the fentanyl "placebo" |
| High control | Active comparator | Drug: oxycodone/acetaminophenSubject will receive the higher dose of the active comparator, #2 oxycodone/APAP 5/325mg, and lansoprazole solutab for the fentanyl "placebo" |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
- only if Emergency Department provider approves
- a negative pregnancy test is required for participation for women of childbearing age
Key exclusion criteria (7 listed)
- If treating provider determines intravenous analgesia is required
- allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
- if patient has already been administered an opioid analgesic for their current injury
- patients on chronic opioids therapy or a history of opioid abuse
- breastfeeding mothers
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 |
|---|---|---|
| FentanylAlso: Fentora 100 mcg buccal tabletFentanyl buccal tablet 100 mcg once | Drug | Low-FBT |
| FentanylAlso: Fentora buccal tablet 200 mcgFentanyl buccal tablet 200 mcg once | Drug | High-FBT |
| Oxycodone/acetaminophenAlso: Percocet 5/325Oxycodone/acetaminophen 5/325 mg once | Drug | Low control |
| oxycodone/acetaminophenAlso: Percocet 5/325Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time | Drug | High control |
Primary outcome
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
Time frame: 60 minutes
Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).
2 secondary outcomes
Nausea Level
Time frame: every 5 minutes for the first 60 minutes
Number of Participants Experiencing Any Adverse Events
Time frame: Full 2 hours of the study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
Stephen H Thomas, MD MPH principal investigator
University of Oklahoma
Annette O Arthur, PharmD study director
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl and Oxycodone/acetaminophen in people with Pain, run by University of Oklahoma 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 3 inclusion and 7 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 20 Jun 2017. 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. 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 20 Jun 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?
Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level) (time frame: 60 minutes). 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 20 Jun 2017.