PainPhase 1/2NCT01012999
A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
A Phase 1/2 study testing sufentanil in people with Pain and Opiate, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2011
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or older;
- isolated traumatic injury to upper or lower extremity;
- alert and oriented to name, date, place; patient has a numeric pain score of 5 or higher;
- speaks English as their primary language;
- female patients are on birth control, menopausal, or are sterile (hysterectomy, tubal ligation)
Who cannot join
- injury isolated to a finger or toe;
- previous nasal or sinus surgery; chronic nasal problem;
- acute nasal problem (ie epistaxis, upper respiratory infection, sinusitis);
- pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency;
- presence of other painful injuries; systolic Blood Pressure less than 100 mm Hg;
- patient seems or is confused or has a head injury; room air oxygenation less than 95%;
Show all 11Show fewer
- patient has chronic obstructive pulmonary disease, severe asthma, oxygen-dependent pulmonary disease;
- impaired hepatic or renal function (obtained clinically or by history);
- weight more than 230 lbs (100 kg);
- alcohol or drug intoxication (per patient admission or clinical assessment of physician);
- elderly (> 70 years)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
Official title: Pain Control and Patient Satisfaction: a Dosing Study to Determine a Safe and Effective Dose of Intra-nasal Sufentanil to Treat Emergency Department Patients With Moderate to Severe Pain Due to Extremity Trauma
The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.
- Being tested
- sufentanil
- Keywords
- acute pain, intranasal, sufentanil,, Acute pain control with an intranasal opiate
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sufentanilDrug
Also called Sufenta
Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period
| Study group | Role | What they receive |
|---|---|---|
| Intranasal sufentanil, pain relief | Experimental | Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period Receives: Drug: sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief at Thirty Minutes
Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).
Measured: 30 min post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Difficulty enrolling patients
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 UtahThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Stephen, MD, University of Utah
- Investigators
- Robert Stephen, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012999
- Sponsor's protocol ID
- 32225
- Status last verified
- Jun 2017
- First submitted
- 11 Nov 2009
- Last updated
- 22 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control and Patient Satisfaction: a Dosing Study to Determine a Safe and Effective Dose of Intra-nasal Sufentanil to Treat Emergency Department Patients With Moderate to Severe Pain Due to Extremity Trauma
- ClinicalTrials.gov ID
- NCT01012999
- Acronym / sponsor ID
- 32225
- Keywords
- acute pain, intranasal, sufentanil,, Acute pain control with an intranasal opiate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 22 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 purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal sufentanil, pain relief | Experimental | Drug: sufentanilIntranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or older;
- isolated traumatic injury to upper or lower extremity;
- alert and oriented to name, date, place; patient has a numeric pain score of 5 or higher;
- speaks English as their primary language;
- female patients are on birth control, menopausal, or are sterile (hysterectomy, tubal ligation)
Key exclusion criteria (11 listed)
- injury isolated to a finger or toe;
- previous nasal or sinus surgery; chronic nasal problem;
- acute nasal problem (ie epistaxis, upper respiratory infection, sinusitis);
- pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency;
- presence of other painful injuries; systolic Blood Pressure less than 100 mm Hg;
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 |
|---|---|---|
| sufentanilAlso: SufentaIntra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period | Drug | Intranasal sufentanil, pain relief |
Primary outcome
Pain Relief at Thirty Minutes
Time frame: 30 min post dose
Measured pain relief on a visual analog scale (0-10- ten being the worst pain and zero being no pain at all).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert Stephen, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sufentanil in people with Pain and Opiate, run by University of Utah 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 22 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?
Pain Relief at Thirty Minutes (time frame: 30 min post dose). 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 22 Jun 2017.