Postoperative Pain ManagementPhase 1TTONCT00806806
Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
A Phase 1 study testing SKY0402 in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and extended pain relief that could greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize episodes of breakthrough pain. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- SKY0402
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects eligible for study entry will meet the following criteria:
- Male or female, ages at least 18 years and not over 55 years.
- Body mass index (BMI) within the range 20.0 to 30.0 kg/m2, inclusive.
- Applies to females only: Female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning > 30 days prior to the first dosing and continuing until > 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives.
- Good general health, evidenced by a lack of significantly abnormal findings on medical history and screening assessments.
- Pain intensity score of > 30 mm on a VAS after incision and application of an 18% acetic acid solution to nontreated skin (i.e., not infiltrated with any test or control article) at Screening.
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- Able and willing to comply with all study visits and procedures, including returning as scheduled for the second treatment visit.
- Able to speak, read, and understand the language of the ICF, study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments.
- Willing and capable of providing written informed consent.
Who cannot join
- A subject will not be eligible for the study if he or she meets any of the following criteria:
- A history of hypersensitivity to amide type local anesthetics.
- Pregnancy, nursing, or planning to become pregnant during the course of the study.
- Any current conditions that might interfere with pain assessments, including current pain.
- Conditions of the skin or neurological abnormalities that might alter pain sensitivity. These include excessive scarring, burns, skin grafts, and trauma. Tattoos are permitted.
- A history of keloid formation.
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- A coagulopathy or use of medications that might enhance bleeding.
- Use of any of the following medication within the times specified before study drug administration:
- Long-acting opioid mediations within 3 days.
- Any opioid medication within 24 hours.
- Any analgesic medication within 12 hours.
- Consumption of alcohol within 24 hours before either treatment visit.
- Any condition that, in the opinion of the Investigator, renders a subject unsuitable for participation in the study. NOTE: The specific reason(s) for exclusion will be documented in the Screening Log.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- Minor deviations in eligibility criteria are permitted if approved by the Pacira Medical Monitor in agreement with the Investigator prior to dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Medicine, Dept of Pharmacology
Columbus, Ohio, 43210-1239
About this study
Official title: A Phase 1 Randomized, Single-blind, Sequential Cohort, Crossover Study to Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and extended pain relief that could greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize episodes of breakthrough pain.
Read the detailed description
Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the time to onset will be recorded.
- Conditions
- Postoperative Pain Management
- Being tested
- SKY0402, Placebo
- Keywords
- pain management, postoperative
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY0402Drug
Local administration of SKY0402 followed by noxious stimulus
PlaceboDrug
Local administration of Placebo followed by noxious stimuli
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SKY0402 | Experimental | Not described Receives: Drug: SKY0402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to onset of action
Measured: 15 minutes
Secondary outcomes (1)
time to onset
Measured: bewteen 15 and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marius Ardeleanu, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806806
- Sponsor's protocol ID
- SKY0402C109
- Acronym
- TTO
- Status last verified
- Aug 2010
- First submitted
- 9 Dec 2008
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Apseloff G, Onel E, Patou G. Time to onset of analgesia following local infiltration of liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort, crossover study. Int J Clin Pharmacol Ther. 2013 May;51(5):367-73. doi: 10.5414/CP201775.
PubMed 23458225
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Single-blind, Sequential Cohort, Crossover Study to Evaluate the Onset of Action of SKY0402 Following Local Infiltration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00806806
- Acronym / sponsor ID
- TTO / SKY0402C109
- Conditions
- Postoperative Pain Management
- Keywords
- pain management, postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Given as a single perioperative injection, SKY0402 could provide adequate, continuous, and extended pain relief that could greatly simplify postoperative pain management, reduce the need for repeated administration, and minimize episodes of breakthrough pain.
Detailed description
Subjects will be given either SKY0402 or placebo in response to a noxious stimulus, and the time to onset will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| SKY0402 | Experimental | Drug: SKY0402 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female, ages at least 18 years and not over 55 years.
- Body mass index (BMI) within the range 20.0 to 30.0 kg/m2, inclusive.
- Applies to females only: Female subjects of childbearing potential with a nonsterilized male sexual partner must agree to use a hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device beginning > 30 days prior to the first dosing and continuing until > 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for > 1 year if they wish not to use contraceptives.
- Good general health, evidenced by a lack of significantly abnormal findings on medical history and screening assessments.
- Pain intensity score of > 30 mm on a VAS after incision and application of an 18% acetic acid solution to nontreated skin (i.e., not infiltrated with any test or control article) at Screening.
Key exclusion criteria (15 listed)
- A subject will not be eligible for the study if he or she meets any of the following criteria:
- A history of hypersensitivity to amide type local anesthetics.
- Pregnancy, nursing, or planning to become pregnant during the course of the study.
- Any current conditions that might interfere with pain assessments, including current pain.
- Conditions of the skin or neurological abnormalities that might alter pain sensitivity. These include excessive scarring, burns, skin grafts, and trauma. Tattoos are permitted.
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 |
|---|---|---|
| SKY0402Local administration of SKY0402 followed by noxious stimulus | Drug | SKY0402 |
| PlaceboLocal administration of Placebo followed by noxious stimuli | Drug | Placebo |
Primary outcome
time to onset of action
Time frame: 15 minutes
1 secondary outcome
time to onset
Time frame: bewteen 15 and 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2010.
- Derived from this study: PubMed 23458225Apseloff G, Onel E, Patou G. Time to onset of analgesia following local infiltration of liposome bupivacaine in healthy volunteers: a randomized, single-blind, sequential cohort, crossover study. Int J Clin Pharmacol Ther. 2013 May;51(5):367-73. doi: 10.5414/CP201775.
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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.
Marius Ardeleanu, MD study director
Pacira Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKY0402 in people with Postoperative Pain Management, run by Pacira Pharmaceuticals, 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 9 inclusion and 15 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 6 Sep 2010. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to onset of action (time frame: 15 minutes). 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 NCT00806806, 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 6 Sep 2010.