Postoperative PainPhase 2NCT01206608
Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
A Phase 2 study testing SKY0402 + bupivacaine HCl and Mid-dose SKY0402 + bupivacaine HCl in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SKY0402 + bupivacaine HCl and Mid-dose SKY0402 + bupivacaine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2008
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who met all of the following criteria were eligible for inclusion in the study:
- Women, 18-40 years of age at the Screening Visit.
- Postmenopausal, surgically sterile, or willing to use an acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo primary, bilateral, sub-muscular, augmentation mammoplasty under general anesthesia.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- Able and willing to comply with all study visits and procedures.
- 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
- Subjects were not eligible for the study if they met any of the following criteria:
- Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
- Body weight less than 50 kilograms.
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or to opioid medication.
- Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational product, whichever was longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
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- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
- Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicated an increased vulnerability to study drugs and procedures, and exposed the subject to an unreasonable risk as a result of participating in this clinical trial (e.g., severe hepatic insufficiency, hypotension, heart block, or severely impaired cardiac function).
- In addition, the subject was ineligible to receive study drug if she met the following criterion during surgery:
- Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course.
Trial locations and contacts
1 site in 1 country.
United States1 site
Associates for Plastic Surgery
La Jolla, California, 92037
About this study
Official title: A Randomized, Double-Blind, Active-Control Study to Evaluate the Safety and Efficacy of a Single Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Augmentation Mammoplasty
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.
Read the detailed description
This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted to evaluate a single local administration of low dose or high dose of SKY0402 compared with 75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic, sub-muscular, augmentation mammoplasty under general anesthesia. Each subject was to serve as her own control.
A total of 40 subjects were randomized in a 1:1 ratio to receive one of the following regimens:
- Low-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.
- Mid-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.
Study drug was administered locally into the breast implant pocket at the end of surgery. After surgery, subjects were to receive standard treatment with acetaminophen 1000 mg three times daily and rescue analgesia with immediate-release oxycodone, as needed, for breakthrough pain.
Assessments of postoperative pain were conducted through 96 hours. Safety assessments were conducted including monitoring of local and systemic adverse events (AEs).
- Conditions
- Postoperative Pain
- Being tested
- SKY0402 + bupivacaine HCl, Mid-dose SKY0402 + bupivacaine HCl
- Keywords
- Breast augmentation, Pain, Analgesia
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY0402 + bupivacaine HClDrug
Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
Mid-dose SKY0402 + bupivacaine HClDrug
Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
| Study group | Role | What they receive |
|---|---|---|
| Low-dose SKY0402 + bupivacaine HCl | Active comparator | Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 Receives: Drug: SKY0402 + bupivacaine HCl |
| Mid-dose SKY0402 + bupivacaine HCl | Active comparator | Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 Receives: Drug: Mid-dose SKY0402 + bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores
Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.
Measured: Through 96 hours postdose
Secondary outcomes (1)
Number of Participants With Adverse Events
Adverse events were monitored through Day 8 and serious adverse events through Day 30.
Measured: Through 30 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionDec 2008
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 Postoperative PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kay Warnott, RN, ACNP, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206608
- Sponsor's protocol ID
- SKY0402-C-210
- Status last verified
- Feb 2021
- First submitted
- 19 Sep 2010
- Last updated
- 2 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Control Study to Evaluate the Safety and Efficacy of a Single Local Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Augmentation Mammoplasty
- ClinicalTrials.gov ID
- NCT01206608
- Acronym / sponsor ID
- SKY0402-C-210
- Conditions
- Postoperative Pain
- Keywords
- Breast augmentation, Pain, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Posted 6 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.
Detailed description
This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted to evaluate a single local administration of low dose or high dose of SKY0402 compared with 75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic, sub-muscular, augmentation mammoplasty under general anesthesia. Each subject was to serve as her own control.
A total of 40 subjects were randomized in a 1:1 ratio to receive one of the following regimens:
- Low-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.
- Mid-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.
Study drug was administered locally into the breast implant pocket at the end of surgery. After surgery, subjects were to receive standard treatment with acetaminophen 1000 mg three times daily and rescue analgesia with immediate-release oxycodone, as needed, for breakthrough pain.
Assessments of postoperative pain were conducted through 96 hours. Safety assessments were conducted including monitoring of local and systemic adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose SKY0402 + bupivacaine HCl | Active comparator | Drug: SKY0402 + bupivacaine HClMarcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 |
| Mid-dose SKY0402 + bupivacaine HCl | Active comparator | Drug: Mid-dose SKY0402 + bupivacaine HClMarcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women, 18-40 years of age at the Screening Visit.
- Postmenopausal, surgically sterile, or willing to use an acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo primary, bilateral, sub-muscular, augmentation mammoplasty under general anesthesia.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- Able and willing to comply with all study visits and procedures.
Key exclusion criteria (10 listed)
- Subjects were not eligible for the study if they met any of the following criteria:
- In addition, the subject was ineligible to receive study drug if she met the following criterion during surgery:
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 |
|---|---|---|
| SKY0402 + bupivacaine HClLow-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket | Drug | Low-dose SKY0402 + bupivacaine HCl |
| Mid-dose SKY0402 + bupivacaine HClMid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket | Drug | Mid-dose SKY0402 + bupivacaine HCl |
Primary outcome
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores
Time frame: Through 96 hours postdose
Assessments of postoperative pain were conducted through 96 hours and included pain intensity at rest (NRS-R) and with activity (NRS-A). The prescribed activity was to consist of raising the arm, in full extension at the elbow and wrist, to a position parallel with the axis of the torso. Pain intensity was scored on an 11-point scale, where 0 = no pain and 10 = worst possible pain.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Through 30 days postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- 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.
Kay Warnott, RN, ACNP 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 2 study testing SKY0402 + bupivacaine HCl and Mid-dose SKY0402 + bupivacaine HCl in people with Postoperative Pain, 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 8 inclusion and 10 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 2 Mar 2021. 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 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 6 Aug 2013). 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?
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) and With Activity (NRS-A) Pain Intensity Scores (time frame: Through 96 hours postdose). 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 2 Mar 2021.