Postoperative PainPhase 2NCT01206595
Safety, Efficacy, and Pharmacokinetics of SKY0402 Administered as a Nerve Block in Subjects Undergoing Bunionectomy
A Phase 2 study testing SKY0402 and Bupivacaine HCl in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc.
Trial summary
The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- SKY0402 and Bupivacaine HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Dec 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were eligible for enrollment if they met the following criteria:
- Males and females ≥18 years of age at the Screening Visit. NOTE: Eligible females were postmenopausal or surgically sterile, or, if of child bearing potential, were not pregnant or nursing, and they agreed to not become pregnant during the study by using acceptable means of contraception for at least 1 month before and 1 month after dosing, including any of the following: hormonal contraceptives (oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device (IUD), lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair under general anesthesia, with or without internal fixation.
- NOTE: For the purpose of this protocol, all surgical procedures involving osteotomy of the first metatarsal (significant bone resection, excision, surgical fracture, etc.) or fusion of the first metatarsal phalangeal joint were considered qualified procedures, whether or not performed specifically to repair a bunion (hallus valgus deformity). Surgical techniques accompanied by minimal bone excision (e.g. cheilectomy) or procedures limited to soft tissue repair were not eligible for this study.
- American Society of Anesthesiology (ASA) Physical Class 1 or 2.
- Able and willing to comply with all study visits and procedures.
- Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales.
- Willing and capable of providing written informed consent.
Who cannot join
- Subjects were excluded from the study if they met any of the following criteria:
- Clinically significant electrocardiogram (ECG) abnormalities at Screening or on Day 1 (before dosing).
- Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might have increased the risk of surgery or complicated the subject's postoperative course.
- Opioid medication usage during the 7 day period preceding the administration of study drug.
- Current medical conditions that could have required treatment with analgesic medications in the postoperative period for pain that was not surgically related (e.g., rheumatoid arthritis).
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- Body mass index >30 kg/m^2.
- Body weight less than 60 kilograms.
- History of hypersensitivity or idiosyncratic reaction to amide type local anesthetic agents.
- History of hypersensitivity, idiosyncratic reactions, and other contraindications to the pain control agents (opioid or non-opioid) anticipated to be used postoperatively. These contraindications may have included the following: angioedema and bronchospastic reactivity to non-steroidal anti-inflammatory drug (NSAID), peptic ulcer (active within the last 3 months), or hepatic or renal insufficiency.
- Coagulation disorders or ongoing anticoagulation treatment.
- Administration of an investigational drug within 30 days or 5 half lives (of elimination), whichever was longer, prior to study drug administration.
- Suspected or known history of substance abuse and/or alcoholism.
About this study
Official title: A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sustained Release Encapsulated Bupivacaine (SKY0402) Administered as a Nerve Block in the Management of Postoperative Pain in Subjects Undergoing Bunionectomy
The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.
Read the detailed description
This Phase 2, multicenter, randomized, double blind, dose escalating/de-escalating study evaluated the safety, efficacy, and pharmacokinetics of a single dose of SKY0402 compared to a single 125 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing bunionectomy.
Up to 88 subjects were to be randomized in five consecutive cohorts. The dose of bupivacaine HCl (125 mg) was to remain constant for all cohorts. After completion of Cohort 1, the decision to increase or decrease the dose of SKY0402 was made by a Cohort Data Review Committee following a review of pharmacokinetic, safety, and selected efficacy data from the previous cohort.
Study drug was to be administered as an ankle block, with or without a tourniquet, between 1 hour before the induction of general anesthesia and 20 minutes before the end of general anesthesia. The ankle block procedure consisted of five injections via three skin entries targeting the following nerves: posterior tibial, sural, deep peroneal, superficial peroneal, and saphenous.
The use of intravenous fentanyl during general anesthesia was permitted, but was not to exceed 250 micrograms. The intraoperative use of morphine was prohibited. Postoperatively, subjects had access to both opioid and non-opioid supplemental pain medication under general guidelines. Blood samples for the determination of plasma bupivacaine concentrations were obtained at Baseline and at specified time points through 96 hours.
- Conditions
- Postoperative Pain
- Being tested
- SKY0402, Bupivacaine HCl
- Keywords
- Postoperative Pain, Bunionectomy, Analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKY0402Drug
Single dose of SKY0402 administered as a nerve block
Bupivacaine HClDrug
Single dose of 125 mg administered as a nerve block
| Study group | Role | What they receive |
|---|---|---|
| SKY0402 | Active comparator | Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg) Receives: Drug: 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: Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain
The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.
Measured: Through 96 hours postdose
Secondary outcomes (1)
Number of Patients With Adverse Events
All adverse events were to be recorded from the time of dosing through Day 8. Serious adverse events (SAEs) were to be recorded 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 2005
- Primary completionMar 2006
- Study completionDec 2006
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
- 58 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, Parica Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206595
- Sponsor's protocol ID
- SKY0402-C-203
- Status last verified
- Jan 2021
- First submitted
- 19 Sep 2010
- Last updated
- 25 Jan 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 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double Blind, Dose Escalating/ De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sustained Release Encapsulated Bupivacaine (SKY0402) Administered as a Nerve Block in the Management of Postoperative Pain in Subjects Undergoing Bunionectomy
- ClinicalTrials.gov ID
- NCT01206595
- Acronym / sponsor ID
- SKY0402-C-203
- Conditions
- Postoperative Pain
- Keywords
- Postoperative Pain, Bunionectomy, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Posted 15 May 2012
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 determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.
Detailed description
This Phase 2, multicenter, randomized, double blind, dose escalating/de-escalating study evaluated the safety, efficacy, and pharmacokinetics of a single dose of SKY0402 compared to a single 125 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing bunionectomy.
Up to 88 subjects were to be randomized in five consecutive cohorts. The dose of bupivacaine HCl (125 mg) was to remain constant for all cohorts. After completion of Cohort 1, the decision to increase or decrease the dose of SKY0402 was made by a Cohort Data Review Committee following a review of pharmacokinetic, safety, and selected efficacy data from the previous cohort.
Study drug was to be administered as an ankle block, with or without a tourniquet, between 1 hour before the induction of general anesthesia and 20 minutes before the end of general anesthesia. The ankle block procedure consisted of five injections via three skin entries targeting the following nerves: posterior tibial, sural, deep peroneal, superficial peroneal, and saphenous.
The use of intravenous fentanyl during general anesthesia was permitted, but was not to exceed 250 micrograms. The intraoperative use of morphine was prohibited. Postoperatively, subjects had access to both opioid and non-opioid supplemental pain medication under general guidelines. Blood samples for the determination of plasma bupivacaine concentrations were obtained at Baseline and at specified time points through 96 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKY0402 | Active comparator | Drug: SKY0402Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg) |
| Bupivacaine HCl | Active comparator | Drug: 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥18 years of age at the Screening Visit. NOTE: Eligible females were postmenopausal or surgically sterile, or, if of child bearing potential, were not pregnant or nursing, and they agreed to not become pregnant during the study by using acceptable means of contraception for at least 1 month before and 1 month after dosing, including any of the following: hormonal contraceptives (oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device (IUD), lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo a primary unilateral first metatarsal bunionectomy repair under general anesthesia, with or without internal fixation.
- NOTE: For the purpose of this protocol, all surgical procedures involving osteotomy of the first metatarsal (significant bone resection, excision, surgical fracture, etc.) or fusion of the first metatarsal phalangeal joint were considered qualified procedures, whether or not performed specifically to repair a bunion (hallus valgus deformity). Surgical techniques accompanied by minimal bone excision (e.g. cheilectomy) or procedures limited to soft tissue repair were not eligible for this study.
- American Society of Anesthesiology (ASA) Physical Class 1 or 2.
- Able and willing to comply with all study visits and procedures.
Key exclusion criteria (13 listed)
- Clinically significant electrocardiogram (ECG) abnormalities at Screening or on Day 1 (before dosing).
- Albumin and/or alpha 1 acid glycoprotein (AAG) below normal levels.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, might have increased the risk of surgery or complicated the subject's postoperative course.
- Opioid medication usage during the 7 day period preceding the administration of study drug.
- Current medical conditions that could have required treatment with analgesic medications in the postoperative period for pain that was not surgically related (e.g., rheumatoid arthritis).
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 |
|---|---|---|
| SKY0402Single dose of SKY0402 administered as a nerve block | Drug | SKY0402 |
| Bupivacaine HClSingle dose of 125 mg administered as a nerve block | Drug | Bupivacaine HCl |
Primary outcome
Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain
Time frame: Through 96 hours postdose
The primary efficacy endpoint was the time to first use of supplemental pain medication (opioid or non-opioid) postoperatively for surgical pain.
1 secondary outcome
Number of Patients 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 25 Jan 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
Parica Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKY0402 and Bupivacaine HCl in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc.
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 13 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 15 May 2012). 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?
Time to First Use of Supplemental Pain Medication Postoperatively for Surgical Pain (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 25 Jan 2021.