Postoperative PainPhase 2NCT00807209
Dose Finding Posterolateral Thoracotomy Study
A Phase 2 study testing Low Dose SKY0402, High Dose SKY0402 and Fentanyl via PCA in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 5 sites in United States.
Trial summary
To review safety and effectiveness of two doses compared to current standard of care. 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?
- Low Dose SKY0402, High Dose SKY0402 and Fentanyl via PCA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2008to Feb 2009
- 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
- Men and women ≥ 18 years of age at the Screening Visit.
- Scheduled to undergo a thoracotomy of at least 3 inches of intercostal incisional length or requiring insertion of an inter-rib spreader/retractor for a primary thoracic non-infectious indication under general anesthesia.
- Able and willing to receive an epidural catheter for the treatment of postoperative pain.
- American Society of Anesthesiology (ASA) Physical Class 1-4.
- 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
- Known metastatic disease of any type.
- Known pulmonary infectious disease.
- Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
- Use of any of the following medications within the times specified before surgery:
- Long-acting opioids within 3 days.
- Any opioid medication within 24 hours.
Show all 14Show fewer
- Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.
- Body weight less than 50 kilograms (110 pounds).
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.
- Contraindication to epinephrine, such as concurrent administration of ergot-type drugs, monoamine oxidase (MAO) inhibitors or antidepressants of tryptoline or imipramine types, conditions where the production or exacerbation of tachycardia could prove fatal (e.g., poorly controlled thyrotoxicosis or severe heart disease), or any other pathological conditions that might be aggravated by the effects of epinephrine.
- Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational product, 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.
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance with the protocol.
- Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, sever renal impairment, advanced diabetes, co-morbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Memorial Hermann - Memorial City Medical Center
Houston, Texas, 77024
Houston NW Medical Center
Houston, Texas, 77053
Florida Hospital
Orlando, Florida, 32801
Lotus Clinical Research
Pasadena, California, 91105
Multicare Health System
Tacoma, Washington, 98405
About this study
Official title: A Phase 2 Open-Label, Parallel Group, Randomized, Dose-Finding Study to Assess the Efficacy and Safety of Intercostal SKY0402 in Subjects Undergoing Posterolateral Thoracotomy
To review safety and effectiveness of two doses compared to current standard of care.
Read the detailed description
Evaluate the efficacy of intercostal nerve block using SKY0402 compared to epidural bupivacaine HCl in subjects undergoing posterolateral thoracotomy. The primary outcome metric for this will be the amount of rescue PCA fentanyl administered for breakthrough pain during the first 72 hours.
- Conditions
- Postoperative Pain
- Being tested
- Low Dose SKY0402, High Dose SKY0402, Placebo, Fentanyl via PCA, Bupivacaine via epidural
- Keywords
- Pain, postoperative, thoracotomy
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose SKY0402Drug
Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)
High Dose SKY0402Drug
Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal)
PlaceboDrug
Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)
Fentanyl via PCADrug
Fentanyl via PCA
Bupivacaine via epiduralDrug
Bupivacaine via epidural
| Study group | Role | What they receive |
|---|---|---|
| High Dose SKY0402 | Experimental | Not described Receives: Drug: High Dose SKY0402; Drug: Fentanyl via PCA; Drug: Bupivacaine via epidural |
| Standard of Care | Active comparator | Not described Receives: Drug: Placebo; Drug: Fentanyl via PCA; Drug: Bupivacaine via epidural |
| Low Dose SKY0402 | Experimental | Not described Receives: Drug: Low Dose SKY0402; Drug: Fentanyl via PCA; Drug: Bupivacaine via epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.
The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.
Measured: 72 hours
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 startDec 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Sponsor decision unrelated to safety
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
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kay Warnott, RN, ACN-P, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807209
- Sponsor's protocol ID
- SKY0402C211
- Status last verified
- Nov 2011
- First submitted
- 9 Dec 2008
- Last updated
- 15 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label, Parallel Group, Randomized, Dose-Finding Study to Assess the Efficacy and Safety of Intercostal SKY0402 in Subjects Undergoing Posterolateral Thoracotomy
- ClinicalTrials.gov ID
- NCT00807209
- Acronym / sponsor ID
- SKY0402C211
- Conditions
- Postoperative Pain
- Keywords
- Pain, postoperative, thoracotomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision unrelated to safety
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Dec 2008 (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.
To review safety and effectiveness of two doses compared to current standard of care.
Detailed description
Evaluate the efficacy of intercostal nerve block using SKY0402 compared to epidural bupivacaine HCl in subjects undergoing posterolateral thoracotomy. The primary outcome metric for this will be the amount of rescue PCA fentanyl administered for breakthrough pain during the first 72 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose SKY0402 | Experimental | Drug: High Dose SKY0402, Drug: Fentanyl via PCA, Drug: Bupivacaine via epidural |
| Standard of Care | Active comparator | Drug: Placebo, Drug: Fentanyl via PCA, Drug: Bupivacaine via epidural |
| Low Dose SKY0402 | Experimental | Drug: Low Dose SKY0402, Drug: Fentanyl via PCA, Drug: Bupivacaine via epidural |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years of age at the Screening Visit.
- Scheduled to undergo a thoracotomy of at least 3 inches of intercostal incisional length or requiring insertion of an inter-rib spreader/retractor for a primary thoracic non-infectious indication under general anesthesia.
- Able and willing to receive an epidural catheter for the treatment of postoperative pain.
- American Society of Anesthesiology (ASA) Physical Class 1-4.
- Able and willing to comply with all study visits and procedures.
Key exclusion criteria (14 listed)
- Known metastatic disease of any type.
- Known pulmonary infectious disease.
- Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
- Use of any of the following medications within the times specified before surgery:
- Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.
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 |
|---|---|---|
| Low Dose SKY0402Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 75mg SKY0402 (25 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal) | Drug | Low Dose SKY0402 |
| High Dose SKY0402Bupivacaine, 15 mg/mL via epidural PLUS single total administration of 150 mg (50 mg to each of three segments) in 4 mL volume each for a total of 12 mL via nerve block (intercostal) | Drug | High Dose SKY0402 |
| PlaceboBupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal) | Drug | Standard of Care |
| Fentanyl via PCAFentanyl via PCA | Drug | High Dose SKY0402, Low Dose SKY0402, Standard of Care |
| Bupivacaine via epiduralBupivacaine via epidural | Drug | High Dose SKY0402, Low Dose SKY0402, Standard of Care |
Primary outcome
Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.
Time frame: 72 hours
The primary outcome metric was to be the amount of rescue epidural fentanyl administered for breakthrough pain during the first 72 hours postoperatively. Patient-controlled analgesia (PCA) fentanyl intake was to be summarized for each treatment group as time to first use of rescue PCA fentanyl, amount of PCA fentanyl administered over 72 hours, and total amount of PCA fentanyl administered through a number of time intervals. However, efficacy analyses were not performed because the study was terminated early after only three subjects were enrolled.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- 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, ACN-P study director
Pacira Pharmaceuticals, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose SKY0402, High Dose SKY0402 and Fentanyl via PCA in people with Postoperative Pain, run by Pacira Pharmaceuticals, Inc at 5 sites 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 7 inclusion and 14 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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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?
Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours. (time frame: 72 hours). 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 15 May 2012.