- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807209
Dose Finding Posterolateral Thoracotomy Study
April 15, 2012 updated by: Pacira Pharmaceuticals, Inc
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Pasadena, California, United States, 91105
- Lotus Clinical Research
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-
Florida
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Orlando, Florida, United States, 32801
- Florida Hospital
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-
Texas
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Houston, Texas, United States, 77024
- Memorial Hermann - Memorial City Medical Center
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Houston, Texas, United States, 77053
- Houston NW Medical Center
-
-
Washington
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Tacoma, Washington, United States, 98405
- MultiCare Health System
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
|
Fentanyl via PCA
Bupivacaine via epidural
Bupivacaine, 15 mg/mL per epidural PLUS administration of 4 mL Placebo to each of three nerves for a total of 12 mL (intercostal)
|
Experimental: High Dose SKY0402
|
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)
Fentanyl via PCA
Bupivacaine via epidural
|
Experimental: Low Dose SKY0402
|
Fentanyl via PCA
Bupivacaine via epidural
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kay Warnott, RN, ACN-P, Pacira Pharmaceuticals, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
December 9, 2008
First Submitted That Met QC Criteria
December 9, 2008
First Posted (Estimate)
December 11, 2008
Study Record Updates
Last Update Posted (Estimate)
May 15, 2012
Last Update Submitted That Met QC Criteria
April 15, 2012
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Bupivacaine
Other Study ID Numbers
- SKY0402C211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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