Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
1 other identifier
interventional
204
1 country
20
Brief Summary
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2008
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 28, 2008
CompletedFirst Posted
Study publicly available on registry
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
August 6, 2013
CompletedAugust 6, 2013
July 1, 2013
6 months
August 28, 2008
November 23, 2011
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
through 96 hours
Secondary Outcomes (1)
Number of Participants With Adverse Events (AEs) Through Day 3 and Serious Adverse Events (SAEs) Through Day 30
through day 30
Study Arms (2)
Bupivacaine HCl
ACTIVE COMPARATOR100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
SKY0402
OTHER300 mg SKY0402 in a 40-mL injection volume. A single dose of study drug was administered intraoperatively (at the end of surgery) via local infiltration.
Interventions
100 mg Bupivacaine HCl
Single administration 300 mg SKY0402 in a 40-mL injection volume
Eligibility Criteria
You may qualify if:
- Male or female equal or greater than 18 years of age at Screening
- Female subjects: postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery, nonheterosexual lifestyle, or strictly monogamous relationship with a partner who has had a vasectomy.
- Scheduled to undergo 2-or3-column excisional hemorrhoidectomy
- American Society of Anesthesiology (ASA) Physical Class 1-4
- Able and willing to complete with all study visits and procedures
- Able to speak, read, and understand the language of all study forms and instruments used for collecting subject-reported outcomes to provide accurate study assessments
- Willing and capable of provide written informed consent.
You may not qualify if:
- Pregnant, nursing or planning to become pregnant during the study period
- Use of any long-acting opioid medication within 3 days of surgery or any opioid medication with 24 hours of surgery.
- Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain not strictly related to the procedure or that may interfere with study assessments.
- Single-column hemorrhoidectomy
- Body weight less than 50 kg (110 pounds)
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, or any ingredient of the medications administered in this study (e.g., sulfites in Marcaine with epinephrine)
- contraindication to epinephrine
- contraindication to any of the pain-control agents planned for postoperative use
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration
- History of, known addiction, or abuse of illicit drugs, prescription medicines or alcohol within the past 2 years.
- Uncontrolled anxiety schizophrenic, or other psychiatric disorder that may interfere with study assessments or compliance.
- Significant medical conditions or laboratory results that 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.
- Any clinically significant event or condition uncovered during surgery
- A cumulative incision length less than 3 cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
West Alabama Research Inc.
Birmingham, Alabama, 35209, United States
Drug Research and Analysis Corporation
Montgomery, Alabama, 36106, United States
Lotus Clinical Research - Huntington Memorial Hospital
Pasadena, California, 91105, United States
Accurate Clinical Trials
San Clemente, California, 92672, United States
UCSD Medical Center
San Diego, California, 92121, United States
Colon and Rectal Disease Center
Orlando, Florida, 32804, United States
University of Illinois
Springfield, Illinois, 62708-0787, United States
Indiana University - Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
CTMG, Inc. - Pitt Medical Center
Greenville, North Carolina, 27834, United States
Univ. Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, 44106, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Research Concepts, Ltd
Bellaire, Texas, 77401, United States
Medical Center Ambulatory Surgery Center
Houston, Texas, 77054, United States
The Women's Hospital of Texas
Houston, Texas, 77054, United States
Roland Saenz
San Antonio, Texas, 78205, United States
Multicare Health System
Tacoma, Washington, 98405, United States
Related Publications (1)
Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
PMID: 22900785DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Executive Medical Director
- Organization
- Pacira Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Kay Warnott, RN, ACN-P
Pacira Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2008
First Posted
September 1, 2008
Study Start
August 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
August 6, 2013
Results First Posted
August 6, 2013
Record last verified: 2013-07