Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy - Full Text View

Sponsored by:	Pacira Pharmaceuticals, Inc
Information provided by:	Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00744848

Purpose

Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.

Condition	Intervention	Phase
Hemorrhoids	Drug: HCl Drug: DepoBupivacaine	Phase III

MedlinePlus related topics: Hemorrhoids

Drug Information available for: Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Pacira Pharmaceuticals, Inc:

Primary Outcome Measures:

Area under the curve (AUC) of NRS-R [ Time Frame: through 96 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs through Day 3 and SAEs through Day 30 [ Time Frame: through day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	August 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 100 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.	Drug: HCl 100 mg Bupivacaine HCl
2 Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.	Drug: DepoBupivacaine Single administration 300 mg SKY0402 in a 40-mL injection volume

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744848

Locations

United States, Alabama
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
Drug Research and Analysis Corporation
Montgomery, Alabama, United States, 36106
West Alabama Research Inc.
Birmingham, Alabama, United States, 35209
United States, California
Lotus Clinical Research - Huntington Memorial Hospital
Pasadena, California, United States, 91105
UCSD Medical Center
San Diego, California, United States, 92121
Accurate Clinical Trials
San Clemente, California, United States, 92672
United States, Florida
Colon and Rectal Disease Center
Orlando, Florida, United States, 32804
United States, Illinois
University of Illinois
Springfield, Illinois, United States, 62708-0787
United States, Indiana
Indiana University - Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Hospital
New York, New York, United States, 10029
United States, North Carolina
CTMG, Inc. - Pitt Medical Center
Greenville, North Carolina, United States, 27834
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Univ. Hospitals of Cleveland, Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
The Women's Hospital of Texas
Houston, Texas, United States, 77054
Medical Center Ambulatory Surgery Center
Houston, Texas, United States, 77054
Research Concepts, Ltd
Bellaire, Texas, United States, 77401
Roland Saenz
San Antonio, Texas, United States, 78205
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Pacira Pharmaceuticals, Inc

Investigators

Study Director:

Kay Warnott, RN, ACN-P

Pacira Pharmaceuticals, Inc

More Information

Responsible Party:	Pacira Pharmaceuticals, Inc. ( Kay Warnot, RN, Director of Clinical Research )
Study ID Numbers:	SIMPLE Hemorrhoidectomy 312
Study First Received:	August 28, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00744848
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pacira Pharmaceuticals, Inc:

hemorrhoids

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Vascular Diseases
Hemorrhoids

Bupivacaine
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009