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Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

This study is currently recruiting participants.
Verified by Pacira Pharmaceuticals, Inc, August 2008

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:   January 2009
Estimated Primary Completion Date:   November 2008 (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     Recruiting
      Montgomery, Alabama, United States, 36106
      Contact: Mary Jones     334-265-2700     mjons@drugresearch.com    
      Contact: Wrenn McGhee     334-265-2700     wmcghee@drugresearch.com    
      Principal Investigator: Barry Wesley, MD            
      Sub-Investigator: Henry Frazer, MD            
Drug Research and Analysis Corporation     Recruiting
      Montgomery, Alabama, United States, 36106
      Contact: Sandy Meriwether     334-265-2700     smeriwether@drugresearch.com    
      Contact: Wrenn McGhee     334-265-2700     wmcghee@drugresearch.com    
      Principal Investigator: Daniel Daly, MD            
      Sub-Investigator: Henry Frazer, MD            
United States, California
Lotus Clinical Research - Huntington Memorial Hospital     Recruiting
      Pasadena, California, United States, 91105
      Contact: Lakshmi Damerla     818-863-4196     lakshmi@lotuscr.com    
      Contact: Gloria Chou     818-863-4165     gloria@lotuscr.com    
      Principal Investigator: Neil Singla, MD            
UCSD Medical Center     Recruiting
      San Diego, California, United States, 92121
      Contact: Barbara Andrews     858-822-6517     bqandrews@ucsd.edu    
      Principal Investigator: Sonia Ramamoorthy, MD            
Accurate Clinical Trials     Not yet recruiting
      San Clemente, California, United States, 92672
      Contact: Justin Deck     949-305-7008     jusstindeck@accurateclinicaltrials.net    
      Contact: Sara Love     949-305-7008     saralove@accurateclinicaltrials.net    
      Principal Investigator: Kevin Jones, MD            
United States, Indiana
Indiana University - Wishard Memorial Hospital     Not yet recruiting
      Indianapolis, Indiana, United States, 46202
      Contact: Maryanne Bowyer-Cherry     317-274-0172     mbowyer@iupui.edu    
      Contact: Sarah Dutkevitch     317-274-5495     sdutkevi@iupui.edu    
      Principal Investigator: Virgilio George, MD            
United States, Kentucky
University of Louisville     Recruiting
      Louisville, Kentucky, United States, 40202
      Contact: Anna Williford     502-852-8589     aowill01@gwise.louisville.edu    
      Contact: Wendy Kaiser     502-852-8589     wlkais03@gwise.louisville.edu    
      Principal Investigator: Susan Galandiiuk, MD            
United States, New York
Montefiore Medical Center     Not yet recruiting
      Great Neck, New York, United States
      Contact: Katie Fahey     718-920-5961     kfahey@montefiore.org    
      Principal Investigator: Arnold Berlin, MD            
      Principal Investigator: Ronald Kaleya, MD            
United States, North Carolina
CTMG, Inc. - Pitt Medical Center     Recruiting
      Greenville, North Carolina, United States
      Contact: Janell Hazelton     252-752-8553     jhazelton@ctmginc.com    
      Contact: Brad Wiggs     252-752-8553     bwiggs@ctmginc.com    
      Principal Investigator: Wade Naziri, MD            
      Principal Investigator: Patrick Brillant, MD            
Duke University Medical Center     Recruiting
      Raleigh, North Carolina, United States
      Contact: Sherri Jarvis     919-681-6898     sherri.jarvis@duke.edu    
      Contact: Christy Walters     919-668-5499     walte011@mc.duke.edu    
      Principal Investigator: Christopher Mantyh, MD            
      Sub-Investigator: Alexander Perez, MD            
United States, Ohio
Univ. Hospitals of Cleveland, Case Medical Center     Not yet recruiting
      Cleveland, Ohio, United States
      Contact: Mary Ann Draves     216-844-4724     maryann.draves@uhhospitals.org    
      Contact: Lisa Sanuk, BSN     216-844-7773     lisa.sanuk@uhhospitals.org    
      Principal Investigator: Bradley Champagne, MD            
United States, Tennessee
Holston Medical Group     Recruiting
      Kingsport, Tennessee, United States
      Contact: Mary Glass     423-578-1530     mag@hmgkpt.com    
      Principal Investigator: Robert Rogers, MD            
United States, Texas
The Women's Hospital of Texas     Recruiting
      Houston, Texas, United States, 77054
      Contact: Brenda Sindylek     832-221-6898     gsindylek@sbcglobal.net    
      Principal Investigator: Howard Miller, MD            
Medical Center Ambulatory Surgery Center     Recruiting
      Houston, Texas, United States, 77054
      Contact: Brenda Sindylek     832-221-6898     gsindylek@sbcglobal.net    
      Principal Investigator: Bailey, MD            
      Principal Investigator: Howard Miller, MD            
Research Concepts, Ltd     Recruiting
      Bellaire, Texas, United States, 77401
      Contact: Pam Lindley, LVN, RRT     713-242-3436        
      Contact: Staci Maroney     540-904-5096        
      Principal Investigator: Harold Minkowitz, MD            
United States, Washington
Multicare Health System     Recruiting
      Tacoma, Washington, United States
      Contact: Carole Burton     253-403-7251     carole.burton@multicare.org    
      Contact: Wendy Camahan     253-403-7249     wendy.camahan@multicare.org    
      Principal Investigator: Richard Shine, MD            

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
First Received:   August 28, 2008
Last Updated:   August 29, 2008
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 October 24, 2008




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