Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
This study has been completed.
Sponsor:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00744848
First received: August 28, 2008
Last updated: November 6, 2011
Last verified: November 2011
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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: Bupivacaine HCl Drug: SKY0402 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Supportive Care |
| 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 |
Resource links provided by NLM:
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:
- Number of participants with AEs through Day 3 and SAEs through Day 30 [ Time Frame: through day 30 ] [ Designated as safety issue: Yes ]
| Enrollment: | 220 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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: Bupivacaine HCl
100 mg Bupivacaine HCl
|
|
2
Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
|
Drug: SKY0402
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 | |
| West Alabama Research Inc. | |
| Birmingham, Alabama, United States, 35209 | |
| Drug Research and Analysis Corporation | |
| Montgomery, Alabama, United States, 36106 | |
| United States, California | |
| Lotus Clinical Research - Huntington Memorial Hospital | |
| Pasadena, California, United States, 91105 | |
| Accurate Clinical Trials | |
| San Clemente, California, United States, 92672 | |
| UCSD Medical Center | |
| San Diego, California, United States, 92121 | |
| 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 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| CTMG, Inc. - Pitt Medical Center | |
| Greenville, North Carolina, United States, 27834 | |
| 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 | |
| Research Concepts, Ltd | |
| Bellaire, Texas, United States, 77401 | |
| Medical Center Ambulatory Surgery Center | |
| Houston, Texas, United States, 77054 | |
| The Women's Hospital of Texas | |
| Houston, Texas, United States, 77054 | |
| 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
No publications provided
| Responsible Party: | Pacira Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00744848 History of Changes |
| Other Study ID Numbers: | SIMPLE Hemorrhoidectomy 312 |
| Study First Received: | August 28, 2008 |
| Last Updated: | November 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pacira Pharmaceuticals, Inc:
|
hemorrhoids |
Additional relevant MeSH terms:
|
Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases Bupivacaine Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013