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Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy

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ClinicalTrials.gov Identifier: NCT00529126
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Brief Summary:
Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: SKY0402 Drug: Bupivacaine HCl Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy
Study Start Date : September 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Experimental: SKY0402 high dose
SKY0402, single administration
Drug: SKY0402
SKY0402
Other Name: EXPAREL

Experimental: SKY0402 middle dose
SKY0402, single administration
Drug: SKY0402
SKY0402
Other Name: EXPAREL

Experimental: SKY0402 low dose
SKY0402, single administration
Drug: SKY0402
SKY0402
Other Name: EXPAREL

Active Comparator: Bupivacaine HCl
Bupivacaine HCl
Drug: Bupivacaine HCl
Bupivacaine HCl
Other Name: Marcaine 0.25% with epinephrine 1:200,000




Primary Outcome Measures :
  1. Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours [ Time Frame: 0 to 72 hours ]
    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?"


Secondary Outcome Measures :
  1. Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days [ Time Frame: Up to 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years of age and older at the Screening Visit.
  2. Applies to female subjects only: Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
  3. Scheduled to undergo 2- or 3-column excisional hemorrhoidectomy under general anesthesia using Milligan Morgan or Ferguson-type techniques, including modified approaches with specialized instruments, such as LigaSure™ or harmonic scalpel, with a cumulative incision length of a minimum 3 cm.
  4. American Society of Anesthesiology (ASA) Physical Class 1-3.
  5. Able and willing to comply with all study visits and procedures.
  6. Able to speak, read, and understand the language of the Informed Consent Form (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.
  7. Willing and capable of providing written informed consent.

Exclusion Criteria:

  1. Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
  2. Use of any of the following medications within the times specified before surgery:

    • Long-acting opioid medication within 3 days.
    • Any opioid medication within 24 hours.
  3. Concurrent painful physical condition that may require analgesic treatment in the postoperative period for pain that is not surgically related and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain).
  4. Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component.
  5. Body weight less than 50 kilograms (110 pounds).
  6. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
  7. Contraindication to epinephrine, such as concurrent administration of monoamine oxidase (MAO) inhibitors or antidepressants of amitriptyline 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.
  8. Contraindications to any of the pain-control agents planned for postoperative use (e.g., acetaminophen [paracetamol], oxycodone, morphine, ketorolac).
  9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, 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.
  10. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
  12. 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, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.

    In addition, the subject will be ineligible to receive study drug if he or she meets the following criteria during surgery:

  13. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course.
  14. A cumulative incision length less than 3 cm.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529126


Locations
United States, California
Accurate Clinical Trials, Inc.
San Clemente, California, United States, 92673
United States, Florida
University of Miami/Jackson Memorial
Miami, Florida, United States, 33136
United States, Texas
The Women's Hospital of Texas
Houston, Texas, United States, 77054
United States, Washington
Multicare Health Systems Laboratories
Tacoma, Washington, United States, 98405
Georgia
JSC Imereti Regional Clinical Hospital of the Name A. Dzotsenidze
Kutaisi, Georgia, 4600
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia, 0159
Socieety with limited responsibility Proctology Center
Tbilisi, Georgia, 0160
Sponsors and Collaborators
Pacira Pharmaceuticals, Inc
Investigators
Study Director: Erol Onel, MD Pacira Pharmaceuticals, Inc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00529126     History of Changes
Other Study ID Numbers: SKY0402C209
First Posted: September 14, 2007    Key Record Dates
Results First Posted: August 6, 2013
Last Update Posted: August 6, 2013
Last Verified: July 2013

Keywords provided by Pacira Pharmaceuticals, Inc:
hemorrhoidectomy
pain
Postoperative
analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents