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

NCT00529126 | Completed Phase 2 Results

• 1 other identifier: SKY0402C209
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Postoperative Pain

Keywords

hemorrhoidectomy; pain; Postoperative; analgesia

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 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?"

  0 to 72 hours

Secondary Outcomes (1)

• Participants With Adverse Events Through 72 Hours or Serious Adverse Events Through 30 Days

  Up to 30 days

Study Arms (4)

SKY0402 high dose

EXPERIMENTAL

SKY0402, single administration

Drug: SKY0402

SKY0402 middle dose

EXPERIMENTAL

SKY0402, single administration

Drug: SKY0402

SKY0402 low dose

EXPERIMENTAL

SKY0402, single administration

Drug: SKY0402

Bupivacaine HCl

ACTIVE COMPARATOR

Bupivacaine HCl

Drug: Bupivacaine HCl

Interventions

SKY0402 DRUG

SKY0402

Also known as: EXPAREL

SKY0402 high dose; SKY0402 low dose; SKY0402 middle dose

Bupivacaine HCl DRUG

Bupivacaine HCl

Also known as: Marcaine 0.25% with epinephrine 1:200,000

Bupivacaine HCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age and older at the Screening Visit.
• 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.
• 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.
• American Society of Anesthesiology (ASA) Physical Class 1-3.
• Able and willing to comply with all study visits and procedures.
• 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.
• Willing and capable of providing written informed consent.

You may not qualify if:

• Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
• 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.
• 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).
• Single-column hemorrhoidectomy or hemorrhoidectomy without an internal component.
• Body weight less than 50 kilograms (110 pounds).
• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or to opioid medication.
• 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.
• Contraindications to any of the pain-control agents planned for postoperative use (e.g., acetaminophen \[paracetamol\], oxycodone, morphine, ketorolac).
• 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.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
• 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:

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (7)

Accurate Clinical Trials, Inc.

San Clemente, California, 92673, United States

Location

University of Miami/Jackson Memorial

Miami, Florida, 33136, United States

Location

The Women's Hospital of Texas

Houston, Texas, 77054, United States

Location

Multicare Health Systems Laboratories

Tacoma, Washington, 98405, United States

Location

JSC Imereti Regional Clinical Hospital of the Name A. Dzotsenidze

Kutaisi, 4600, Georgia

Location

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, 0159, Georgia

Location

Socieety with limited responsibility Proctology Center

Tbilisi, 0160, Georgia

Location

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: 22900785 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Executive Medical Director
• Organization: Pacira Pharmaceuticals, Inc.

ErolOnel@pacira.com

203-837-6500

Study Officials

• Erol Onel, MD

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: July 1, 2008
• Last Updated: March 4, 2021
• Results First Posted: August 6, 2013

Record last verified: 2021-02

Locations

GE (3); US (4)