Double-Blind, Multicenter, Study Comparing the Efficacy and Safety of OMS103HP With Vehicle Irrigation Solution in Subjects Undergoing Meniscectomy

NCT00624845 | Completed Phase 2

• 1 other identifier: C07-004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.

Conditions

Postoperative Pain

Keywords

Meniscectomy

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the mean VAS at 24 hours postoperatively.

  24 hours

Study Arms (2)

Drug

EXPERIMENTAL

Drug: OMS103HP

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

OMS103HP DRUG

Maximum 6 bags of OMS103HP irrigation solution

Drug

Vehicle DRUG

Maximum of 6 bags of vehicle irrigation solution

Vehicle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has voluntarily signed informed consent form, including HIPAA Authorization.
• Subject is ≥ 18 and ≤ 75 years of age.
• Subject is in good general health with a traumatic or degenerative meniscal cartilage injury (full tear) that occurred at least 14 days prior to the day of arthroscopic surgery.
• Subject is undergoing unilateral meniscectomy.
• Subject's physical examination is within normal limits or examination is clinically nonsignificant as determined by the Investigator, and subject is in good general health.
• Subject's laboratory evaluations are within normal limits or evaluations are clinically nonsignificant as determined by the Investigator.
• Subject, if female and of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) agrees to use an effective method of birth control for the duration of her study involvement.
• Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 (a normal healthy patient) or PS-2 (a patient with mild systemic disease that results in no functional limitation). See Appendix VI.

You may not qualify if:

• Subject is able to be proficient in the use of the ePRO device (documented at the site).
• Subject with significant arthritis (\>2 on the Kellgren-Lawrence Scale).
• Subject with a history of reactive synovial disease.
• Subject with current, or history of, complex regional pain syndrome (Type I, i.e., reflex sympathetic dystrophy, or Type II, i.e., causalgia), chronic pain, attendance at a chronic pain clinic, or neurologic disorder associated with any sensory deficit of the lower extremities.
• Subject with current, or history of fibromyalgia.
• Subject taking ANY ANALGESIC (including salicylates, opioids, propoxyphene, etc.) on the day of surgery from 12:00 A.M. until after the procedure, except for medications authorized by the Investigator or delegated staff.
• Subject taking any of the following medications within the stated time frames prior to the day of surgery.
• Amitriptyline within 30 days
• More than two doses of sumatriptan, (or any other drug in the triptan class), ondansetron, or other prescription serotonergic or histaminic drug within 14 days
• More than two doses of any oral, parenteral, or intravenous steroids (e.g., dexamethasone for antiemetic prophylaxis) within 3 months
• More than two doses of oxymetazoline or other nasal decongestant/cold/cough/allergy medication (including loratadine) within 7 days
• More than two doses of ketoprofen or other NSAID (including COX-2 inhibitors) within 7 days (except for piroxicam, as indicated below)
• Subject who has taken more than two doses of opioid pain medication within the prior seven days of surgery or chronic use of opioid pain medications for greater than 6 weeks within the prior year
• More than two doses of piroxicam within 14 days
• Subject with a history of intra-articular corticosteroid injection in the operative knee within the two months prior to the meniscectomy

Sponsors & Collaborators

• Omeros Corporation: lead

Study Sites (8)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Visions Clinical Research

Tucson, Arizona, 85712, United States

Location

Kerlan-Jobe Orthopaedic Clinic - Westchester

Los Angeles, California, 90045, United States

Location

Advanced Orthopedic and Sports Medicine Specialists

Aurora, Colorado, 80014, United States

Location

Colorado Orthopedic Consultants

Englewood, Colorado, 80110, United States

Location

Greater Chesapeake Orthopaedic Associates

Baltimore, Maryland, 21218, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Unlimited Research

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

OMS 103HP

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Scott Houston

  Omeros Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

US (8)