Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery

Last updated: February 6, 2017
Sponsor: Egalet Ltd
Overall Status: Completed

Phase

3

Condition

Post-surgical Pain

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT00266786
ROX 2005-01
  • Ages 18-64
  • All Genders

Study Summary

Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile.

Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing.

Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women age 18 through 64 years

  • Major abdominal surgery

  • Body weight ≥ 100 and ≤ 300 pounds

  • Negative serum pregnancy test

  • Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale

  • Minimum 48 hour hospital stay and 5 day maximum stay

  • Able to provide written informed consent

  • Willing and able to comply with all testing requirements of the protocol

Exclusion

Exclusion Criteria:

  • Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)

  • Allergy or significant reaction to opioids

  • Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)

  • Current upper respiratory tract infection or other respiratory tract condition thatcould interfere with absorption of the nasal spray or adverse event assessment

  • Use of any intranasal product in past 24 hours

  • Clinically significant abnormality on screening lab tests

  • History of cocaine use

  • Active peptic ulcer disease or significant history of peptic ulcer disease orgastrointestinal bleeding

  • Advanced renal impairment or risk for renal failure

  • History of other medical problems that could interfere with the study participation

  • Pregnancy or breastfeeding

  • Participation in another investigational study within past 30 days

Study Design

Total Participants: 321
Study Start date:
December 01, 2005
Estimated Completion Date:

Connect with a study center

  • Waikato Clinical Research

    Hamilton,
    New Zealand

    Site Not Available

  • Methodist Hospital

    Arcadia, California 91007
    United States

    Site Not Available

  • Glendale Adventist Medical Center

    Glendale, California 91206
    United States

    Site Not Available

  • Clinical Management Services, Inc.

    Pasadena, California 91105
    United States

    Site Not Available

  • Houston Perinatal Associates

    Houston, Texas 77054
    United States

    Site Not Available

  • Memorial Hermann Healthcare System

    Houston, Texas 77024
    United States

    Site Not Available

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