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

This study has been completed.
Sponsor:
Information provided by:
Egalet Ltd
ClinicalTrials.gov Identifier:
NCT00266786
First received: December 16, 2005
Last updated: February 6, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention Phase
Postoperative Pain Drug: Intranasal Ketorolac Tromethamine Drug: Intranasal Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Egalet Ltd:

Primary Outcome Measures:
  • The Summed Pain Intensity Difference (SPID) on Day 1 [ Time Frame: 6 hours after drug administration ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained every hour following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 6 hours.


Secondary Outcome Measures:
  • Pain intensity difference scores [ Time Frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.

  • Quality of analgesia [ Time Frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours ]
    Quality of analgesia was assessed on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.

  • Global assessment of pain control [ Time Frame: 8 hours following first dose of study medication ]
    A global evaluation of pain control was conducted once daily at bedtime using a 5-point categorical scale on which 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.

  • Morphine sulfate consumption at 24, 48, and 72 hours [ Time Frame: 24, 48, and 72 hours after drug administration ]

Enrollment: 321
Study Start Date: December 2005
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal Ketorolac Tromethamine Drug: Intranasal Ketorolac Tromethamine
Intranasal at 30mg
Placebo Comparator: Intranasal Placebo Drug: Intranasal Placebo
Intranasal Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 that could 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 or gastrointestinal 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266786

Locations
United States, California
Methodist Hospital
Arcadia, California, United States, 91007
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Clinical Management Services, Inc.
Pasadena, California, United States, 91105
United States, Texas
Memorial Hermann Healthcare System
Houston, Texas, United States, 77024
Houston Perinatal Associates
Houston, Texas, United States, 77054
New Zealand
Waikato Clinical Research
Hamilton, New Zealand
Sponsors and Collaborators
Egalet Ltd
Investigators
Study Chair: Lincoln Bynum, MD ICON Clinical Research
  More Information

Responsible Party: David Bregman, M.D., Ph.D., Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00266786     History of Changes
Other Study ID Numbers: ROX 2005-01
Study First Received: December 16, 2005
Last Updated: February 6, 2017

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017