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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00266786
Recruitment Status : Completed
First Posted : December 19, 2005
Last Update Posted : February 8, 2017
Sponsor:
Information provided by:
Egalet Ltd

Tracking Information
First Submitted Date  ICMJE December 16, 2005
First Posted Date  ICMJE December 19, 2005
Last Update Posted Date February 8, 2017
Study Start Date  ICMJE December 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2005)
Summed pain intensity difference at 6 hours after drug administration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2005)
  • Hourly pain intensity difference scores
  • Quality of analgesia
  • Global assessment of pain control
  • Morphine sulfate consumption at 24, 48, and 72 hours
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Intranasal Ketorolac Tromethamine
    Intranasal at 30mg
  • Drug: Intranasal Placebo
    Intranasal Placebo
Study Arms  ICMJE
  • Experimental: Intranasal Ketorolac Tromethamine
    Intervention: Drug: Intranasal Ketorolac Tromethamine
  • Placebo Comparator: Intranasal Placebo
    Intervention: Drug: Intranasal Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2006)
321
Original Enrollment  ICMJE
 (submitted: December 16, 2005)
300
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00266786
Other Study ID Numbers  ICMJE ROX 2005-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Bregman, M.D., Ph.D., Luitpold Pharmaceuticals, Inc.
Study Sponsor  ICMJE Egalet Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lincoln Bynum, MD ICON Clinical Research
PRS Account Egalet Ltd
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP