Status:
COMPLETED
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Lead Sponsor:
Egalet Ltd
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
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 ketorola...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00266786
Start Date
December 1 2005
Last Update
February 8 2017
Active Locations (6)
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1
Methodist Hospital
Arcadia, California, United States, 91007
2
Glendale Adventist Medical Center
Glendale, California, United States, 91206
3
Clinical Management Services, Inc.
Pasadena, California, United States, 91105
4
Memorial Hermann Healthcare System
Houston, Texas, United States, 77024