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

Egalet

Status and phase

Completed

Phase 3

Conditions

Postoperative Pain

Treatments

Drug: Intranasal Ketorolac Tromethamine

Drug: Intranasal Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00266786

ROX 2005-01

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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