Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
Information source: Luitpold Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Ketorolac tromethamine (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Luitpold Pharmaceuticals
Summary
This was a randomized, double-blind, placebo-controlled study in subjects who underwent
major surgery. Each subject's study participation consisted of a screening visit and a
treatment period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned
to receive intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI)
rating equaled at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study
drug every 8 hours for 48 hours and then 3 times daily for up to 5 calendar days in total;
the frequency of dosing could be reduced after 48 hours. Starting at the time of the first
dose of study drug and continuing for the first 48 hours after surgery, the subjects had
access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). After
PCA was no longer required, backup pain relief was provided by another standard nonsteroidal
anti-inflammatory drug (non-NSAID) analgesic regimen. If the subjects were discharged before
postoperative Day 4, they could self-medicate at home through postoperative Day 4. A safety
follow-up evaluation was conducted by telephone approximately 14 days after the end of
dosing in a subset of subjects (n = 60).
The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of
ketorolac administered for up to 5 days. The secondary objective was to evaluate the safety
and tolerability of this dosing regimen.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: The Summed Pain Intensity Difference (SPID) on Day 1
Secondary outcome: Morphine sulfate consumption at 24 hours and 48 hoursHourly Pain Intensity Difference (PID) scores. Quality of analgesia Global assessment of pain control Onset and duration of pain relief
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men or women, age 18 years or older.
- Body weight > or = to 100 pounds and < or = to 300 pounds.
- Women of childbearing potential must have a negative serum pregnancy test result.
- Able to provide written informed consent.
- At least moderate pain as determined by a PI score of > or = to 40 mm on a 100-mm
VAS.
- Expected to remain in the hospital for at least 48 hours with the possibility of
remaining for 5 days.
- Willing and able to comply with all testing and requirements defined in the protocol.
- Willing and able to complete the post-treatment visit.
Exclusion Criteria:
- Allergy or sensitivity to ketorolac or EDTA.
- Allergic reaction to aspirin or other NSAIDs.
- Current upper respiratory tract infection or other respiratory tract condition that
could interfere with the absorption of the nasal spray or with the assessment of
adverse events.
- Use of any intranasal (IN) product within 24 hours prior to study entry.
- Clinically significant abnormality on screening laboratory tests.
- History of cocaine use resulting in nasal mucosal damage.
- Active peptic ulcer disease, recent (defined as within 6 months) history of peptic
ulcer disease or gastrointestinal bleeding considered by the investigator to be
clinically significant.
- Advanced renal impairment (serum creatinine > 1. 5 mg/dL) or a risk for renal failure
due to volume depletion.
- A history of any other clinically significant medical problem, which in the opinion
of the investigator would interfere with study participation.
- Participation within 30 days of study entry or within 5 times the half- life,
whichever is longer, in another investigational drug study.
- Allergy or significant reaction to opioids.
- Pregnancy or breastfeeding.
- Previous participation in this study.
Locations and Contacts
Waikato Clinical Research, Hamilton, New Zealand
Additional Information
Starting date: June 2003
Last updated: May 3, 2011
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