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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00266786




Registration number
NCT00266786
Ethics application status
Date submitted
16/12/2005
Date registered
19/12/2005
Date last updated
8/02/2017

Titles & IDs
Public title
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Scientific 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
Secondary ID [1] 0 0
ROX 2005-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Intranasal Ketorolac Tromethamine
Treatment: Drugs - Intranasal Placebo

Experimental: Intranasal Ketorolac Tromethamine -

Placebo Comparator: Intranasal Placebo -


Treatment: Drugs: Intranasal Ketorolac Tromethamine
Intranasal at 30mg

Treatment: Drugs: Intranasal Placebo
Intranasal Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Summed Pain Intensity Difference (SPID) on Day 1 - 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.
Timepoint [1] 0 0
6 hours after drug administration
Secondary outcome [1] 0 0
Pain intensity difference scores - 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.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Quality of analgesia - Quality of analgesia was assessed on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Global assessment of pain control - 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.
Timepoint [3] 0 0
8 hours following first dose of study medication
Secondary outcome [4] 0 0
Morphine sulfate consumption at 24, 48, and 72 hours
Timepoint [4] 0 0
24, 48, and 72 hours after drug administration

Eligibility
Key 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
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Egalet Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00266786
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lincoln Bynum, MD
Address 0 0
ICON Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications