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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01347853




Registration number
NCT01347853
Ethics application status
Date submitted
3/05/2011
Date registered
4/05/2011
Date last updated
8/02/2017

Titles & IDs
Public title
Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain
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
Secondary ID [1] 0 0
ROX 2003-01
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 - Ketorolac tromethamine
Treatment: Drugs - Placebo

Experimental: Ketorolac tromethamine -

Placebo comparator: Placebo -


Treatment: Drugs: Ketorolac tromethamine
30 mg intranasal post-surgery for up to 5 days total

Treatment: Drugs: Placebo
Intranasal post-surgery for up to 5 days total
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
Timepoint [1] 0 0
6 hours after drug administration
Secondary outcome [1] 0 0
Morphine sulfate consumption at 24 hours and 48 hours
Timepoint [1] 0 0
24 hours and 48 hours after drug administration
Secondary outcome [2] 0 0
Hourly Pain Intensity Difference (PID) scores.
Timepoint [2] 0 0
Hourly following the first dose of study medication up to 8 hours
Secondary outcome [3] 0 0
Quality of analgesia
Timepoint [3] 0 0
First dose of study medication on Day 1 to the first dose of MS by PCA
Secondary outcome [4] 0 0
Global assessment of pain control
Timepoint [4] 0 0
8 hours following first dose of study medication
Secondary outcome [5] 0 0
Onset and duration of pain relief
Timepoint [5] 0 0
8 hours following first dose of study medication

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01347853
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01347853