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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01351090




Registration number
NCT01351090
Ethics application status
Date submitted
9/05/2011
Date registered
9/05/2011
Date last updated
14/09/2012

Titles & IDs
Public title
Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain
Scientific title
A Phase 2, 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 2001-03
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 - Ketorolac tromethamine
Treatment: Drugs - Placebo

Experimental: Ketorolac tromethamine (5%) -

Experimental: Ketorolac tromethamine (15%) -

Placebo Comparator: Placebo -


Treatment: Drugs: Ketorolac tromethamine
10 mg Intranasal (2 x 100 uL of a 5% solution)

Treatment: Drugs: Ketorolac tromethamine
30 mg Intranasal (2 x 100 uL of a 15% solution)

Treatment: Drugs: Placebo
Intranasal

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

Outcomes
Primary outcome [1] 0 0
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours
Timepoint [1] 0 0
8-hour intervals from the start of dosing through 24 hours
Secondary outcome [1] 0 0
Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
Timepoint [1] 0 0
8-hour intervals from the start of dosing through 48 hours
Secondary outcome [2] 0 0
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
Timepoint [2] 0 0
8-hour intervals from 24 hours after the start of dosing through 48 hours
Secondary outcome [3] 0 0
Pain Intensity Difference (PID) 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 [3] 0 0
6 hours after study drug administration

Eligibility
Key inclusion criteria
- Men or women, age 18 years or older

- Body weight > or = 100 pounds (45.4 kg) and < or = 300 pounds (136.1 kg)

- Women of childbearing potential must have had a negative serum pregnancy test result
prior to entry into the study

- Able to provide written informed consent

- At least moderate pain as determined by a PI score of > or = 40 mm on a 100-mm VAS

- Expected to remain in the hospital for at least 48 hours

- Willing and able to comply with all testing and requirements defined in the protocol

- Willing and able to complete the posttreatment visit
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)

- 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 the absorption of the nasal spray or with the assessment of
adverse events

- Use of any 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) gastrointestinal
bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal
bleeding

- Advanced renal impairment 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 2
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
New Zealand
State/province [1] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
American Regent, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This was a randomized, double blind, placebo-controlled study in subjects who have undergone
major surgery. Each subject's study participation consisted of a screening visit, a 2-day
treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned
to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain
intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter,
subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain
not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered
via patient controlled analgesia (PCA).

The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN)
doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and
tolerability of this dosing regimen.
Trial website
https://clinicaltrials.gov/show/NCT01351090
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lincoln Bynum, MD
Address 0 0
ICON Development Solutions
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

No data has been provided for results reporting
Summary results
Other publications