Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01351090
Ethics application status
Date submitted
9/05/2011
Date registered
10/05/2011
Date last updated
18/10/2012

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
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
Sex
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
1/10/2007
Sample size
Target
Accrual to date
Final
127
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
Trial website
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 information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01351090