Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06273813
Registration number
NCT06273813
Ethics application status
Date submitted
15/02/2024
Date registered
23/02/2024
Date last updated
23/02/2024
Titles & IDs
Public title
Treatment of Topical Ketorolac Gel in Acute Gouty Flare
Query!
Scientific title
A Phase 1 Safety, Tolerability and Pharmacokinetic Study of NOV-1776 Compared to Ketorolac Tromethamine IV in Adult Healthy Volunteers and Gout Patients
Query!
Secondary ID [1]
0
0
NOV-1776-CL-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Gouty Arthritis
0
0
Query!
Acute Pain
0
0
Query!
Gout Flare
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Ketorolac Tromethamine 15 MG/ML
Treatment: Drugs - Ketorolac Tromethamine
Experimental: Ketorolac tromethamine - Cohort 1 - All subjects receive one Ketorolac tromethamine injection, followed by Ketorolac tromethamine gel topical Cohort 2 and 3 - Ketorolac tromethamine gel topical
Treatment: Drugs: Ketorolac Tromethamine 15 MG/ML
Single intravenous administration of Ketorolac Tromethamine injection in Cohort 1 on day 1
Treatment: Drugs: Ketorolac Tromethamine
Three doses of topical ketorolac tromethamine over the course of 1 day, 6 hours apart for each of 3 subsequent treatment periods in cohort 1 Three doses of Ketorolac Tromethamine, 6 hours apart, over the course of 5 days in cohorts 2 and 3
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Query!
Assessment method [1]
0
0
Assessment of adverse events
Query!
Timepoint [1]
0
0
15 days
Query!
Primary outcome [2]
0
0
Area Under the Plasma Concentration Versus Time Curve (AUC) of topical ketorolac tromethamine
Query!
Assessment method [2]
0
0
Assessment of bioavailability of topical ketorolac tromethamine
Query!
Timepoint [2]
0
0
15 days
Query!
Eligibility
Key inclusion criteria
Cohorts 1 and 2
- Evidence of a personally signed and dated informed consent form (ICF) in English
- Healthy study participants who are willing and able to comply with scheduled visits,
treatment plan, laboratory tests, and other study procedures,
- Body mass index (BMI) from 18.0 to 32.0 kg/m2, inclusive; and body weight of at least
50 kg (110 lbs) and Resting supine systolic blood pressure from 90 to 140 mmHg and
supine diastolic blood pressure from 40 to 90 mmHg
- Male participants must agree to utilize a barrier contraceptive method for the
duration of the study and agree to avoid sperm donation for at least 90 days after
completing study participation and female participants must be of non-childbearing
potential (defined as either surgically sterile or at least 1 year post-menopausal;
post- menopausal is defined as no menses for 12 months and confirmed by FSH level = 40
mIU/mL); or must be using a highly effective method of contraception
Cohort 3 - additional requirements
- Medical diagnosis of gout for at least 2 years and1 - 2 acute gout flare-ups within the
last 12 months
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Cohorts 1. 2 and 3
- Presence or history of any disorder that may prevent the successful completion of
Cohort 1 [or Cohort 2, as appropriate]
- Allergy or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), ketorolac
tromethamine, or any components of the formulation and /or history of significant
allergies and hypersensitivity reactions (hives, breathing difficulty, etc.) to
aspirin or any other medications, either prescription or nonprescription, including
dietary supplements or herbal medications.
- A clinically significant history of or current abnormality or disease of any organ
system, including renal, hepatic, gastrointestinal (e.g., bleeding, ulcers,
perforation), cardiovascular (e.g., cardiovascular thrombotic events, myocardial
infarction, stroke) pulmonary (including chronic asthma), endocrine (e.g., diabetes),
central nervous system, hematologic system (e.g., bleeding disorders), psychiatric
disease, seizure, epilepsy, severe head injury, multiple sclerosis, or other known
neurological conditions, or recent surgery that the Investigator deems clinically
significant.
- History or recent occurrence of clinically significant skin disorders (including
photosensitivity reactions, eczema, and psoriasis) or any surgical or medical
condition or skin modification at the site of drug application that may interfere with
the absorption, distribution, metabolism or excretion of the test article.
- Hemoglobin < 13.2 g/dL or < 132 g/L (males) and < 11.7 g/dL or < 117 g/L (females);
Hematocrit < 38.5% (males) and < 35% (females) platelet count < 100,000 platelets per
microliter (males and females); at Screening
- Uncontrolled hypertension with consistent blood pressure higher than 140 / 90 mmHg.
- within 7 days prior to study enrollment, acute illness (e.g., nausea, vomiting, fever,
or diarrhea), use of any prescription OTC or dietary or herbal supplements, including
ketorolac tromethamine
- within 60 days prior to study enrollment, plasma or blood donation
- within 90 days prior to study enrollment, use of hepatic or renal clearance altering
agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort,
etc.)
- Positive finding on urine drug screen ( (amphetamines, barbiturates, benzodiazepines,
cannabinoids, cocaine, cotinine, methadone, and opiates or other substances deemed
inappropriate); Positive serological findings for any of the following: Human
Immunodeficiency Virus (HIV), Hepatitis B surface antigen, Hepatitis C antibody, or
Hepatitis A IgM tests at Screening.
- Female participants who are pregnant or breastfeeding.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
1/02/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2024
Query!
Actual
Query!
Sample size
Target
30
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Paratus Clinical, - Blacktown
Query!
Recruitment hospital [2]
0
0
Linear Clinical Research Ltd - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
6009 - Nedlands
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Novilla Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will be a phase 1, open-label, bioavailability, safety and PK study of topically
applied transcutaneous ketorolac tromethamine gel 12.5% (/w) (NOV-1776) versus intravenous
administration of approved ketorolac tromethamine injection, USP (15mg/mL) comparator in
healthy volunteers, including an evaluation of safety, tolerability, and efficacy in gout
participants with flare-up.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06273813
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novotech CRO
Query!
Address
0
0
Novotech
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Novotech CRO
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61 2 8569 1400
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06273813
Download to PDF