Treatment of Topical Ketorolac Gel in Acute Gouty Flare

Launched by NOVILLA PHARMACEUTICALS · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new topical gel called ketorolac tromethamine, which is applied to the skin, to see if it can help relieve pain during acute gout flare-ups. Gout is a type of arthritis that causes sudden, severe pain and swelling in the joints. The trial will compare this gel to an approved injectable version of ketorolac to understand how safe and effective it is for treating gout pain.

To participate in the trial, you need to be a healthy adult aged 18 to 65 who can commit to attending study visits and following the treatment plan. If you have been diagnosed with gout and have experienced flare-ups in the past year, you may also be eligible. Participants will be closely monitored for their safety and how well the treatment works. It's important to note that the trial is not yet recruiting, so you will need to wait until it starts before applying.

Gender

ALL

Eligibility criteria

• 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
• 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.