Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Iroko Pharmaceuticals, LLC

Overview

The purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due to osteoarthritis of the knee or hip.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Osteoarthritis

Interventions

Meloxicam Test CapsulesDRUG

Meloxicam TabletsDRUG

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee * Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain * Discontinued all analgesic therapy at Screening * For women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control * Ability to ambulate Exclusion Criteria: * History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam * Requires regular (more than 2 doses per week) use of opioid or opioid combination products to control OA pain of the knee or hip * Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease * Significant difficulties swallowing capsules/tablets or unable to tolerate oral medication * Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening

Outcomes

Primary Outcomes

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.

Time frame: Baseline to Week 6

Secondary Outcomes

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.

Time frame: Baseline to Week 6

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.

Time frame: Baseline to Week 6

Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Symptoms Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.

Time frame: Baseline to Week 6

Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3.

Time frame: 2 hours after dosing on Day 3

Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14.

Time frame: 2 hours after dosing on Day 14

Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 3.

Time frame: 2 hours after dosing on Day 3

Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 14.

Data from ClinicalTrials.gov

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