Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Phase 2

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Drug: Meloxicam Tablets; Drug: Meloxicam Test Capsules

• Registration Number: NCT02405793
• Lead Sponsor: Iroko Pharmaceuticals, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-04-01
• Study Start: 2015-05
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-08
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meloxicam tablets	Meloxicam Tablets	Meloxicam Tablets QD
Meloxicam high dose test capsule	Meloxicam Test Capsules	Meloxicam SoluMatrix Capsules - high dose QD
Meloxicam low dose test capsule	Meloxicam Test Capsules	Meloxicam SoluMatrix Capsules - low dose QD

Primary Outcome Measures

Name	Time	Method
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.	Baseline to Week 6

Secondary Outcome Measures

Name	Time	Method
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.	Baseline to Week 6
Amount of Rescue Medication Taken by Each Subject	Baseline to Week 6/Early Termination
Cumulative Discontinuations Due to Lack of Efficacy at Week 6	Baseline to Week 6
Responders with at Least a 10-mm Improvement in Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 6.	Baseline to Week 6
Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 3.	2 hours after dosing on Day 3
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.	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.	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.	2 hours after dosing on Day 14
Patient Global Impression of Change	Baseline to Week 6/Early Termination
Clinical Global Impression of Change	Baseline to Week 6/Early Termination
Safety of Meloxicam SoluMatrix Capsules low dose, Meloxicam SoluMatrix Capsules high dose, and Meloxicam Tablets as Assessed by the Incidence of Adverse Events From Baseline to Week 6 or Early Termination	Baseline to Week 6/Early Termination
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.	Baseline to Week 6
Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 14.	2 hours after dosing on Day 14