Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Osteoarthritis Clinical Trial

Official title:

A Phase 2b, Multicenter, Randomized, Single Blind, Fixed Dose, Parallel Group Study to Evaluate the Efficacy and Safety of Meloxicam SoluMatrix® [Test] Capsules and Meloxicam Tablets in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02405793
• Other study ID #: MEL2-14-05
• Status: Withdrawn
• Phase: Phase 2
• First received: March 27, 2015
• Last updated: July 8, 2015
• Start date: May 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Iroko Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Meloxicam Test Capsules

• Meloxicam Test Capsules

• Meloxicam Tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iroko Pharmaceuticals, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Patient Global Impression of Change		Baseline to Week 6/Early Termination	No
Secondary	Clinical Global Impression of Change		Baseline to Week 6/Early Termination	No
Secondary	Amount of Rescue Medication Taken by Each Subject		Baseline to Week 6/Early Termination	No
Secondary	Cumulative Discontinuations Due to Lack of Efficacy at Week 6		Baseline to Week 6	No
Secondary	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	No
Secondary	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	Yes