Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

Osteoarthritis Clinical Trial

Official title:

A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801735
• Other study ID #: MEL3-12-03
• Status: Completed
• Phase: Phase 3
• First received: February 21, 2013
• Last updated: April 24, 2015
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: April 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 of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Is male or female = 40 years of age

• If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety

• Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain

• Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain

• If female and of childbearing potential, is nonlactating and nonpregnant

Exclusion Criteria:

• History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam

• Requires continuous 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 or unable to tolerate oral medication

• Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Meloxicam Test Capsules

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iroko Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination	The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.	Baseline to Week 52/Early Termination	Yes