Osteoarthritis
Conditions
Brief 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
Interventions
Sponsors
Iroko Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Baseline to Week 52/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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meloxicam 10 mg Participants were administered Meloxicam 10 mg once daily for up to 52 weeks. | 600 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 79 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 28 |
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Non-compliance with Trial Drug | 13 |
| Overall Study | Other, including site closure | 19 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 25 |
| Overall Study | Withdrawal by Subject | 27 |
Baseline characteristics
| Characteristic | Meloxicam 10 mg |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 8.68 |
| Body Mass Index | 30.65 kg/m^2 STANDARD_DEVIATION 5.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 567 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 169.56 cm STANDARD_DEVIATION 10.17 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 participants |
| Race/Ethnicity, Customized Asian | 6 participants |
| Race/Ethnicity, Customized Black or African-American | 73 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized White | 520 participants |
| Sex: Female, Male Female | 358 Participants |
| Sex: Female, Male Male | 242 Participants |
| Weight | 88.50 kg STANDARD_DEVIATION 18.28 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 65 / 600 |
| serious Total, serious adverse events | 35 / 600 |
Outcome results
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.
Time frame: Baseline to Week 52/Early Termination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meloxicam 10 mg | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 TEAE | 406 participants |
| Meloxicam 10 mg | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 severe TEAE | 23 participants |
| Meloxicam 10 mg | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 serious adverse event | 35 participants |
| Meloxicam 10 mg | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 treatment-related TEAE | 127 participants |
| Meloxicam 10 mg | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with AEs leading to discontinuation | 79 participants |
| Meloxicam 10 mg | Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects who died | 2 participants |