Osteoarthritis
Conditions
Brief summary
The purpose of this study is to evaluate the safety of Diclofenac \[Test\] Capsules for the treatment of osteoarthritis pain of the knee or hip.
Interventions
DRUGDiclofenac
35 mg bid or tid Capsules
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
* Male or female ≥ \[greater than or equal to\] 40 years of age * If a participant in the previous DIC3-08-05 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 * Is a current chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for his/her OA pain and is anticipated to benefit from continuous treatment with therapeutic doses of NSAIDs. A current chronic user is defined as a subject who has used these treatments for ≥ \[greater than or equal to\] 20 days of the last 30 days before screening
Exclusion criteria
* Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac * Requires chronic use of opioid or opioid combination products to control OA pain of the knee or hip * Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease * Has significant difficulties swallowing capsules or is unable to tolerate oral medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Diclofenac 35 mg Capsules 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 Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | Baseline to Week 52/Early Termination | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. |
| Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | Baseline to Week 52/Early Termination | The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac 35 mg Capsules Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator. | 601 |
| Total | 601 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 99 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | Non-compliance with trial drug | 23 |
| Overall Study | Other, including joint replacement | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 27 |
| Overall Study | Withdrawal by Subject | 49 |
Baseline characteristics
| Characteristic | Diclofenac 35 mg Capsules |
|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 8.89 |
| Baseline Mental Component Score of the Short Form-36 Questionnaire | 52.0 units on a scale STANDARD_DEVIATION 9.6 |
| Baseline Physical Component Score of the Short Form-36 Questionnaire | 39.5 units on a scale STANDARD_DEVIATION 7.72 |
| Body Mass Index | 30.574 kg/m2 STANDARD_DEVIATION 4.9818 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 561 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 169.25 cm STANDARD_DEVIATION 9.898 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 participants |
| Race/Ethnicity, Customized Asian | 6 participants |
| Race/Ethnicity, Customized Black or African American | 89 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 506 participants |
| Sex: Female, Male Female | 372 Participants |
| Sex: Female, Male Male | 229 Participants |
| Weight | 87.93 kg STANDARD_DEVIATION 17.005 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 191 / 601 |
| serious Total, serious adverse events | 42 / 601 |
Outcome results
Primary
Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination
The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.
Time frame: Baseline to Week 52/Early Termination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diclofenac 35 mg Capsules | Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 TEAE | 451 participants |
| Diclofenac 35 mg Capsules | Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 severe TEAE | 41 participants |
| Diclofenac 35 mg Capsules | Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination | Subjects with at least 1 serious adverse event | 42 participants |
Other Pre-specified
Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.
Time frame: Baseline to Week 52/Early Termination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac 35 mg Capsules | Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | Mean score at Week 52/early termination (ET) | 52.3 units on a scale | Standard Deviation 9.44 |
| Diclofenac 35 mg Capsules | Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | Change from baseline to Week 52/ET | 0.1 units on a scale | Standard Deviation 8.41 |
Other Pre-specified
Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET
The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.
Time frame: Baseline to Week 52/Early Termination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac 35 mg Capsules | Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | Mean score at Week 52/early termination (ET) | 44.2 units on a scale | Standard Deviation 8.29 |
| Diclofenac 35 mg Capsules | Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET | Mean change from baseline to Week 52/ET | 4.5 units on a scale | Standard Deviation 6.89 |