Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis
Brief summary
The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.
Detailed description
The purpose of this proposed study is to conduct a trial with knee OA patients using the diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. The neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA, are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. The results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee OA pain.
Interventions
DRUGDiclofenac Gel
Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Sponsors
Endo Pharmaceuticals
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages 20-75 * Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically. * Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.
Exclusion criteria
* Patients with clinical history of anterior cruciate ligament (ACL) involvement. * Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications) * History of ulcers or gastrointestinal (GI) bleeding * Coagulation disorders * Hypersensitivity to Aspirin or NSAIDS * Congestive Heart Failure and Edema * Advanced renal disease * Aspirin triad * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Pain Score During Week 1 | Baseline and Week 1 | Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement. |
| Percent Change From Baseline in Pain Score During Week 2 | Baseline and Week 2 | Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Gel Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Electronic Diary Too Cumbersome to Use | 2 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Reason Not Specified | 9 |
Baseline characteristics
| Characteristic | Diclofenac Gel |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Percent Change From Baseline in Pain Score During Week 1
Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.
Time frame: Baseline and Week 1
Population: Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Gel | Percent Change From Baseline in Pain Score During Week 1 | 33.3 percent change | Standard Deviation 23.7 |
Primary
Percent Change From Baseline in Pain Score During Week 2
Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.
Time frame: Baseline and Week 2
Population: Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Gel | Percent Change From Baseline in Pain Score During Week 2 | 33.3 percent change | Standard Deviation 23.7 |