Osteoarthritis, Knee
Conditions
Keywords
Symptomatic knee OA Kellgren-Lawrence grade 1-3
Brief summary
This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).
Interventions
DRUGdiclofenac diethylamine, DDEA 2.32% gel
DRUGPlacebo
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 5. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study
Exclusion criteria
\- 1. Partial or total replacement of either knee joint, past or planned/expected during study duration. 2\. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician; 4. Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure: Pain On Movement (POM) | 2 weeks | POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain. |
Countries
Germany
Participant flow
Recruitment details
Start date 04 Oct 2013 end date 05 May 2014
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Diethylamine, DDEA 2.32% Gel diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel | 153 |
| Placebo Vehicle control | 151 |
| Total | 304 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Non Compliance | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Diclofenac Diethylamine, DDEA 2.32% Gel | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 7.8 | 64.6 years STANDARD_DEVIATION 8.1 | 65.1 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 258 Participants | 127 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 22 Participants | 46 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 153 Participants | 303 Participants | 150 Participants |
| Region of Enrollment Germany | 153 participants | 304 participants | 151 participants |
| Sex: Female, Male Female | 97 Participants | 196 Participants | 99 Participants |
| Sex: Female, Male Male | 56 Participants | 108 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 48 / 153 | 47 / 151 |
| serious Total, serious adverse events | 0 / 153 | 0 / 151 |
Outcome results
Primary
Measure: Pain On Movement (POM)
POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.
Time frame: 2 weeks
Population: The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Diethylamine, DDEA 2.32% Gel | Measure: Pain On Movement (POM) | 42.9 units on a scale | Standard Deviation 23.8 |
| Placebo | Measure: Pain On Movement (POM) | 42.1 units on a scale | Standard Deviation 23.5 |