Ankle Sprain
Conditions
Keywords
Ankle sprain, soft tissue injury
Brief summary
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Interventions
DRUGDiclofenac sodium topical gel 1%
Diclofenac sodium topical gel 1%, 4 times daily
DRUGPlacebo
Placebo, 4 times daily
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18 years and over. 2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. 3. Injury within past 12 hours.
Exclusion criteria
1. Pain medication was taken within the 6 hours that precede randomization. 2. During the past 3 months: Grade I-III sprain of the same ankle. 3. During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot. 4. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. 5. Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on Movement | 72 hours | Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain on Movement | 24 hours and 7 days | Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain |
| Onset of Pain Relief | Day 1 | Onset of perceptible pain relief |
| Tenderness | Change from baseline at 24 and 72 hours, 7 days | Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness. |
| Ankle Joint Function | 24 and 72 hours, 7 days | Ankle joint function score (Karlsson Scoring scale which ranges from 0 worst possible score to 90 best possible score)at 24 and 72 hours and 7 days. |
Countries
United States
Participant flow
Recruitment details
Study Start 30 Nov 2010 Study end 17 Juin 2011
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Sodium Topical Gel 1% | 104 |
| Placebo | 102 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal Laboratory value | 3 | 2 |
| Overall Study | Use of prohibited medications | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | Diclofenac Sodium Topical Gel 1% |
|---|---|---|---|
| 18 years and above <=18 years | 0 participants | 0 participants | 0 participants |
| 18 years and above 18 years and above | 206 participants | 102 participants | 104 participants |
| Age Continuous | 30.9 years STANDARD_DEVIATION 13.5 | 30.8 years STANDARD_DEVIATION 13.9 | 31.0 years STANDARD_DEVIATION 13.1 |
| Region of Enrollment United States | 206 participants | 102 participants | 104 participants |
| Sex: Female, Male Female | 119 Participants | 57 Participants | 62 Participants |
| Sex: Female, Male Male | 87 Participants | 45 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 104 | 8 / 102 |
| serious Total, serious adverse events | 0 / 104 | 0 / 102 |
Outcome results
Primary
Pain on Movement
Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Pain on Movement | 37.4 mm | Standard Deviation 25.2 |
| Placebo | Pain on Movement | 38.8 mm | Standard Deviation 24.1 |
Secondary
Ankle Joint Function
Ankle joint function score (Karlsson Scoring scale which ranges from 0 worst possible score to 90 best possible score)at 24 and 72 hours and 7 days.
Time frame: 24 and 72 hours, 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Ankle Joint Function | 24 Hours | 30.1 Total score | Standard Deviation 18.7 |
| Diclofenac Sodium Topical Gel 1% | Ankle Joint Function | 72 Hours | 47.2 Total score | Standard Deviation 19.3 |
| Diclofenac Sodium Topical Gel 1% | Ankle Joint Function | 7 days | 68.8 Total score | Standard Deviation 20 |
| Placebo | Ankle Joint Function | 7 days | 66.4 Total score | Standard Deviation 21.5 |
| Placebo | Ankle Joint Function | 24 Hours | 30.7 Total score | Standard Deviation 17.6 |
| Placebo | Ankle Joint Function | 72 Hours | 46.1 Total score | Standard Deviation 19.8 |
Secondary
Onset of Pain Relief
Onset of perceptible pain relief
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Onset of Pain Relief | 2 Hour |
| Placebo | Onset of Pain Relief | 2 Hour |
Secondary
Pain on Movement
Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= No pain and 100= Extreme pain
Time frame: 24 hours and 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Pain on Movement | 24 hours | 52.9 mm | Standard Deviation 22.5 |
| Diclofenac Sodium Topical Gel 1% | Pain on Movement | 7 days | 19.4 mm | Standard Deviation 23.1 |
| Placebo | Pain on Movement | 24 hours | 53.1 mm | Standard Deviation 22.6 |
| Placebo | Pain on Movement | 7 days | 22 mm | Standard Deviation 23.5 |
Secondary
Tenderness
Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.
Time frame: Change from baseline at 24 and 72 hours, 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Tenderness | Change from baseline at 24 Hours | 2.3 N/cm^2 | Standard Deviation 8.2 |
| Diclofenac Sodium Topical Gel 1% | Tenderness | Change from baseline at 72 Hours | 6.4 N/cm^2 | Standard Deviation 11.9 |
| Diclofenac Sodium Topical Gel 1% | Tenderness | Change from baseline at 7 Days | 12.1 N/cm^2 | Standard Deviation 13.3 |
| Placebo | Tenderness | Change from baseline at 24 Hours | 1.3 N/cm^2 | Standard Deviation 7.7 |
| Placebo | Tenderness | Change from baseline at 72 Hours | 5.5 N/cm^2 | Standard Deviation 11.4 |
| Placebo | Tenderness | Change from baseline at 7 Days | 11.9 N/cm^2 | Standard Deviation 10.6 |