Acute Ankle Sprain
Conditions
Keywords
Ankle Sprain, soft tissue injury
Brief summary
The purpose of this study is to evaluate the efficacy of 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%-4 times daily
OTHERPlacebo
Topical gel-4 times daily
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours.
Exclusion criteria
* Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.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.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.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).
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 |
|---|---|---|
| Onset of Pain Relief | On day 1 | Onset of perceptible pain relief. |
Countries
Germany
Participant flow
Recruitment details
Study Start 18 January 2011 Study end 23 August 2011
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Sodium Topical Gel 1% Diclofenac sodium topical gel 1%
Diclofenac Sodium : Topical gel 1%-4 times daily | 102 |
| Placebo Placebo : Topical gel-4 times daily | 103 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal Laboratory Value | 0 | 1 |
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Diclofenac Sodium Topical Gel 1% | Placebo | Total |
|---|---|---|---|
| Age Continuous | 32.5 years STANDARD_DEVIATION 12 | 30.5 years STANDARD_DEVIATION 10.8 | 31.5 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment Germany | 102 participants | 103 participants | 205 participants |
| Sex: Female, Male Female | 49 Participants | 55 Participants | 104 Participants |
| Sex: Female, Male Male | 53 Participants | 48 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 102 | 3 / 103 |
| serious Total, serious adverse events | 0 / 102 | 1 / 103 |
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 | 25.6 mm | Standard Deviation 15.9 |
| Placebo | Pain on Movement | 61.2 mm | Standard Deviation 16.6 |
Secondary
Onset of Pain Relief
Onset of perceptible pain relief.
Time frame: On day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Onset of Pain Relief | 4 Hours |
| Placebo | Onset of Pain Relief | NA Hours |