Ankle Sprain
Conditions
Keywords
Ankle, sprain, diclofenac diethylamine
Brief summary
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
Interventions
Diclofenac diethylamine 2.32% gel twice daily
DRUGPlacebo
Vehicle 2 times daily
DRUGDiclofenac diethylamine 2.32% gel / Placebo
Diclofenac diethylamine 2.32% gel once daily / Vehicle once 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 75 Years
Healthy volunteers
No
Inclusion criteria
* Acute sprain of the ankle * Injury within past 48 hours.
Exclusion criteria
* Pain medication taken since the injury * Pain or instability in the same ankle due to previous ankle sprain or any other trauma. * Ankle sprain due to a known disease affecting the ligaments Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | change from baseline (on day 1) to day 5 | Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain) |
Countries
Germany
Participant flow
Recruitment details
Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Diethylamine (DDEA) 2.32% Gel BID Twice daily (BID) application | 89 |
| DDEA 2.32% Gel OD Once daily (OD) application of active gel and OD application of vehicle gel | 91 |
| Vehicle Gel BID application | 91 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Diclofenac Diethylamine (DDEA) 2.32% Gel BID | DDEA 2.32% Gel OD | Vehicle Gel | Total |
|---|---|---|---|---|
| Age Continuous | 38.8 years STANDARD_DEVIATION 13.7 | 38.2 years STANDARD_DEVIATION 14.6 | 38.9 years STANDARD_DEVIATION 14.1 | 38.6 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment Germany | 89 participants | 91 participants | 91 participants | 271 participants |
| Sex: Female, Male Female | 49 Participants | 47 Participants | 46 Participants | 142 Participants |
| Sex: Female, Male Male | 40 Participants | 44 Participants | 45 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 89 | 6 / 91 | 1 / 91 |
| serious Total, serious adverse events | 0 / 89 | 0 / 91 | 0 / 91 |
Outcome results
Primary
Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)
Time frame: change from baseline (on day 1) to day 5
Population: Intent to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Diethylamine (DDEA) 2.32% Gel BID | Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | 38.3 mm | Standard Deviation 22.7 |
| DDEA 2.32% Gel OD | Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | 35.7 mm | Standard Deviation 20.4 |
| Vehicle Gel | Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. | 33.4 mm | Standard Deviation 20.9 |