Ankle Sprain
Conditions
Keywords
Acute Joint Pain
Brief summary
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Interventions
DRUGdiclofenac potassium 25 mg tablet
diclofenac potassium 25 mg tablet
DRUGplacebo
placebo
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 | 48 hours | Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain |
Countries
Germany
Participant flow
Recruitment details
Four centers in Germany recruited patients from 22 Aug 2012 to 27 Jan 2013
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Potassium 25 mg Tablet diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet | 50 |
| Placebo placebo: placebo | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Diclofenac Potassium 25 mg Tablet | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 30.7 Years STANDARD_DEVIATION 13.4 | 32.0 Years STANDARD_DEVIATION 12.9 | 33.2 Years STANDARD_DEVIATION 12.2 |
| 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 | 0 Participants | 0 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 | 50 Participants | 100 Participants | 50 Participants |
| Region of Enrollment Germany | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 23 Participants | 47 Participants | 24 Participants |
| Sex: Female, Male Male | 27 Participants | 53 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 50 | 3 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Pain on Movement
Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Potassium 25 mg Tablet | Pain on Movement | 31.3 mm | Standard Deviation 18.8 |
| Placebo | Pain on Movement | 59.2 mm | Standard Deviation 12.8 |