Acute Blunt Soft Tissue Injuries/Contusions
Conditions
Keywords
Blunt soft tissue injury/contusion
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 blunt soft tissue injuries/contusions of the limbs
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. * Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.
Exclusion criteria
* Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on Movement | VAS Score at 24 hours | Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Pain Relief | From randomization to end of day 1 | Onset of perceptible pain relief. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Sodium Topical Gel 1% | 104 |
| Placebo | 100 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Abnormal Laboratory Value | 2 | 2 |
Baseline characteristics
| Characteristic | Diclofenac Sodium Topical Gel 1% | Placebo | Total |
|---|---|---|---|
| Age Continuous Unit : years | 29.4 years STANDARD_DEVIATION 9.6 | 31.4 years STANDARD_DEVIATION 12.1 | 30.4 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment Germany | 104 participants | 100 participants | 204 participants |
| Sex: Female, Male Female | 55 Participants | 48 Participants | 103 Participants |
| Sex: Female, Male Male | 49 Participants | 52 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 | 2 / 104 | 4 / 100 |
| serious Total, serious adverse events | 0 / 104 | 0 / 100 |
Outcome results
Primary
Pain on Movement
Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= No pain and 100= Extreme pain
Time frame: VAS Score at 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Pain on Movement | 33.1 mm | Standard Deviation 21.4 |
| Placebo | Pain on Movement | 65.4 mm | Standard Deviation 16.9 |
Secondary
Onset of Pain Relief
Onset of perceptible pain relief.
Time frame: From randomization to end of day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diclofenac Sodium Topical Gel 1% | Onset of Pain Relief | 2 Hours |
| Placebo | Onset of Pain Relief | NA Hours |