Acute Blunt Soft Tissue Injuries/Contusions
Conditions
Brief summary
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.
Interventions
DRUGplacebo
DRUGPlacebos
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 16 years and over Fresh impact injury of the upper or lower limbs, not requiring admittance to hospital & meeting baseline pain intensity level Anticipated time between injury and treatment must be ≤ 6 hours
Exclusion criteria
* Pain medication prior to randomization Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated Any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) | 24 hours | The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Sodium Gel 1% diclofenac sodium gel 1%
diclofenac sodium gel 1% | 109 |
| Placebo Placebo
diclofenac sodium gel 1% | 106 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Unable or unwilling to cooperate with | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Diclofenac Sodium Gel 1% | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 27.3 years STANDARD_DEVIATION 10.7 | 26.3 years STANDARD_DEVIATION 8.5 | 26.8 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 109 participants | 106 participants | 215 participants |
| Sex: Female, Male Female | 17 Participants | 24 Participants | 41 Participants |
| Sex: Female, Male Male | 92 Participants | 82 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 109 | 2 / 106 |
| serious Total, serious adverse events | 0 / 109 | 0 / 106 |
Outcome results
Primary
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)
The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Gel 1% | Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) | 42.9 units on a scale | Standard Deviation 40.6 |
| Placebo | Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) | 45.5 units on a scale | Standard Deviation 42.6 |