Muscle Soreness
Conditions
Brief summary
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS
Interventions
Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
DRUGPlacebo
Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 18-35 years * Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening * Willing to refrain from use of ice, heat and massage during the study * DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale
Exclusion criteria
* Pain medication & corticosteroids prior to randomization * Topical analgesic or anti-inflammatory treatment over the previous month * Body mass index of \>32 kg/m2 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. | 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 modified ITT population. SPID 24 derived from Pain on Walking (POW) 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW. | 48 hours | Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome. Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 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. |
Countries
United States
Participant flow
Recruitment details
Study Start 7 Oct 2014 and End 24 dec 2014
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Sodium Gel 1% diclofenac sodium gel 1% applied four times daily
Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily | 86 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Unable or unwilling to cooperate with st | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Diclofenac Sodium Gel 1% |
|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 4.5 |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.
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 modified ITT population. SPID 24 derived from Pain on Walking (POW) 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.
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), Derived From POW. | 50.15 units on a scale (NRS) | Standard Deviation 35.95 |
| Placebo | Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. | 54.83 units on a scale (NRS) | Standard Deviation 37.04 |
Secondary
Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.
Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome. Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 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.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Gel 1% | Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW. | 151.8 units on a scale (NRS) | Standard Deviation 81.9 |
| Placebo | Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW. | 160.84 units on a scale (NRS) | Standard Deviation 83.15 |