A Phase 3 interventional study of placebo and Placebos in Acute Blunt Soft Tissue Injuries/Contusions, sponsored by Novartis. Completed at 10 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
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.
43 studies on the registry are indexed under Contusions; 8 are open to participants now.
This study's enrollment of 215 is above the median of 90 across 31 interventional studies indexed under Contusions.
Browse Contusions studies →Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.
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Exclusion Criteria:
diclofenac sodium gel 1%
Drug: placebo
Placebo
Drug: Placebos
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
| Milestone | Diclofenac Sodium Gel 1% | Placebo |
|---|---|---|
| Started | 109 | 106 |
| Completed | 103 | 103 |
| Not completed | 6 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Unable or unwilling to cooperate with | 2 | 0 |
| Withdrew: Lost to follow-up | 3 | 2 |
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.
| units on a scale | Diclofenac Sodium Gel 1% | Placebo |
|---|---|---|
| Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) | 42.9 ± 40.6 | 45.5 ± 42.6 |
Collected over 7 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diclofenac Sodium Gel 1% | — | 0/109 (0%) | 4/109 (3.7%) |
| Placebo | — | 0/106 (0%) | 2/106 (1.9%) |
| Event | Diclofenac Sodium Gel 1% | Placebo |
|---|---|---|
| headacheNervous system disorders | 4/109 | 2/106 |
| Age, Continuous(years) | Diclofenac Sodium Gel 1% | Placebo | Total |
|---|---|---|---|
| Mean | 27.3 ± 10.7 | 26.3 ± 8.5 | 26.8 ± 9.7 |
| Sex: Female, Male(Participants) | Diclofenac Sodium Gel 1% | Placebo | Total |
|---|---|---|---|
| Female | 17 | 24 | 41 |
| Male | 92 | 82 | 174 |
| Region of Enrollment(participants) | Diclofenac Sodium Gel 1% | Placebo | Total |
|---|---|---|---|
| United States | 109 | 106 | 215 |
The record gives a start of Dec 2014, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2017, 1 year 7 months after primary completion.
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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