Trial Outcomes & Findings for Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries (NCT NCT02290821)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

215 participants

Primary outcome timeframe

24 hours

Results posted on

2017-04-19

Participant Flow

Participant milestones

Participant milestones
Measure	Diclofenac Sodium Gel 1% diclofenac sodium gel 1% diclofenac sodium gel 1%	Placebo Placebo diclofenac sodium gel 1%
Overall Study STARTED	109	106
Overall Study COMPLETED	103	103
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Diclofenac Sodium Gel 1% diclofenac sodium gel 1% diclofenac sodium gel 1%	Placebo Placebo diclofenac sodium gel 1%
Overall Study Withdrawal by Subject	1	1
Overall Study Unable or unwilling to cooperate with	2	0
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac Sodium Gel 1% n=109 Participants diclofenac sodium gel 1% diclofenac sodium gel 1%	Placebo n=106 Participants Placebo diclofenac sodium gel 1%	Total n=215 Participants Total of all reporting groups
Age, Continuous	27.3 years STANDARD_DEVIATION 10.7 • n=99 Participants	26.3 years STANDARD_DEVIATION 8.5 • n=107 Participants	26.8 years STANDARD_DEVIATION 9.7 • n=206 Participants
Sex: Female, Male Female	17 Participants n=99 Participants	24 Participants n=107 Participants	41 Participants n=206 Participants
Sex: Female, Male Male	92 Participants n=99 Participants	82 Participants n=107 Participants	174 Participants n=206 Participants
Region of Enrollment United States	109 participants n=99 Participants	106 participants n=107 Participants	215 participants n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Gel 1% n=109 Participants diclofenac sodium gel 1% diclofenac sodium gel 1%	Placebo n=106 Participants Placebo 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	45.5 units on a scale Standard Deviation 42.6

Adverse Events

Diclofenac Sodium Gel 1%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diclofenac Sodium Gel 1% n=109 participants at risk diclofenac sodium gel 1% diclofenac sodium gel 1%	Placebo n=106 participants at risk Placebo diclofenac sodium gel 1%
Nervous system disorders headache	3.7% 4/109 • Number of events 4 • 7 days	1.9% 2/106 • Number of events 2 • 7 days

Additional Information

Clinical Research Director Pain, CH Clinical Research & Development Lead

Novartis Consumer Health

Phone: +41225672574

Results disclosure agreements

Principal investigator is a sponsor employee Preliminary agreement between Novartis Consumer Health and the investigator
Publication restrictions are in place

Restriction type: OTHER