Trial Outcomes & Findings for Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries (NCT NCT01272947)

NCT ID: NCT01272947

Last Updated: 2013-01-10

Results Overview

Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 204 participants
• Primary outcome timeframe: VAS Score at 24 hours
• Results posted on: 2013-01-10

Participant Flow

Participant milestones

Measure	Diclofenac Sodium Topical Gel 1%	Placebo
Overall Study STARTED	104	100
Overall Study COMPLETED	102	98
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Diclofenac Sodium Topical Gel 1%	Placebo
Overall Study Abnormal Laboratory Value	2	2

Baseline Characteristics

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

Baseline characteristics by cohort

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=100 Participants	Total n=204 Participants Total of all reporting groups
Age Continuous Unit : years	29.4 years STANDARD_DEVIATION 9.6 • n=93 Participants	31.4 years STANDARD_DEVIATION 12.1 • n=4 Participants	30.4 years STANDARD_DEVIATION 10.9 • n=27 Participants
Sex: Female, Male Female	55 Participants n=93 Participants	48 Participants n=4 Participants	103 Participants n=27 Participants
Sex: Female, Male Male	49 Participants n=93 Participants	52 Participants n=4 Participants	101 Participants n=27 Participants
Region of Enrollment Germany	104 participants n=93 Participants	100 participants n=4 Participants	204 participants n=27 Participants

PRIMARY outcome

Timeframe: 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"

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=100 Participants
Pain on Movement	33.1 mm Standard Deviation 21.4	65.4 mm Standard Deviation 16.9

SECONDARY outcome

Timeframe: From randomization to end of day 1

Onset of perceptible pain relief.

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=100 Participants
Onset of Pain Relief	2 Hours Interval 1.0 to 4.0	NA Hours Interval 4.9 to The median time was not reached in the placebo group.

Adverse Events

Diclofenac Sodium Topical Gel 1%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diclofenac Sodium Topical Gel 1% n=104 participants at risk	Placebo n=100 participants at risk
Infections and infestations Infections and Infestations	1.9% 2/104 • Number of events 2	3.0% 3/100 • Number of events 3
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	0.00% 0/104	1.0% 1/100 • Number of events 1

Additional Information

Clinical Project Leader

Novartis Consumer Health S.A.

Phone: +41 22 3635528

Results disclosure agreements

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

Restriction type: OTHER