Trial Outcomes & Findings for Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain (NCT NCT01272934)

NCT ID: NCT01272934

Last Updated: 2013-01-24

Results Overview

Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 205 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2013-01-24

Participant Flow

Study Start 18 January 2011 Study end 23 August 2011

Participant milestones

Measure	Diclofenac Sodium Topical Gel 1% Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo Placebo : Topical gel-4 times daily
Overall Study STARTED	102	103
Overall Study COMPLETED	102	101
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Diclofenac Sodium Topical Gel 1% Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo Placebo : Topical gel-4 times daily
Overall Study Adverse Event	0	1
Overall Study Abnormal Laboratory Value	0	1

Baseline Characteristics

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

Baseline characteristics by cohort

Measure	Total n=205 Participants Total of all reporting groups	Diclofenac Sodium Topical Gel 1% n=102 Participants Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo n=103 Participants Placebo : Topical gel-4 times daily
Age Continuous	31.5 years STANDARD_DEVIATION 11.4 • n=5 Participants	32.5 years STANDARD_DEVIATION 12.0 • n=5 Participants	30.5 years STANDARD_DEVIATION 10.8 • n=7 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	49 Participants n=5 Participants	55 Participants n=7 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	53 Participants n=5 Participants	48 Participants n=7 Participants
Region of Enrollment Germany	205 participants n=5 Participants	102 participants n=5 Participants	103 participants n=7 Participants

PRIMARY outcome

Timeframe: 72 hours

Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=102 Participants Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo n=103 Participants Placebo : Topical gel-4 times daily
Pain on Movement	25.6 mm Standard Deviation 15.9	61.2 mm Standard Deviation 16.6

SECONDARY outcome

Timeframe: On day 1

Onset of perceptible pain relief.

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=102 Participants Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo n=103 Participants Placebo : Topical gel-4 times daily
Onset of Pain Relief	4 Hours Interval 2.0 to 6.0	NA Hours Onset of Pain relief was not achieved for the first quartile within the given time frame in the placebo group

Adverse Events

Diclofenac Sodium Topical Gel 1%

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Diclofenac Sodium Topical Gel 1% n=102 participants at risk Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo n=103 participants at risk Placebo : Topical gel-4 times daily
Injury, poisoning and procedural complications Distorsion of wrist and ligament rupture	0.00% 0/102	0.97% 1/103 • Number of events 1

Other adverse events

Measure	Diclofenac Sodium Topical Gel 1% n=102 participants at risk Diclofenac sodium topical gel 1% Diclofenac Sodium : Topical gel 1%-4 times daily	Placebo n=103 participants at risk Placebo : Topical gel-4 times daily
Infections and infestations Infections and infestations	2.9% 3/102 • Number of events 3	1.9% 2/103 • Number of events 2
Gastrointestinal disorders Gastrointestinal disorders	0.98% 1/102 • Number of events 1	0.00% 0/103
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/102	0.97% 1/103 • Number of events 1
Nervous system disorders Nervous system disorders	0.98% 1/102 • Number of events 1	0.00% 0/103
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.98% 1/102 • Number of events 1	0.00% 0/103

Additional Information

Clinical Project Leader

Novartis Consumer Health

Phone: 0041223635228

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