Trial Outcomes & Findings for Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain (NCT NCT01255423)

NCT ID: NCT01255423

Last Updated: 2012-10-04

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: 206 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2012-10-04

Participant Flow

Study Start 30 Nov 2010 Study end 17 Juin 2011

Participant milestones

Measure	Diclofenac Sodium Topical Gel 1%	Placebo
Overall Study STARTED	104	102
Overall Study COMPLETED	101	99
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Diclofenac Sodium Topical Gel 1%	Placebo
Overall Study Abnormal Laboratory value	3	2
Overall Study Use of prohibited medications	0	1

Baseline Characteristics

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

Baseline characteristics by cohort

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=102 Participants	Total n=206 Participants Total of all reporting groups
Age Continuous	31.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	30.8 years STANDARD_DEVIATION 13.9 • n=7 Participants	30.9 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	57 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	45 Participants n=7 Participants	87 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants	102 participants n=7 Participants	206 participants n=5 Participants
18 years and above <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
18 years and above 18 years and above	104 participants n=5 Participants	102 participants n=7 Participants	206 participants n=5 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=104 Participants	Placebo n=102 Participants
Pain on Movement	37.4 mm Standard Deviation 25.2	38.8 mm Standard Deviation 24.1

SECONDARY outcome

Timeframe: 24 hours and 7 days

Pain on movement at 24 hours and 7 days 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=104 Participants	Placebo n=102 Participants
Pain on Movement 24 hours	52.9 mm Standard Deviation 22.5	53.1 mm Standard Deviation 22.6
Pain on Movement 7 days	19.4 mm Standard Deviation 23.1	22 mm Standard Deviation 23.5

SECONDARY outcome

Timeframe: Day 1

Onset of perceptible pain relief

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=102 Participants
Onset of Pain Relief	2 Hour Interval 2.0 to 2.2	2 Hour Interval 1.8 to 6.0

SECONDARY outcome

Timeframe: Change from baseline at 24 and 72 hours, 7 days

Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=102 Participants
Tenderness Change from baseline at 24 Hours	2.3 N/cm^2 Standard Deviation 8.2	1.3 N/cm^2 Standard Deviation 7.7
Tenderness Change from baseline at 72 Hours	6.4 N/cm^2 Standard Deviation 11.9	5.5 N/cm^2 Standard Deviation 11.4
Tenderness Change from baseline at 7 Days	12.1 N/cm^2 Standard Deviation 13.3	11.9 N/cm^2 Standard Deviation 10.6

SECONDARY outcome

Timeframe: 24 and 72 hours, 7 days

Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days.

Outcome measures

Measure	Diclofenac Sodium Topical Gel 1% n=104 Participants	Placebo n=102 Participants
Ankle Joint Function 7 days	68.8 Total score Standard Deviation 20.0	66.4 Total score Standard Deviation 21.5
Ankle Joint Function 24 Hours	30.1 Total score Standard Deviation 18.7	30.7 Total score Standard Deviation 17.6
Ankle Joint Function 72 Hours	47.2 Total score Standard Deviation 19.3	46.1 Total score Standard Deviation 19.8

Adverse Events

Diclofenac Sodium Topical Gel 1%

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 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=102 participants at risk
Nervous system disorders Nervous Sytem disorders	4.8% 5/104 • Number of events 5	2.9% 3/102 • Number of events 3
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	1.9% 2/104 • Number of events 2	2.9% 3/102 • Number of events 3
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.96% 1/104 • Number of events 1	2.9% 3/102 • Number of events 3
Infections and infestations Infection and infestations	1.9% 2/104 • Number of events 2	0.00% 0/102
General disorders General disorders and administration site conditions	0.96% 1/104 • Number of events 1	0.98% 1/102 • Number of events 1
Hepatobiliary disorders Hepatobiliary disorders	0.96% 1/104 • Number of events 1	0.00% 0/102
Injury, poisoning and procedural complications Injury poisoning and procedural complications	0.00% 0/104	0.98% 1/102 • Number of events 1
Renal and urinary disorders Renal and urinary disorders	0.00% 0/104	0.98% 1/102 • Number of events 1
Reproductive system and breast disorders Reproductive system and breast disorders	0.96% 1/104 • Number of events 1	0.00% 0/102
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.96% 1/104 • Number of events 1	0.00% 0/102

Additional Information

Clinical Project Leader

Novartis Consumer Health

Phone: 0041223635528

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