Trial Outcomes & Findings for Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain (NCT NCT00955513)

NCT ID: NCT00955513

Last Updated: 2012-04-20

Results Overview

Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 242 participants
• Primary outcome timeframe: baseline and day 5
• Results posted on: 2012-04-20

Participant Flow

6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009.

Participant milestones

Measure	Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day drug	Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day drug	Placebo. Applied 3 Times a Day. placebo
Overall Study STARTED	80	80	82
Overall Study COMPLETED	79	78	79
Overall Study NOT COMPLETED	1	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Baseline characteristics by cohort

Measure	Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day n=80 Participants drug	Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day n=80 Participants drug	Placebo. Applied 3 Times a Day. n=82 Participants placebo	Total n=242 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	77 Participants n=7 Participants	81 Participants n=5 Participants	238 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age Continuous	30.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	32.2 years STANDARD_DEVIATION 13.7 • n=7 Participants	34.0 years STANDARD_DEVIATION 12.9 • n=5 Participants	32.4 years STANDARD_DEVIATION 12.7 • n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	31 Participants n=7 Participants	28 Participants n=5 Participants	90 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	49 Participants n=7 Participants	54 Participants n=5 Participants	152 Participants n=4 Participants
Region of Enrollment Germany	80 participants n=5 Participants	80 participants n=7 Participants	82 participants n=5 Participants	242 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and day 5

Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.

Outcome measures

Measure	Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day n=80 Participants drug	Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day n=80 Participants drug	Placebo. Applied 3 Times a Day. n=82 Participants placebo
Measure: Pain on Movement on Day 5 (Change From Baseline).	49.1 mm Standard Deviation 19.3	49.7 mm Standard Deviation 21.5	25.4 mm Standard Deviation 14.8

Adverse Events

Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo. Applied 3 Times a Day.

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day n=80 participants at risk drug	Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day n=80 participants at risk drug	Placebo. Applied 3 Times a Day. n=82 participants at risk placebo
Nervous system disorders Headache	0.00% 0/80	1.2% 1/80 • Number of events 1	1.2% 1/82 • Number of events 1

Additional Information

Clinical Project Leader Pain category

Novartis Consumer Health

Phone: +41223635528

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place