Trial Outcomes & Findings for Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain (NCT NCT00573768)

NCT ID: NCT00573768

Last Updated: 2012-04-20

Results Overview

Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 271 participants
• Primary outcome timeframe: change from baseline (on day 1) to day 5
• Results posted on: 2012-04-20

Participant Flow

Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices

Participant milestones

Measure	Diclofenac Diethylamine (DDEA) 2.32% Gel BID Twice daily (BID) application	DDEA 2.32% Gel OD Once daily (OD) application of active gel and OD application of vehicle gel	Vehicle Gel BID application
Overall Study STARTED	89	91	91
Overall Study COMPLETED	87	89	87
Overall Study NOT COMPLETED	2	2	4

Reasons for withdrawal

Measure	Diclofenac Diethylamine (DDEA) 2.32% Gel BID Twice daily (BID) application	DDEA 2.32% Gel OD Once daily (OD) application of active gel and OD application of vehicle gel	Vehicle Gel BID application
Overall Study Adverse Event	1	1	2
Overall Study Protocol Violation	1	0	1
Overall Study Withdrawal by Subject	0	1	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Baseline characteristics by cohort

Measure	Diclofenac Diethylamine (DDEA) 2.32% Gel BID n=89 Participants Twice daily (BID) application	DDEA 2.32% Gel OD n=91 Participants Once daily (OD) application of active gel and OD application of vehicle gel	Vehicle Gel n=91 Participants BID application	Total n=271 Participants Total of all reporting groups
Age Continuous	38.8 years STANDARD_DEVIATION 13.7 • n=5 Participants	38.2 years STANDARD_DEVIATION 14.6 • n=7 Participants	38.9 years STANDARD_DEVIATION 14.1 • n=5 Participants	38.6 years STANDARD_DEVIATION 14.1 • n=4 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	47 Participants n=7 Participants	46 Participants n=5 Participants	142 Participants n=4 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	44 Participants n=7 Participants	45 Participants n=5 Participants	129 Participants n=4 Participants
Region of Enrollment Germany	89 participants n=5 Participants	91 participants n=7 Participants	91 participants n=5 Participants	271 participants n=4 Participants

PRIMARY outcome

Timeframe: change from baseline (on day 1) to day 5

Population: Intent to treat (ITT)

Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

Outcome measures

Measure	Diclofenac Diethylamine (DDEA) 2.32% Gel BID n=89 Participants Twice daily (BID) application	DDEA 2.32% Gel OD n=91 Participants Once daily (OD) application of active gel and OD application of vehicle gel	Vehicle Gel n=91 Participants BID application
Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.	38.3 mm Standard Deviation 22.7	35.7 mm Standard Deviation 20.4	33.4 mm Standard Deviation 20.9

Adverse Events

Diclofenac Diethylamine (DDEA) 2.32% Gel BID

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

DDEA 2.32% Gel OD

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Vehicle Gel

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 (DDEA) 2.32% Gel BID n=89 participants at risk Twice daily (BID) application	DDEA 2.32% Gel OD n=91 participants at risk Once daily (OD) application of active gel and OD application of vehicle gel	Vehicle Gel n=91 participants at risk BID application
Nervous system disorders headache	3.4% 3/89	6.6% 6/91	1.1% 1/91

Additional Information

Sandy Hamelsky

Novartis Consumer Health

Phone: +19735037258

Email: sandy.hamelsky@novartis.com

Results disclosure agreements

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