Trial Outcomes & Findings for Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain (NCT NCT01335724)

NCT ID: NCT01335724

Last Updated: 2012-07-18

Results Overview

Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: 48 h
• Results posted on: 2012-07-18

Participant Flow

Participant milestones

Measure	Diclofenac Diethylamine 1.16% Gel	Placebo Gel
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

Baseline characteristics by cohort

Measure	Diclofenac Diethylamine 1.16% Gel n=36 Participants	Placebo Gel n=36 Participants	Total n=72 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
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	29.8 years STANDARD_DEVIATION 10.5 • n=5 Participants	37.8 years STANDARD_DEVIATION 15.2 • n=7 Participants	33.8 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Germany	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 h

Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

Outcome measures

Measure	Diclofenac Diethylamine 1.16% Gel n=36 Participants	Placebo Gel n=36 Participants
Pain on Movement	19.5 mm Standard Deviation 12.9	56.9 mm Standard Deviation 16.1

SECONDARY outcome

Timeframe: 96h

Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm "no pain". Maximum score =100 mm "extreme pain".

Outcome measures

Measure	Diclofenac Diethylamine 1.16% Gel n=36 Participants	Placebo Gel n=36 Participants
Pain at Rest	1.2 mm Standard Deviation 2.9	19.2 mm Standard Deviation 11.9

SECONDARY outcome

Timeframe: 96h

Neck Disability Index total score. Minimum = 0 "Best". Maximum = 50 "Worst"

Outcome measures

Measure	Diclofenac Diethylamine 1.16% Gel n=36 Participants	Placebo Gel n=36 Participants
Neck Disability Index	2.8 Total Score Standard Deviation 3.0	14.6 Total Score Standard Deviation 6.8

Adverse Events

Diclofenac Diethylamine 1.16% Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo 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 1.16% Gel n=36 participants at risk	Placebo Gel n=36 participants at risk
Nervous system disorders Headache	0.00% 0/36	2.8% 1/36 • Number of events 1

Additional Information

Clinical project Leader

Novartis Consumer Health

Phone: +41223635528

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