Trial Outcomes & Findings for Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain (NCT NCT01666197)

NCT ID: NCT01666197

Last Updated: 2014-04-17

Results Overview

Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2014-04-17

Participant Flow

Four centers in Germany recruited patients from 22 Aug 2012 to 27 Jan 2013

Participant milestones

Measure	Diclofenac Potassium 25 mg Tablet diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet	Placebo placebo: placebo
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

Baseline characteristics by cohort

Measure	Diclofenac Potassium 25 mg Tablet n=50 Participants diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet	Placebo n=50 Participants placebo: placebo	Total n=100 Participants Total of all reporting groups
Age, Continuous	30.7 Years STANDARD_DEVIATION 13.4 • n=5 Participants	33.2 Years STANDARD_DEVIATION 12.2 • n=7 Participants	32.0 Years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"

Outcome measures

Measure	Diclofenac Potassium 25 mg Tablet n=50 Participants diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet	Placebo n=50 Participants placebo: placebo
Pain on Movement	31.3 mm Standard Deviation 18.8	59.2 mm Standard Deviation 12.8

Adverse Events

Diclofenac Potassium 25 mg Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diclofenac Potassium 25 mg Tablet n=50 participants at risk diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet	Placebo n=50 participants at risk placebo: placebo
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.0% 1/50 • Number of events 1	0.00% 0/50
General disorders Feeling hot	0.00% 0/50	2.0% 1/50 • Number of events 1
Nervous system disorders Headache	0.00% 0/50	4.0% 2/50 • Number of events 2

Additional Information

Clinical Project Leader

Novartis Consumer Health SA

Phone: 41223635293

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