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=99 Participants
|
33.2 Years
STANDARD_DEVIATION 12.2 • n=107 Participants
|
32.0 Years
STANDARD_DEVIATION 12.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 48 hoursChange 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