Trial Outcomes & Findings for Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA) (NCT NCT01967550)
NCT ID: NCT01967550
Last Updated: 2015-06-03
Results Overview
POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
2 weeks
Results posted on
2015-06-03
Participant Flow
Start date 04 Oct 2013 end date 05 May 2014
Participant milestones
| Measure |
Diclofenac Diethylamine, DDEA 2.32% Gel
diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel
|
Placebo
Vehicle control
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
151
|
|
Overall Study
COMPLETED
|
148
|
149
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Diclofenac Diethylamine, DDEA 2.32% Gel
diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel
|
Placebo
Vehicle control
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Non Compliance
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)
Baseline characteristics by cohort
| Measure |
Diclofenac Diethylamine, DDEA 2.32% Gel
n=153 Participants
diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel
|
Placebo
n=151 Participants
Vehicle control
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
65.1 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
64.6 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=93 Participants
|
99 Participants
n=4 Participants
|
196 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=93 Participants
|
127 Participants
n=4 Participants
|
258 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=93 Participants
|
150 Participants
n=4 Participants
|
303 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
153 participants
n=93 Participants
|
151 participants
n=4 Participants
|
304 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.
POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.
Outcome measures
| Measure |
Diclofenac Diethylamine, DDEA 2.32% Gel
n=141 Participants
diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel
|
Placebo
n=141 Participants
Vehicle control
|
|---|---|---|
|
Measure: Pain On Movement (POM)
|
42.9 units on a scale
Standard Deviation 23.8
|
42.1 units on a scale
Standard Deviation 23.5
|
Adverse Events
Diclofenac Diethylamine, DDEA 2.32% Gel
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diclofenac Diethylamine, DDEA 2.32% Gel
n=153 participants at risk
diclofenac diethylamine, DDEA 2.32% gel
diclofenac diethylamine, DDEA 2.32% gel
|
Placebo
n=151 participants at risk
Vehicle control
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.8%
18/153 • Number of events 18 • 4 weeks
|
11.9%
18/151 • Number of events 18 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.6%
4/153 • Number of events 4 • 4 weeks
|
6.6%
10/151 • Number of events 10 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Contusion
|
3.3%
5/153 • Number of events 5 • 4 weeks
|
2.0%
3/151 • Number of events 3 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
4/153 • Number of events 4 • 4 weeks
|
2.0%
3/151 • Number of events 3 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
3/153 • Number of events 3 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Rhinitis
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Upper respioratory tract infection
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
1.3%
2/151 • Number of events 2 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.3%
2/153 • Number of events 2 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/153 • 4 weeks
|
1.3%
2/151 • Number of events 2 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
2/153 • Number of events 2 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
4/153 • Number of events 4 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
3/153 • Number of events 3 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Surgical and medical procedures
Dental operation
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Eye disorders
Conjonctivitis
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
3/153 • Number of events 3 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
General disorders
Application site pain
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
General disorders
Application site pruritus
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
General disorders
Application site warmth
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
General disorders
Fatigue
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
General disorders
Spinal Pain
|
0.00%
0/153 • 4 weeks
|
1.3%
2/151 • Number of events 2 • 4 weeks
|
|
Immune system disorders
Seasonal allergy
|
1.3%
2/153 • Number of events 2 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Infections and infestations
Bronchitis
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/153 • 4 weeks
|
0.66%
1/151 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.3%
2/153 • Number of events 2 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
|
Infections and infestations
Influenza
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
1.3%
2/151 • Number of events 2 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.65%
1/153 • Number of events 1 • 4 weeks
|
0.00%
0/151 • 4 weeks
|
Additional Information
Clinical Project Leader pain category
Novartis Consumer Health
Phone: +41223633111
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