Trial Outcomes & Findings for Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis (NCT NCT01119898)
NCT ID: NCT01119898
Last Updated: 2019-10-22
Results Overview
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
260 participants
Primary outcome timeframe
at Baseline
Results posted on
2019-10-22
Participant Flow
One person who failed screening was randomized in error, but did not receive study drug.
Participant milestones
| Measure |
PENNSAID Gel
Diclofenac sodium 2.0% w/w
|
Vehicle
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
129
|
|
Overall Study
Received Study Drug (mITT)
|
130
|
129
|
|
Overall Study
COMPLETED
|
123
|
117
|
|
Overall Study
NOT COMPLETED
|
8
|
12
|
Reasons for withdrawal
| Measure |
PENNSAID Gel
Diclofenac sodium 2.0% w/w
|
Vehicle
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Medical procedure
|
1
|
0
|
|
Overall Study
Randomized in error did not participate
|
1
|
0
|
Baseline Characteristics
Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
PENNSAID Gel
n=130 Participants
Diclofenac sodium 2.0% w/w
|
Vehicle
n=129 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 9.23 • n=99 Participants
|
61.9 years
STANDARD_DEVIATION 9.07 • n=107 Participants
|
61.1 years
STANDARD_DEVIATION 9.17 • n=206 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=99 Participants
|
129 participants
n=107 Participants
|
259 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at BaselinePopulation: mITT population
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=129 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=130 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain When Walking On A Flat Surface
None
|
1 Participants
|
0 Participants
|
|
Pain When Walking On A Flat Surface
Mild
|
4 Participants
|
8 Participants
|
|
Pain When Walking On A Flat Surface
Moderate
|
67 Participants
|
62 Participants
|
|
Pain When Walking On A Flat Surface
Severe
|
43 Participants
|
51 Participants
|
|
Pain When Walking On A Flat Surface
Extreme
|
14 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: at Week 4Population: mITT population with non-missing data at Week 4
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=118 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=123 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain When Walking On A Flat Surface
None
|
19 Participants
|
19 Participants
|
|
Pain When Walking On A Flat Surface
Mild
|
38 Participants
|
47 Participants
|
|
Pain When Walking On A Flat Surface
Moderate
|
51 Participants
|
45 Participants
|
|
Pain When Walking On A Flat Surface
Severe
|
10 Participants
|
11 Participants
|
|
Pain When Walking On A Flat Surface
Extreme
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: at BaselinePopulation: mITT population
Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=129 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=130 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain When Going Up Or Down Stairs
None
|
0 Participants
|
0 Participants
|
|
Pain When Going Up Or Down Stairs
Mild
|
1 Participants
|
1 Participants
|
|
Pain When Going Up Or Down Stairs
Moderate
|
14 Participants
|
14 Participants
|
|
Pain When Going Up Or Down Stairs
Severe
|
84 Participants
|
80 Participants
|
|
Pain When Going Up Or Down Stairs
Extreme
|
30 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: at Week 4Population: mITT population with non-missing data at Week 4
Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=118 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=123 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain When Going Up Or Down Stairs
Mild
|
32 Participants
|
34 Participants
|
|
Pain When Going Up Or Down Stairs
Moderate
|
37 Participants
|
51 Participants
|
|
Pain When Going Up Or Down Stairs
None
|
4 Participants
|
4 Participants
|
|
Pain When Going Up Or Down Stairs
Severe
|
40 Participants
|
29 Participants
|
|
Pain When Going Up Or Down Stairs
Extreme
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: at BaselinePopulation: mITT population with non-missing data at Baseline
Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=129 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=129 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain At Night While In Bed
Moderate
|
50 Participants
|
60 Participants
|
|
Pain At Night While In Bed
None
|
6 Participants
|
5 Participants
|
|
Pain At Night While In Bed
Mild
|
26 Participants
|
23 Participants
|
|
Pain At Night While In Bed
Severe
|
33 Participants
|
32 Participants
|
|
Pain At Night While In Bed
Extreme
|
14 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: at Week 4Population: mITT population with non-missing data at Week 4
Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=118 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=123 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain At Night While In Bed
None
|
30 Participants
|
37 Participants
|
|
Pain At Night While In Bed
Mild
|
45 Participants
|
45 Participants
|
|
Pain At Night While In Bed
Moderate
|
35 Participants
|
34 Participants
|
|
Pain At Night While In Bed
Severe
|
8 Participants
|
5 Participants
|
|
Pain At Night While In Bed
Extreme
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: at BaselinePopulation: mITT population
Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=129 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=130 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain While Sitting Or Lying Down
None
|
4 Participants
|
1 Participants
|
|
Pain While Sitting Or Lying Down
Mild
|
22 Participants
|
30 Participants
|
|
Pain While Sitting Or Lying Down
Moderate
|
63 Participants
|
63 Participants
|
|
Pain While Sitting Or Lying Down
Severe
|
28 Participants
|
30 Participants
|
|
Pain While Sitting Or Lying Down
Extreme
|
12 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: at Week 4Population: mITT population with non-missing data at Week 4
Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=118 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=123 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain While Sitting Or Lying Down
None
|
25 Participants
|
36 Participants
|
|
Pain While Sitting Or Lying Down
Mild
|
55 Participants
|
46 Participants
|
|
Pain While Sitting Or Lying Down
Moderate
|
34 Participants
|
36 Participants
|
|
Pain While Sitting Or Lying Down
Severe
|
4 Participants
|
5 Participants
|
|
Pain While Sitting Or Lying Down
Extreme
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: at BaselinePopulation: mITT population
Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=129 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=130 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain While Standing
Moderate
|
52 Participants
|
54 Participants
|
|
Pain While Standing
None
|
2 Participants
|
0 Participants
|
|
Pain While Standing
Mild
|
6 Participants
|
7 Participants
|
|
Pain While Standing
Severe
|
51 Participants
|
53 Participants
|
|
Pain While Standing
Extreme
|
18 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: at Week 4Population: mITT population with non-missing data at Week 4
Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Outcome measures
| Measure |
Vehicle
n=118 Participants
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
PENNSAID Gel
n=123 Participants
Diclofenac sodium 2.0% w/w
PENNSAID Gel: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
|
|---|---|---|
|
Pain While Standing
None
|
13 Participants
|
15 Participants
|
|
Pain While Standing
Mild
|
42 Participants
|
47 Participants
|
|
Pain While Standing
Moderate
|
50 Participants
|
49 Participants
|
|
Pain While Standing
Severe
|
11 Participants
|
11 Participants
|
|
Pain While Standing
Extreme
|
2 Participants
|
1 Participants
|
Adverse Events
PENNSAID Gel
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PENNSAID Gel
n=130 participants at risk
Diclofenac sodium 2.0% w/w
|
Vehicle
n=129 participants at risk
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
|
|---|---|---|
|
General disorders
Application site dryness
|
21.5%
28/130 • 6 months
Participants were only counted once for each body system/preferred term.
|
21.7%
28/129 • 6 months
Participants were only counted once for each body system/preferred term.
|
|
General disorders
Application site exfoliation
|
6.9%
9/130 • 6 months
Participants were only counted once for each body system/preferred term.
|
8.5%
11/129 • 6 months
Participants were only counted once for each body system/preferred term.
|
|
General disorders
Application site erythema
|
3.8%
5/130 • 6 months
Participants were only counted once for each body system/preferred term.
|
11.6%
15/129 • 6 months
Participants were only counted once for each body system/preferred term.
|
|
General disorders
Application site pruritis
|
2.3%
3/130 • 6 months
Participants were only counted once for each body system/preferred term.
|
14.0%
18/129 • 6 months
Participants were only counted once for each body system/preferred term.
|
Additional Information
Medical Information Call Center
Mallinckrodt Pharmaceuticals
Phone: 800-556-3314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place