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=5 Participants	61.9 years STANDARD_DEVIATION 9.07 • n=7 Participants	61.1 years STANDARD_DEVIATION 9.17 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	90 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	39 Participants n=7 Participants	85 Participants n=5 Participants
Region of Enrollment United States	130 participants n=5 Participants	129 participants n=7 Participants	259 participants n=5 Participants

PRIMARY outcome

Timeframe: at Baseline

Population: 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	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	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
Pain When Walking On A Flat Surface None	0 Participants	1 Participants
Pain When Walking On A Flat Surface Mild	8 Participants	4 Participants
Pain When Walking On A Flat Surface Moderate	62 Participants	67 Participants
Pain When Walking On A Flat Surface Severe	51 Participants	43 Participants
Pain When Walking On A Flat Surface Extreme	9 Participants	14 Participants

PRIMARY outcome

Timeframe: at Week 4

Population: 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	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	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
Pain When Walking On A Flat Surface None	19 Participants	19 Participants
Pain When Walking On A Flat Surface Mild	47 Participants	38 Participants
Pain When Walking On A Flat Surface Moderate	45 Participants	51 Participants
Pain When Walking On A Flat Surface Severe	11 Participants	10 Participants
Pain When Walking On A Flat Surface Extreme	1 Participants	0 Participants

PRIMARY outcome

Timeframe: at Baseline

Population: 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	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	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
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	80 Participants	84 Participants
Pain When Going Up Or Down Stairs Extreme	35 Participants	30 Participants

PRIMARY outcome

Timeframe: at Week 4

Population: 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	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	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
Pain When Going Up Or Down Stairs None	4 Participants	4 Participants
Pain When Going Up Or Down Stairs Mild	34 Participants	32 Participants
Pain When Going Up Or Down Stairs Moderate	51 Participants	37 Participants
Pain When Going Up Or Down Stairs Severe	29 Participants	40 Participants
Pain When Going Up Or Down Stairs Extreme	5 Participants	5 Participants

PRIMARY outcome

Timeframe: at Baseline

Population: 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	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	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
Pain At Night While In Bed None	5 Participants	6 Participants
Pain At Night While In Bed Mild	23 Participants	26 Participants
Pain At Night While In Bed Moderate	60 Participants	50 Participants
Pain At Night While In Bed Severe	32 Participants	33 Participants
Pain At Night While In Bed Extreme	9 Participants	14 Participants

PRIMARY outcome

Timeframe: at Week 4

Population: 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	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	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
Pain At Night While In Bed None	37 Participants	30 Participants
Pain At Night While In Bed Mild	45 Participants	45 Participants
Pain At Night While In Bed Moderate	34 Participants	35 Participants
Pain At Night While In Bed Severe	5 Participants	8 Participants
Pain At Night While In Bed Extreme	2 Participants	0 Participants

PRIMARY outcome

Timeframe: at Baseline

Population: 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	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	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
Pain While Sitting Or Lying Down None	1 Participants	4 Participants
Pain While Sitting Or Lying Down Mild	30 Participants	22 Participants
Pain While Sitting Or Lying Down Moderate	63 Participants	63 Participants
Pain While Sitting Or Lying Down Severe	30 Participants	28 Participants
Pain While Sitting Or Lying Down Extreme	6 Participants	12 Participants

PRIMARY outcome

Timeframe: at Week 4

Population: 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	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	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
Pain While Sitting Or Lying Down None	36 Participants	25 Participants
Pain While Sitting Or Lying Down Mild	46 Participants	55 Participants
Pain While Sitting Or Lying Down Moderate	36 Participants	34 Participants
Pain While Sitting Or Lying Down Severe	5 Participants	4 Participants
Pain While Sitting Or Lying Down Extreme	0 Participants	0 Participants

PRIMARY outcome

Timeframe: at Baseline

Population: 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	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	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
Pain While Standing None	0 Participants	2 Participants
Pain While Standing Mild	7 Participants	6 Participants
Pain While Standing Moderate	54 Participants	52 Participants
Pain While Standing Severe	53 Participants	51 Participants
Pain While Standing Extreme	16 Participants	18 Participants

PRIMARY outcome

Timeframe: at Week 4

Population: 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	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	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
Pain While Standing None	15 Participants	13 Participants
Pain While Standing Mild	47 Participants	42 Participants
Pain While Standing Moderate	49 Participants	50 Participants
Pain While Standing Severe	11 Participants	11 Participants
Pain While Standing Extreme	1 Participants	2 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: clinicaltrials@mnk.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place