Trial Outcomes & Findings for Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1% (NCT NCT02913521)

Results Overview

WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

934 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Diclofenac Sodium Gel 1% Apply 4 g of gel to the knee four times a day Diclofenac Sodium Gel 1%	Voltaren Gel Apply 4 g of gel to the knee four times a day Voltaren Gel	Placebo Apply 4 g of gel to the knee four times a day Placebo
Overall Study STARTED	316	312	306
Overall Study COMPLETED	263	262	261
Overall Study NOT COMPLETED	53	50	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ITT population described below

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac Sodium Gel 1% n=263 Participants Apply 4 g of gel to the knee four times a day Diclofenac Sodium Gel 1%	Voltaren Gel n=262 Participants Apply 4 g of gel to the knee four times a day Voltaren Gel	Placebo n=261 Participants Apply 4 g of gel to the knee four times a day Placebo	Total n=786 Participants Total of all reporting groups
Age, Continuous	58 year STANDARD_DEVIATION 10.3 • n=5 Participants • ITT population described below	58 year STANDARD_DEVIATION 11.1 • n=7 Participants • ITT population described below	57 year STANDARD_DEVIATION 10.8 • n=5 Participants • ITT population described below	57.3 year STANDARD_DEVIATION 11 • n=4 Participants • ITT population described below
Sex: Female, Male Female	200 Participants n=5 Participants • ITT population	193 Participants n=7 Participants • ITT population	190 Participants n=5 Participants • ITT population	583 Participants n=4 Participants • ITT population
Sex: Female, Male Male	63 Participants n=5 Participants • ITT population	69 Participants n=7 Participants • ITT population	71 Participants n=5 Participants • ITT population	203 Participants n=4 Participants • ITT population

PRIMARY outcome

Timeframe: 8 weeks

WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20).

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Gel 1% n=258 Participants Apply 4 g of gel to the knee four times a day Diclofenac Sodium Gel 1%	Voltaren Gel n=255 Participants Apply 4 g of gel to the knee four times a day Voltaren Gel	Placebo n=257 Participants Apply 4 g of gel to the knee four times a day Placebo
Mean Change From Baseline to Week 8 in WOMAC Pain Scale, Bioequivalence of Test to Reference.	6.8 units on a scale Standard Deviation 2.1	6.7 units on a scale Standard Deviation 2.3	5.9 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: 8 weeks

Population: mITT

WOMAC = Western Ontario and McMaster Universities Arthritis Index. The higher number is more pain. Change from baseline to Week 8 as indicated in the title. Scale is 5 questions with a scale of 0-4, higher number is more pain. Therefore, if you have 5 questions and the max score for each is 4, the maximum number on the scale is 20 (5 questions x 4 units on the scale = 20).

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Gel 1% n=263 Participants Apply 4 g of gel to the knee four times a day Diclofenac Sodium Gel 1%	Voltaren Gel n=262 Participants Apply 4 g of gel to the knee four times a day Voltaren Gel	Placebo n=261 Participants Apply 4 g of gel to the knee four times a day Placebo
An Evaluation to Determine Superiority of Test and Reference Against Placebo in the Mean Change From Baseline to Week 8 in the Total WOMAC Pain Score.	6.8 units on a scale Standard Deviation 1.9	6.6 units on a scale Standard Deviation 2.0	5.9 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Diclofenac Sodium Gel 1%

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Voltaren Gel

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diclofenac Sodium Gel 1% n=316 participants at risk Apply 4 g of gel to the knee four times a day Diclofenac Sodium Gel 1%	Voltaren Gel n=312 participants at risk Apply 4 g of gel to the knee four times a day Voltaren Gel	Placebo n=306 participants at risk Apply 4 g of gel to the knee four times a day Placebo
Skin and subcutaneous tissue disorders application site reaction	1.9% 6/316 • Number of events 316	1.3% 4/312 • Number of events 312	0.98% 3/306 • Number of events 306
Investigations General disorders, muscle/skeletal, and nervous system	7.6% 24/316 • Number of events 316	6.4% 20/312 • Number of events 312	5.6% 17/306 • Number of events 306

Additional Information

Kalev Kask

Egeen

Phone: 16504690600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place