Trial Outcomes & Findings for Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate (NCT NCT01454791)

Results Overview

patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

2 weeks

Results posted on

2015-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Diclofenac Sodium Topical Gel Followed by Placebo diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo Placebo: a placebo gel is applied 1-4 times per day for two weeks.	Placebo Followed by Diclofenac Sodium Topical Gel Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks Placebo: a placebo gel is applied 1-4 times per day for two weeks.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac Sodium Topical Gel Followed by Placebo n=20 Participants diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo Placebo: a placebo gel is applied 1-4 times per day for two weeks.	Placebo Followed by Diclofenac Sodium Gel n=20 Participants placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks Placebo: a placebo gel is applied 1-4 times per day for two weeks.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint

patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Topical Gel n=40 Participants diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks	Placebo n=40 Participants Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks	3.39 units on a scale Standard Deviation 0.19	3.47 units on a scale Standard Deviation 0.19

PRIMARY outcome

Timeframe: 2 weeks

Population: The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint

0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Topical Gel n=40 Participants diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks	Placebo n=40 Participants Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
Pain Scale at 2 Weeks	2.44 units on a scale Standard Deviation 0.28	2.60 units on a scale Standard Deviation 0.28

SECONDARY outcome

Timeframe: 2 weeks

Population: The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint

This is a single question: "How would you rate your level of comfort with Copaxone injection during the past two weeks?" Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad.

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Topical Gel n=40 Participants diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks	Placebo n=40 Participants Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
Subject Global Impression at 2 Weeks	4.68 Likert scale 1-7 (7= best) Standard Deviation 0.17	4.50 Likert scale 1-7 (7= best) Standard Deviation 0.17

Adverse Events

Diclofenac Sodium Topical Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diclofenac Sodium Topical Gel n=20 participants at risk 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo Placebo: a placebo gel is applied 1-4 times per day for two weeks.	Placebo n=20 participants at risk 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo Placebo: a placebo gel is applied 1-4 times per day for two weeks.
Skin and subcutaneous tissue disorders urticaria	0.00% 0/20	5.0% 1/20 • Number of events 1

Additional Information

Theodore R, Brown, MD Principle Investigator

MS Center at Evergreenhealth Care

Phone: 425-899-5350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place