Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, diclofenac, subcutaneous injection, glatiramer acetate, Copaxone
Brief summary
The purpose of this study is to assess the effect of Diclofenac Sodium Topical Gel (DSTG) on injection site reaction following self-administer glatiramer acetate in people with Multiple Sclerosis.
Detailed description
A 4 week study with active or placebo medication at randomization and switch treatment at 2-week crossover visit (2 weeks on each arm). There will be a total of 3 visits to the clinic. Subjects will receive instruction on how to apply the DSTG/placebo at the injection site and keep a daily injection site reaction diary.
Interventions
diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo
OTHERPlacebo
a placebo gel is applied 1-4 times per day for two weeks.
Sponsors
Teva Neuroscience, Inc.
Brown, Theodore R., M.D., MPH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Multiple Sclerosis (MS) made at least 3 months prior based on McDonald or Poser criteria. * Age 18 or more * Ongoing treatment with glatiramer acetate (Copaxone) for three months or more. * No MS exacerbation for 60 days prior to screening. * Mean score of greater than or equal to 1.0 on screening Local Injection Site Reaction scale of last 3 days. * Written informed consent.
Exclusion criteria
* Regular use of any non-steroidal anti-inflammatory drug (NDAID), except Asprin (\<325 mg daily), between screening and end of study. * Any contraindication to Diclofenac Sodium Topical Gel (DSTG) * allergy to DSTG or any NSAID. * history of asthma, urticaria, or other allergic reaction after taking any NSAID. * Females who are breast feeding, pregnant or have potential to become pregnant during the course of the study(fertile and unwilling/unable to use effective contraceptive measures). * Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing. * Any other serious and/or unstable medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks | 2 weeks | 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. |
| Pain Scale at 2 Weeks | 2 weeks | 0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Global Impression at 2 Weeks | 2 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Placebo Followed by Diclofenac Sodium Gel 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Diclofenac Sodium Topical Gel Followed by Placebo | Placebo Followed by Diclofenac Sodium Gel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 19 Participants | 38 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 17 Participants | 33 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
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.
Time frame: 2 weeks
Population: The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Topical Gel | Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks | 3.39 units on a scale | Standard Deviation 0.19 |
| Placebo | Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks | 3.47 units on a scale | Standard Deviation 0.19 |
p-value: 0.45t-test, 2 sided
Primary
Pain Scale at 2 Weeks
0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst
Time frame: 2 weeks
Population: The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Topical Gel | Pain Scale at 2 Weeks | 2.44 units on a scale | Standard Deviation 0.28 |
| Placebo | Pain Scale at 2 Weeks | 2.60 units on a scale | Standard Deviation 0.28 |
p-value: 0.6059t-test, 2 sided
Secondary
Subject Global Impression at 2 Weeks
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.
Time frame: 2 weeks
Population: The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Sodium Topical Gel | Subject Global Impression at 2 Weeks | 4.68 Likert scale 1-7 (7= best) | Standard Deviation 0.17 |
| Placebo | Subject Global Impression at 2 Weeks | 4.50 Likert scale 1-7 (7= best) | Standard Deviation 0.17 |
p-value: 0.705t-test, 2 sided