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| Name | Class |
|---|---|
| Teva Neuroscience, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Sodium Topical Gel first then Placebo | Experimental | 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). |
|
| Placebo first then Diclofenac Sodium Topical Gel | Placebo Comparator | 1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac sodium topical gel | Drug | diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
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Inclusion Criteria:
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)
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.
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| Name | Affiliation | Role |
|---|---|---|
| Ted R Brown, MD, MPH | MS Center at Evergreen Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Center at Evergreen Healthcare | Kirkland | Washington | 98034 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo Followed by Diclofenac Sodium Gel |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diclofenac Sodium Topical Gel | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore R, Brown, MD Principle Investigator | MS Center at Evergreenhealth Care | 425-899-5350 | trbrown@evergreenhealth.com |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Placebo | Other | a placebo gel is applied 1-4 times per day for two weeks. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
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| 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 | The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
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| 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. | The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint | Posted | Mean | Standard Deviation | Likert scale 1-7 (7= best) | 2 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | 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. | 0 | 20 | 1 | 20 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |