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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01454791 |
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Date of registration:
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09/08/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
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Scientific title:
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Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01454791 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Ted R Brown, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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MS Center at Evergreen Healthcare |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Other: Placebo
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Drug: diclofenac sodium topical gel
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Primary Outcome(s)
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Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
[Time Frame: 2 weeks]
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Pain Scale at 2 Weeks
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Subject Global Impression at 2 Weeks
[Time Frame: 2 weeks]
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Secondary ID(s)
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WIRB 20101775
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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