Phase 4
Completed N=40
Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
Source: ClinicalTrials.gov NCT01454791 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks — 3.39; 3.47 units on a scale — p=0.45
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks |
3.39; 3.47 | 0.45 |
| PRIMARY Pain Scale at 2 Weeks |
2.44; 2.60 | 0.6059 |
| SECONDARY Subject Global Impression at 2 Weeks |
4.68; 4.50 | 0.705 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01454791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.