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Phase 4 N=40 Randomized Double-blind Prevention

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

Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT01454791 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks — 3.39; 3.47 units on a scale — p=0.45

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
diclofenac sodium topical gel (Drug); Placebo (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Brown, Theodore R., M.D., MPH
Primary completion
Mar 2013

Outcome Measures

OutcomeResultp-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

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.

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.
View full record on ClinicalTrials.gov →

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.

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