View Clinical Trial (Medical Research Study)

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials

---

Conditions:		Multiple Sclerosis
Purpose:		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.
Study Summary:		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.
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.
NCT ID:		NCT01454791
Primary Contact:		Principal Investigator Ted R Brown, MD, MPH MS Center at Evergreen Healthcare
Backup Contact:		N/A
Location Contact:		Kirkland, Washington 98034 United States There is no listed contact information for this specific location. Site Status: N/A

---

---