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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454791
• Other study ID #: WIRB 20101775
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2011
• Last updated: February 12, 2015
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: Brown, Theodore R., M.D., MPH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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

Other:
• Placebo
a placebo gel is applied 1-4 times per day for two weeks.

Locations

Country	Name	City	State
United States	MS Center at Evergreen Healthcare	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Brown, Theodore R., M.D., MPH	Teva Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 weeks	No
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	2 weeks	No
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.	2 weeks	No