NCT01454791

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 multiple-sclerosis

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 13, 2015

Completed
Last Updated

March 5, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

August 9, 2011

Results QC Date

July 22, 2014

Last Update Submit

February 12, 2015

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisdiclofenacsubcutaneous injectionglatiramer acetateCopaxone

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Subject Global Impression at 2 Weeks

    2 weeks

Study Arms (2)

Diclofenac Sodium Topical Gel first then Placebo

EXPERIMENTAL

1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

Drug: diclofenac sodium topical gelOther: Placebo

Placebo first then Diclofenac Sodium Topical Gel

PLACEBO COMPARATOR

1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).

Drug: diclofenac sodium topical gelOther: Placebo

Interventions

diclofenac sodium topical gelDRUG

diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo

Also known as: Voltaren gel
Diclofenac Sodium Topical Gel first then PlaceboPlacebo first then Diclofenac Sodium Topical Gel
PlaceboOTHER

a placebo gel is applied 1-4 times per day for two weeks.

Diclofenac Sodium Topical Gel first then PlaceboPlacebo first then Diclofenac Sodium Topical Gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MS Center at Evergreen Healthcare

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Theodore R, Brown, MD Principle Investigator
Organization
MS Center at Evergreenhealth Care
trbrown@evergreenhealth.com
425-899-5350

Study Officials

  • Ted R Brown, MD, MPH

    MS Center at Evergreen Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2011

First Posted

October 19, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 5, 2015

Results First Posted

February 13, 2015

Record last verified: 2015-01

Locations

US(1)