Back to results

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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

diclofenac sodium topical gel

Placebo

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring multiple sclerosis, diclofenac, subcutaneous injection, glatiramer acetate, Copaxone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

MS Center at Evergreen Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac Sodium Topical Gel first then Placebo

Placebo first then Diclofenac Sodium Topical Gel

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01454791

First Posted

August 9, 2011

Last Updated

February 12, 2015

Sponsor

Brown, Theodore R., M.D., MPH

Collaborators

Teva Neuroscience, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01454791

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brown, Theodore R., M.D., MPH

Collaborators

Teva Neuroscience, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

multiple sclerosis, diclofenac, subcutaneous injection, glatiramer acetate, Copaxone

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diclofenac Sodium Topical Gel first then Placebo

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo first then Diclofenac Sodium Topical Gel

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

diclofenac sodium topical gel

Other Intervention Name(s)

Voltaren gel

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks

Description

Time Frame

2 weeks

Title

Pain Scale at 2 Weeks

Description

0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Subject Global Impression at 2 Weeks

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ted R Brown, MD, MPH

Organizational Affiliation

MS Center at Evergreen Healthcare

Official's Role

Principal Investigator

Facility Information:

Facility Name

MS Center at Evergreen Healthcare

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs