Multiple SclerosisPhase 4NCT01454791
Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate
A Phase 4 study testing diclofenac sodium topical gel in people with Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- diclofenac sodium topical gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
MS Center at Evergreen Healthcare
Kirkland, Washington, 98034
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- diclofenac sodium topical gel, Placebo
- Keywords
- multiple sclerosis, diclofenac, subcutaneous injection, glatiramer acetate, Copaxone
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac sodium topical gelDrug
Also called Voltaren 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
PlaceboOther
a placebo gel is applied 1-4 times per day for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: diclofenac sodium topical gel; Other: 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). Receives: Drug: diclofenac sodium topical gel; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Teva Neuroscience, Inc.
- Responsible party
- Sponsor
- Investigators
- Ted R Brown, MD, MPH, Principal investigator, MS Center at Evergreen Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454791
- Sponsor's protocol ID
- WIRB 20101775
- Status last verified
- Jan 2015
- First submitted
- 9 Aug 2011
- Last updated
- 5 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01454791
- Acronym / sponsor ID
- WIRB 20101775
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, diclofenac, subcutaneous injection, glatiramer acetate, Copaxone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Collaborators
- Teva Neuroscience, Inc.
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Posted 13 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Sodium Topical Gel first then Placebo | Experimental | Drug: diclofenac sodium topical gel, Other: Placebo1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). |
| Placebo first then Diclofenac Sodium Topical Gel | Placebo comparator | Drug: diclofenac sodium topical gel, Other: Placebo1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diclofenac sodium topical gelAlso: Voltaren geldiclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo | Drug | Diclofenac Sodium Topical Gel first then Placebo, Placebo first then Diclofenac Sodium Topical Gel |
| Placeboa placebo gel is applied 1-4 times per day for two weeks. | Other | Diclofenac Sodium Topical Gel first then Placebo, Placebo first then Diclofenac Sodium Topical Gel |
Primary outcome
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
Time frame: 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
Time frame: 2 weeks
0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst
1 secondary outcome
Subject Global Impression at 2 Weeks
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted R Brown, MD, MPH principal investigator
MS Center at Evergreen Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diclofenac sodium topical gel in people with Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.