Multiple SclerosisPhase 4NCT00239993
A Study to Evaluate the Impact of Using Warm Compress Prior to Daily Injections of Copaxone®
A Phase 4 study testing glatiramer acetate and Warm compress prior to injection of glatiramer acetate in people with Multiple Sclerosis, run by Teva Neuroscience, Inc. at 6 sites in United States.
Trial summary
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- glatiramer acetate and Warm compress prior to injection of glatiramer acetate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2005to Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or Female, 18 years or older, with a diagnosis of RRMS
- Willing and able to complete all procedures and evaluations related to the study.
- Willing to provide Informed Consent
Who cannot join
- Taking any other immunomodulatory therapy in conjunction with Copaxone®.
- Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
- Any situation which the investigator or nurse feels may interfere with participation in the study.
- Pregnant, or trying to become pregnant, or breast feeding during the study.
- Previously participated in this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Multiple Sclerosis Care Center
Brooklyn, New York
Fullerton Neurology & Headache Center
Fullerton, California
Neurological Center of South Florida
Miami, Florida
Advanced Neurosciences Institute
Nashville, Tennessee
Springfield Neurology Associates
Springfield, Massachusetts
Virginia Beach Neurology
Virginia Beach, Virginia
About this study
Official title: An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.
- Conditions
- Multiple Sclerosis
- Being tested
- glatiramer acetate, Warm compress prior to injection of glatiramer acetate
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glatiramer acetateDrug
Also called Copaxone
Warm compress prior to injection of glatiramer acetateProcedure or surgery
Also called Copaxone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | skin reactions with the use of warm compress prior to performing a Copaxone® injection Receives: Drug: glatiramer acetate |
| 2 | Experimental | skin reactions without the use of warm compress prior to performing a Copaxone® injection Receives: Procedure: Warm compress prior to injection of glatiramer acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
Measured: 2-week diaries kept by the patients for Period 1 and for Period 2
Secondary outcomes (1)
The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection
Measured: 2-week diaries kept by the patients for Period 1 and for Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MerriKay Oleen-Burkey, Ph.D, Study director, Teva Neuroscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239993
- Sponsor's protocol ID
- PM016
- Status last verified
- Feb 2017
- First submitted
- 22 Sep 2005
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single Cross-over Study of Warm Compress Versus Usual Injection Site Preparation on Local Injection Site Reactions Among Persons With MS Who Perform Daily Injections of Copaxone®.
- ClinicalTrials.gov ID
- NCT00239993
- Acronym / sponsor ID
- PM016
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Teva Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare skin reactions with or without the use of warm compress prior to performing a Copaxone® injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: glatiramer acetateskin reactions with the use of warm compress prior to performing a Copaxone® injection |
| 2 | Experimental | Procedure: Warm compress prior to injection of glatiramer acetateskin reactions without the use of warm compress prior to performing a Copaxone® injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or Female, 18 years or older, with a diagnosis of RRMS
- Willing and able to complete all procedures and evaluations related to the study.
- Willing to provide Informed Consent
Key exclusion criteria (5 listed)
- Taking any other immunomodulatory therapy in conjunction with Copaxone®.
- Has a significant medical illness other than MS which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
- Any situation which the investigator or nurse feels may interfere with participation in the study.
- Pregnant, or trying to become pregnant, or breast feeding during the study.
- Previously participated in this study.
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 |
|---|---|---|
| glatiramer acetateAlso: Copaxone | Drug | 1 |
| Warm compress prior to injection of glatiramer acetateAlso: Copaxone | Procedure or surgery | 2 |
Primary outcome
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection
Time frame: 2-week diaries kept by the patients for Period 1 and for Period 2
1 secondary outcome
The total and partial number of LISRs noted at 2-minutes post-injection The total and partial number of LISRs noted immediately after injection
Time frame: 2-week diaries kept by the patients for Period 1 and for Period 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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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.
MerriKay Oleen-Burkey, Ph.D study director
Teva Neuroscience, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing glatiramer acetate and Warm compress prior to injection of glatiramer acetate in people with Multiple Sclerosis, run by Teva Neuroscience, Inc. at 6 sites 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 3 inclusion and 5 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 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of local injection site reactions (LISRs) noted at 5-minutes post-injection (time frame: 2-week diaries kept by the patients for Period 1 and for Period 2). 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 6 Feb 2017.