Multiple SclerosisPhase 4NCT00220922
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Using Alcohol Wipes Prior to Daily Injections of Copaxone®.
A Phase 4 study testing Alcohol Wipes vs. No Alcohol Wipes in people with Multiple Sclerosis, run by Teva Neuroscience, Inc..
Trial summary
This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection. 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?
- Alcohol Wipes vs. No Alcohol Wipes
- 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
- No sites listed yet
- Study dates
- Aug 2004to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female
- 18 years of age or older
- Diagnosis of RRMS
- Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously
Who cannot join
- Unable to perform subcutaneous self-injection
- Pregnant, or trying to become pregnant, or breast feeding during the study
About this study
Official title: An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®
This study is designed to compare injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection.
- Conditions
- Multiple Sclerosis
- Being tested
- Alcohol Wipes vs. No Alcohol Wipes
- Keywords
- 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.
Alcohol Wipes vs. No Alcohol WipesProcedure or surgery
Also called Copaxone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | injection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection Receives: Procedure: Alcohol Wipes vs. No Alcohol Wipes |
| 2 | Experimental | injection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection Receives: Procedure: Alcohol Wipes vs. No Alcohol Wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
Measured: four weeks of Period 1 and the four weeks of Period 2
Secondary outcomes (1)
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection
Measured: four weeks of Period 1 and the four weeks of Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionOct 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
- NCT00220922
- Sponsor's protocol ID
- PM013
- Status last verified
- Apr 2011
- First submitted
- 20 Sep 2005
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single Cross-Over Study of Isopropyl Alcohol Wipes Versus No Injection Site Preparation on Local Injection Site Reactions Among Persons With Multiple Sclerosis Who Perform Daily Injections of Copaxone®
- ClinicalTrials.gov ID
- NCT00220922
- Acronym / sponsor ID
- PM013
- Conditions
- Multiple Sclerosis
- Keywords
- Copaxone
- 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 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 22 Sep 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 injection site reactions with or without the use of alcohol wipes prior to performing the patients' daily 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 | Procedure: Alcohol Wipes vs. No Alcohol Wipesinjection site reactions with the use of alcohol wipes prior to performing the patients' daily Copaxone® injection |
| 2 | Experimental | Procedure: Alcohol Wipes vs. No Alcohol Wipesinjection site reactions without the use of alcohol wipes prior to performing the patients' daily Copaxone® injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female
- 18 years of age or older
- Diagnosis of RRMS
- Beginning or recently (within 3 months) began self-injecting Copaxone® subcutaneously
Key exclusion criteria (2 listed)
- Unable to perform subcutaneous self-injection
- Pregnant, or trying to become pregnant, or breast feeding during the 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 |
|---|---|---|
| Alcohol Wipes vs. No Alcohol WipesAlso: Copaxone | Procedure or surgery | 1, 2 |
Primary outcome
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection
Time frame: four weeks of Period 1 and the four weeks of Period 2
1 secondary outcome
The total number of LISRs noted at 2-minutes post-injection The total number of LISRs noted immediately after injection
Time frame: four weeks of Period 1 and the four weeks of 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 8 Apr 2011.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alcohol Wipes vs. No Alcohol Wipes in people with Multiple Sclerosis, run by Teva Neuroscience, Inc..
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 4 inclusion and 2 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 8 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Total number of local injection site reactions (LISRs) noted at 5-minutes post-injection (time frame: four weeks of Period 1 and the four weeks of 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 8 Apr 2011.