Assessing Tolerability of Avonex Intramuscular Injections
Assessing Tolerability of Avonex Intramuscular Injections With a 25 Gauge Needle Versus 30 Gauge Needle
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Visual Analog Scale Score for Post-injection Pain | 0.035 | ||
| Change in Patient Visual Analog Scale Score for Pre-injection Anxiety | <.05 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Results by group
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
Weeks 2, 3, 4, 5
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 25 Gauge | 1.58 cm | 2.25 (Standard Deviation) | 20 |
| 30 Gauge | 2.22 cm | 2.73 (Standard Deviation) | 20 |
25 Gauge
30 Gauge
p = <.05
Visual Analog Scale Score for Post-injection Pain
Weeks 2, 3, 4, 5
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| 25 Gauge | 1.201 cm | 1.22 (Standard Deviation) | 20 |
| 30 Gauge | 0.764 cm | 0.93 (Standard Deviation) | 20 |
25 Gauge
30 Gauge
p = 0.035
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| 25 Gauge | 20 | 0 (0.0%) | |
| 30 Gauge | 20 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Patient Visual Analog Scale Score for Pre-injection Anxiety
Weeks 2, 3, 4, 5
Mood and sleepVisual Analog Scale Score for Post-injection Pain
Weeks 2, 3, 4, 5
Pain
Other measures (2)
Fear of Injection
Weeks 2, 3, 4, 5
Perception of Needle
Weeks 2, 3, 4, 5
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
* Between 18 - 65 years of age; * Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis; * Currently being treated with Avonex® for at least 90 days; * Using 25 gauge needles for injection of Avonex® for at least 90 days; * Willing and able to complete study questionnaires; and * Provided informed consent to participate in this study
Exclusion criteria
* Diagnosis of Progressive Multiple Sclerosis; * History of recent illness or infection; * History of allergic reaction to Avonex®; * Any prior usage of a 30 gauge needle for administration of Avonex®; * Concurrent treatment with other immunomodulating therapies; * Pregnant or planning on becoming pregnant; * Nursing mothers; and * Unable to complete the requirements of the study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to evaluate patients' views when injecting Avonex intramuscularly.
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History
Started
May 2012
Main results due
Feb 2014
Finished
Feb 2014
Results posted
Feb 2016