Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in P
Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients With Multiple Sclerosis Taking Glatiramer Acetate: A Randomized Controlled Double- Blind Crossover Trial
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks | Mean Difference (Final Values) -0.08 | 0.45 | |
| Pain Scale at 2 Weeks | Mean Difference (Final Values) -0.16 | 0.6059 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- diclofenac sodium topical gel
Placebo
- Placebo
Results by group
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
2 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Diclofenac Sodium Topical Gel | 3.39 units on a scale | 0.19 (Standard Deviation) | 40 |
| Placebo | 3.47 units on a scale | 0.19 (Standard Deviation) | 40 |
Diclofenac Sodium Topical Gel
Placebo
p = 0.45; Mean Difference (Final Values) -0.08
Pain Scale at 2 Weeks
2 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Diclofenac Sodium Topical Gel | 2.44 units on a scale | 0.28 (Standard Deviation) | 40 |
| Placebo | 2.60 units on a scale | 0.28 (Standard Deviation) | 40 |
Diclofenac Sodium Topical Gel
Placebo
p = 0.6059; Mean Difference (Final Values) -0.16
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Diclofenac Sodium Topical Gel | 20 | 0 (0.0%) | |
| Placebo | 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
Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks
2 weeks
PainSafetyPain Scale at 2 Weeks
2 weeks
PainSafety
Other measures (1)
Subject Global Impression at 2 Weeks
2 weeks
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
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 assess the effect of Diclofenac Sodium Topical Gel (DSTG) on injection site reaction following self-administer glatiramer acetate in people with Multiple Sclerosis.
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History
Started
Jan 2011
Main results due
Mar 2013
Finished
Mar 2013
Results posted
Feb 2015