Clinical Trial Results:
Multicentre, prospective, double-blind, in parallel groups, randomized, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic lateral epicondylitis (tennis elbow)
Summary
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EudraCT number |
2014-004119-35 |
Trial protocol |
IT |
Global end of trial date |
11 May 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2020
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First version publication date |
01 Jan 2020
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
14I-BMT09
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
IBSA Institut Biochimique SA
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Sponsor organisation address |
via del piano 29, Pambio Noranco, Switzerland,
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Public contact |
R&D Scientific Affairs Dept., IBSA Institut Biochimique SA, +41 583601000, sd@ibsa.ch
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Scientific contact |
R&D Scientific Affairs Dept., IBSA Institut Biochimique SA, +41 583601000, sd@ibsa.ch
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Dec 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 May 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
11 May 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to investigate the ability of betamethasone valerate 2.25 mg medicated plaster, as compared to placebo plaster (same formulation but without active ingredient), to significantly reduce pain in patients suffering from chronic lateral elbow tendinopathy, when topically applied daily, according to a 12 hours of application/day dose regimen, and during a period of 4 weeks.
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Protection of trial subjects |
In case of insufficient pain relief, patients were allowed to take the rescue medication (paracetamol 500 mg).
If needed, cold applications (up to a maximum of three applications lasting 20 minutes each and performed at least 2 hours before any pain assessment), and braces for casting were allowed, and their use was to be recorded on the patient diary.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
31 Mar 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 199
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Worldwide total number of subjects |
199
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EEA total number of subjects |
199
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
185
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From 65 to 84 years |
14
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85 years and over |
0
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Recruitment
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Recruitment details |
Study Initiation Date: (First Patient First Visit) 31 March 2015 Study Completion Date: (Last Patient Last Visit) 11 May 2016 | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 200 patients were screened and 199 were randomized to the assigned treatment | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||
Roles blinded |
Investigator, Monitor, Subject, Data analyst, Assessor | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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BMV 2.25 mg medicated plaster | ||||||||||||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
BMV 2.25 mg medicated plaster
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Medicated plaster
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Routes of administration |
Topical use
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Dosage and administration details |
topically applied once a day on the most painful area of the affected body site, i.e. the lateral epicondyle
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Medicated plaster
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Routes of administration |
Topical use
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Dosage and administration details |
topically applied once a day on the most painful area of the affected body site, i.e. the lateral epicondyle
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BMV 2.25 mg medicated plaster
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Pain Reduction | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Visit 5 (Day 28)
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Statistical analysis title |
Primary Endpoint | ||||||||||||
Comparison groups |
BMV 2.25 mg medicated plaster v Placebo
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Number of subjects included in analysis |
184
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.028 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
The study period was divided into 5 visits: baseline (Visit 1), Visit 2 (Day 7) Visit 3 (Day 14) Visit 4 (Day 21) Visit 5 (Day 28). Adverse Events were evaluated at each visit.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
BMV 2.25 mg medicated plaster
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |