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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2004-001845-13-IT |
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Date of registration:
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07/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase II, multicentre, multinational, prospective, randomised, double-blind, placebo controlled study assessing the efficacy and safety of a single application of three doses of Dysport in patients with upper back Myofascial Pain Syndrome (MPS)
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Scientific title:
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A Phase II, multicentre, multinational, prospective, randomised, double-blind, placebo controlled study assessing the efficacy and safety of a single application of three doses of Dysport in patients with upper back Myofascial Pain Syndrome (MPS) |
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Date of first enrolment:
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14/04/2005 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001845-13 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Czech Republic
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Germany
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Italy
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United Kingdom
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Contacts
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Upper back Myofascial Pain Syndrome (MPS)
MedDRA version: 6.1
Level: PT
Classification code 10048780
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Intervention(s)
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Trade Name: DYSPORT*500UI IM SC 2FL
Product Name: NA
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum toxin
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 500-
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Primary Outcome(s)
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Main Objective:
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Primary end point(s):
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Secondary Objective:
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Secondary ID(s)
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2004-001845-13-DE
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Y-47-52120-722
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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