/A
- Conditions
- Patients with fibromyalgia diagnosed according to ACR classification (1990) and with chronic pain at defined symmetrical body areas.
- Registration Number
- EUCTR2005-001587-31-SE
- Lead Sponsor
- SantoSolve AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Diagnosed fibromyalgia
Stable symptom duration for at least 1 year
Age 18-65 years
Written informed consent
Are the trial subjects under 18? no
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
Inflammatory reumatoid disease
Skin disorders
Established diagnosis of psoriasis
Established diagnosis of depression
Evident of any concomitant systemic disease or major surgery
Chronic treatment with opioids, NSAID's or other pain relieving drugs
BMI > 35
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate saftey and tolerability of the administered topical formulation of the study agent strontium.;Secondary Objective: To demonstrate pain relief as a proof of concept for the study formulation.;Primary end point(s): Safety:<br>Presence of local irritation at administration site (AE)<br>Presence of systemic adverse reactions (AE)<br>Systemic uptake of strontium (Cmax, Tmax and Half-life)<br>Ackumulation of strontium after single dose and repeated administration (AUC)<br><br>Efficacy:<br>Pain relieving effect measured by the patient on Visual Analoge Scales (VAS) and objective measurement of pain treshhold using an Algometer test.
- Secondary Outcome Measures
Name Time Method