Patients with fibromyalgia diagnosed according to ACR classification (1990) and with chronic pain at defined symmetrical body areas.
Conditions
Interventions
Product Name: 2PX
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Strontium chloride hexahydrate
CAS Number: 10025-70-4
Concentration unit: % (W/V) percent weight/volume
Concentration typ
Sponsors
SantoSolve AS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: Presence of local irritation at administration site (AE) Presence of systemic adverse reactions (AE) Systemic uptake of strontium (Cmax, Tmax and Half-life) Ackumulation of strontium after single dose and repeated administration (AUC) Efficacy: Pain relieving effect measured by the patient on Visual Analoge Scales (VAS) and objective measurement of pain treshhold using an Algometer test. | — |
Countries
Sweden
Outcome results
None listed