pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia
- Conditions
- subjects suffer from fibromyalgia
- Registration Number
- EUCTR2008-004002-14-NL
- Lead Sponsor
- TREND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
fibromyalgia patients
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Obesity (BMI > 30);
Presence of psychiatric disease;
History of chronic alcohol or drug use;
Known allergy to study medications;
Possibility of pregnancy; and
Lactation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: pain reduction of fibromyalgia related pain<br>improvement of quality of life;Secondary Objective: pharmacokinetic-pharmacodynamic analysis of ketamine in fybromyalgia patients;Primary end point(s): pain score<br>score on fibromyalgia impact questionnaire
- Secondary Outcome Measures
Name Time Method