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pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia

pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-004002-14-NL
Enrollment
Unknown
Registered
2008-06-23
Start date
2009-03-16
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subjects suffer from fibromyalgia

Interventions

Pharmaceutical Form: Intravenous infusion INN or Proposed INN: KETAMINE HYDROCHLORIDE CAS Number: 1867669 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration numb

Sponsors

TREND
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: pain reduction of fibromyalgia related pain improvement of quality of life;Secondary Objective: pharmacokinetic-pharmacodynamic analysis of ketamine in fybromyalgia patients;Primary end point(s): pain score score on fibromyalgia impact questionnaire—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026