EUCTR2009-010783-41-SE
Active, not recruiting
Not Applicable
Population pharmacokinetic and pharmacodynamic modeling of gabapentin in neuropathic pain - Effect of adjuvant pharmacotherapy
ppsala University0 sitesMay 14, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ppsala University
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Diagnosis of post\-traumatic neuropathic pain
- •\- Spontaneous pain intensity \=40 on a 0\-100 mm Visual Analogue Scale (VAS) or \=4 on a Numerical Rating Scale (NRS)
- •\- Man or woman \=18 years old
- •\- Informed consent to study participation
- •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
- •\- Presence of other type of pain as strong as or stronger than the neuropathic pain
- •\- Impaired kidney function (GFR \<30 ml/min)
- •\- Uncontrolled cardiovascular disease/hypertonia
- •\- Uncontrolled narrow\-angle glaucoma
- •\- Uncontrolled pulmonary disease
- •\- Epilepsia
- •\- Pregnancy
- •\- Woman of childbearing potential not using contraception or planning to become pregnant during the study period
- •\- Disability to understand and cooperate with study procedures
- •\- Allergy to study medications
Outcomes
Primary Outcomes
Not specified
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