Status:
COMPLETED
Population Pharmacokinetic-pharmacodynamic (PK-PD) Modeling of Co-administered Gabapentin in Neuropathic Pain
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
University of Copenhagen
Conditions:
Post-traumatic Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to develop a pharmacokinetic (PK) and a pharmacokinetic-pharmacodynamic (PK-PD) model for gabapentin in patients with neuropathic pain. The secondary objectives...
Detailed Description
Neuropathic pain is estimated to affect 2-3 % of the population and the condition is difficult to treat with conventional analgesics. The drug of first choice is typically a tricyclic antidepressant d...
Eligibility Criteria
Inclusion
- Diagnosis of post-traumatic neuropathic pain
- Spontaneous pain intensity ≥ 40 on VAS or ≥ 4 on NRS
- Man or woman ≥ 18 years old
- Informed consent to study participation
Exclusion
- 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
- Nursing
- 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
- Concomitant participation in other clinical study
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00967707
Start Date
August 1 2009
End Date
September 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
Multidisciplinary Pain Centre, Uppsala University Hospital
Uppsala, Sweden, 75185