Post-traumatic neuropathic pain MedDRA version: 9.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Interventions
Product Name: gabapentin
Pharmaceutical Form: Capsule*
INN or Proposed INN: GABAPENTIN
CAS Number: 60142963
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration number:
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion 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
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To develop a population pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) model for gabapentin in neuropathic pain.;Secondary Objective: To investigate whether adjuvant therapy of venlafaxine or donepezil contributes to improved analgesic efficacy in neuropathic pain patients treated with gabapentin. To investigate whether adjuvant therapy of venlafaxine or donepezil contributes to improved health-related quality of life, assessed by the questionnare SF-36, in neuropathic pain patients treated with gabapentin.;Primary end point(s): Development of a model describing the relationship between dose, concentration and effect for gabapentin in the treatment of neuropathic pain. | — |
Countries
Sweden
Outcome results
None listed