Population Pharmacokinetic-pharmacodynamic (PK-PD) Modeling of Co-administered Gabapentin in Neuropathic Pain

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 are to investigate whether adjuvant therapy of venlafaxine or donepezil contributes to 1) improved analgesic efficacy and 2) improved health-related quality of life (assessed by the SF-36 questionnaire) in neuropathic pain patients treated with gabapentin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University
• Collaborator: University of Copenhagen
• Treatments: Donepezil; Gabapentin; gamma-Aminobutyric Acid; Venlafaxine Hydrochloride

Criteria

Inclusion Criteria:

• 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 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