Population pharmacokinetic and pharmacodynamic modeling of gabapentin in neuropathic pain - Effect of adjuvant pharmacotherapy

• Conditions: Post-traumatic neuropathic pain; MedDRA version: 9.1Level: LLTClassification code 10054095Term: Neuropathic pain

• Registration Number: EUCTR2009-010783-41-SE
• Lead Sponsor: ppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-14
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified