Trial intelligence / Profile preview

Pregabalin for Pain in Critical Limb Ischemia

NCT00403780Phase 4

Key facts

Status: Terminated
Start: Jun 2006
Primary completion: May 2013
Countries: 1
Sponsor: Karolinska Institutet
Modality: Small Molecules

Drugs: pregabalin
Conditions: critical limb ischemia (CLI)

Overview

Phase 4, randomised, double-blind trial in critical limb ischemia (CLI) comparing Pregabalin with Placebo (2 arms). Primary endpoint: Reduction in Rating Scale (RS) pain at 8 weeks. Started Jun 2006; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Pregabalin
Pregabalin 75mg capsules titrated to 600mg/day + regular pain regimens
Placebo
Placebo capsules + regular pain regimens

Who it enrols

Patients with critical limb ischemia and rest pain for at least 2 weeks, aged 55 or older. Excludes patients with renal failure (CrCl <30), hypotension (SBP <120), or history of dizziness.

Endpoints

Primary

Reduction in Rating Scale (RS) pain8 weeks

Secondary

Short Form 36 (SF-36) parameter 'bodily pain'8 weeks
Amount, dose and duration of concomitant pain medication use2 weeks
Safety outcomes and adverse events8 weeks

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