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Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia

NCT00403780 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-06-15

No results posted yet for this study

Summary

The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to the regular pain regimens for these patients.

Conditions

  • Critical Limb Ischemia
  • Arterial Occlusive Disease
  • Pain
  • Ischemia

Interventions

DRUG

pregabalin

Capsule pregabalin 75 mg once or twice daily up to a total dose of 600mg daily (300mg twice daily) for a total of minimum 14 days and maximum 8 weeks. Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily.

DRUG

placebo

Capsule placebo once or twice daily up to a total dose of 8 capsules(4 capsules twice daily) for a total of minimum 14 days and maximum 8 weeks. Dosage will be up titrated during first study week according to a prespecified scheme, starting with one capsule daily.

Sponsors & Collaborators

Principal Investigators

  • Eric Wahlberg, MD. PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-05-31
Completion
2015-07-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00403780 on ClinicalTrials.gov