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Imipramine and Pregabalin Combination in Painful Polyneuropathy

NCT01047488 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2010-01-13

No results posted yet for this study

Summary

Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.

This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.

Conditions

  • Polyneuropathy

Interventions

DRUG

Imipramine

Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks

DRUG

Pregabalin

Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks

DRUG

Imipramine, pregabalin

Imipramine: tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks Pregabalin: capsule 75 mg, 2 capsules twice daily, daily, 5 weeks

DRUG

Placebo

Placebo tablets to imipramine 25 mg, 3 or 1 tablet evening, daily, 5 weeks Placebo capsules to pregabalin 75 mg, 2 capsules daily, daily, 5 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Nycomed

    collaborator INDUSTRY

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Søren H. Sindrup, MD · Department of Neurology, Odense University Hospital

  • Jakob V. Holbech, MD · Department of Neurology, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
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 NCT01047488 on ClinicalTrials.gov