Imipramine and Pregabalin Combination in Painful Polyneuropathy

NCT ID: NCT01047488

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Imipramine

Imipramine tablets and placebo capsules to pregabalin

Group Type: ACTIVE_COMPARATOR

Imipramine

Intervention Type: DRUG

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

Pregabalin

Pregabalin capsules and placebo tablets to imipramine

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

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

Imipramine plus pregabalin

Imipramine tablets and pregabalin capsules

Group Type: EXPERIMENTAL

Imipramine, pregabalin

Intervention Type: DRUG

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

Placebo

Placebo tablets to imipramine and placebo capsules to pregabalin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Imipramine

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

Intervention Type: DRUG

Pregabalin

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Imipramin DAK; Lyrica; Imipramin DAK; Lyrica

Eligibility Criteria

Inclusion Criteria

• Age between 20 - 85 years.
• Characteristic symptoms of polyneuropathy for at least 6 months.
• Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
• Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
• Pain present at least 4 days a week.
• For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months.
• For other secondary polyneuropathies: stable for at least 6 months.
• For fertile females: adequate anticonceptive treatment.
• Written informed consent.

Exclusion Criteria

• Other cause of pain.
• Contraindications against imipramine.
• Allergic reactions towards imipramine or pregabalin.
• Known adverse reactions during imipramine or pregabalin treatment.
• Pregnancy.
• Severe systemic disease.
• Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor.
• Inability to follow study protocol.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Nycomed

INDUSTRY

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of Neurology, Odense University Hospital

Principal Investigators

Søren H. Sindrup, MD

Role: STUDY_CHAIR

Department of Neurology, Odense University Hospital

Jakob V. Holbech, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Odense University Hospital

Locations

Department of Neurology, Aalborg Hospital

Aalborg, , Denmark

Department of Neurology, Aarhus University Hospital

Aarhus, , Denmark

Department of Neurology, Odense University Hospital

Odense, , Denmark

Countries

Denmark

Central Contacts

Søren H. Sindrup, MD

Role: CONTACT

soeren.sindrup@ouh.regionsyddanmark.dk

+45 65412471

Jakob V. Holbech, MD

Role: CONTACT

Holbech@dadlnet.dk

Facility Contacts

Flemming W. Bach, MD

Role: primary

fwb@rn.dk

+45 99321928

Troels S. Jensen, MD

Role: primary

tsjensen@ki.au.dk

+45 89494137

Nanna Finnerup, MD

Role: backup

finnerup@ki.au.dk

Søren H. Sindrup, MD

Role: primary

soeren.sindrup@ouh.regionsyddanmark.dk

+45 65412471

Jakob V. Holbech, MD

Role: backup

Holbech@dadlnet.dk

Other Identifiers

2009-013642-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

tcapgbcomb1

Identifier Type: -

Identifier Source: org_study_id