Imipramine and Pregabalin Combination in Painful Polyneuropathy

January 12, 2010 updated by: Odense University Hospital

Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Department of Neurology, Aalborg Hospital
        • Contact:
          • Flemming W. Bach, MD
          • Phone Number: +45 99321928
          • Email: fwb@rn.dk
        • Principal Investigator:
          • Flemming W. Bach, MD
      • Odense, Denmark, DK-5000
        • Department of Neurology, Odense University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Søren H. Sindrup, MD
        • Principal Investigator:
          • Jakob V. Holbech, MD
      • Århus, Denmark, DK-8000
        • Department of Neurology, Aarhus University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Troels S. Jensen, MD
        • Sub-Investigator:
          • Nanna Finnerup, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Imipramine
Imipramine tablets and placebo capsules to pregabalin
Drug: Imipramine
Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks
Other Names:
  • Imipramin DAK
Active Comparator: Pregabalin
Pregabalin capsules and placebo tablets to imipramine
Drug: Pregabalin
Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
Other Names:
  • Lyrica
Experimental: Imipramine plus pregabalin
Imipramine tablets and pregabalin capsules
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
Other Names:
  • Lyrica
  • Imipramin DAK
Placebo Comparator: Placebo
Placebo tablets to imipramine and placebo capsules to pregabalin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total pain intensity as measured by numeric rating scale 0-10 points.
Time Frame: Median of ratings from last week of each treatment period
Median of ratings from last week of each treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Verbal pain relief scale with 6 classes
Time Frame: End of each treatment period
End of each treatment period
Specific pain symptom rated by numeric rating scales 0-10 points
Time Frame: Median of ratings from last week of each treatment period
Median of ratings from last week of each treatment period
Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points
Time Frame: End of each treatment period
End of each treatment period
Sleep disturbance as measured by numeric rating scale 0-10 points
Time Frame: Median of ratings from last week of each treatment period
Median of ratings from last week of each treatment period
Consumption of escape medication (number of tablets of paracetamol)
Time Frame: Total consumption during last week of each treatment period
Total consumption during last week of each treatment period
Health related quality of life (SF-36)
Time Frame: End of each treatment period
End of each treatment period
Major Depression Inventory (MDI)
Time Frame: End of each treament period
End of each treament period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

Pfizer
Nycomed

Investigators

  • Study Chair: Søren H. Sindrup, MD, Department of Neurology, Odense University Hospital
  • Principal Investigator: Jakob V. Holbech, MD, Department of Neurology, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tcapgbcomb1
  • 2009-013642-80 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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