Imipramine and Pregabalin Combination in Painful Polyneuropathy
Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polyneuropathy
Intervention: Imipramine (Drug); Pregabalin (Drug); Imipramine, pregabalin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Odense University Hospital Official(s) and/or principal investigator(s): Søren H. Sindrup, MD, Study Chair, Affiliation: Department of Neurology, Odense University Hospital Jakob V. Holbech, MD, Principal Investigator, Affiliation: Department of Neurology, Odense University Hospital
Overall contact: Søren H. Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.regionsyddanmark.dk
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.
Clinical Details
Official title: Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Total pain intensity as measured by numeric rating scale 0-10 points.
Secondary outcome: Verbal pain relief scale with 6 classesSpecific pain symptom rated by numeric rating scales 0-10 points Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points Sleep disturbance as measured by numeric rating scale 0-10 points Consumption of escape medication (number of tablets of paracetamol) Health related quality of life (SF-36) Major Depression Inventory (MDI)
Eligibility
Minimum age: 20 Years.
Maximum age: 85 Years.
Gender(s): Both.
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.
Locations and Contacts
Søren H. Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.regionsyddanmark.dk
Department of Neurology, Aalborg Hospital, Aalborg DK-9000, Denmark; Not yet recruiting Flemming W. Bach, MD, Phone: +45 99321928, Email: fwb@rn.dk Flemming W. Bach, MD, Principal Investigator
Department of Neurology, Odense University Hospital, Odense DK-5000, Denmark; Not yet recruiting Søren H. Sindrup, MD, Phone: +45 65412471, Email: soeren.sindrup@ouh.regionsyddanmark.dk Jakob V. Holbech, MD, Email: Holbech@dadlnet.dk Søren H. Sindrup, MD, Principal Investigator Jakob V. Holbech, MD, Principal Investigator
Department of Neurology, Aarhus University Hospital, Århus DK-8000, Denmark; Not yet recruiting Troels S. Jensen, MD, Phone: +45 89494137, Email: tsjensen@ki.au.dk Nanna Finnerup, MD, Email: finnerup@ki.au.dk Troels S. Jensen, MD, Principal Investigator Nanna Finnerup, MD, Sub-Investigator
Additional Information
Starting date: February 2010
Last updated: January 12, 2010
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