Imipramine and Pregabalin Combination in Painful Polyneuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Odense University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Pfizer
Nycomed
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01047488
First received: January 12, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Polyneuropathy
Drug: Imipramine
Drug: Pregabalin
Drug: Imipramine, pregabalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Total pain intensity as measured by numeric rating scale 0-10 points. [ Time Frame: Median of ratings from last week of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Verbal pain relief scale with 6 classes [ Time Frame: End of each treatment period ] [ Designated as safety issue: No ]
  • Specific pain symptom rated by numeric rating scales 0-10 points [ Time Frame: Median of ratings from last week of each treatment period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Sleep disturbance as measured by numeric rating scale 0-10 points [ Time Frame: Median of ratings from last week of each treatment period ] [ Designated as safety issue: No ]
  • Consumption of escape medication (number of tablets of paracetamol) [ Time Frame: Total consumption during last week of each treatment period ] [ Designated as safety issue: No ]
  • Health related quality of life (SF-36) [ Time Frame: End of each treatment period ] [ Designated as safety issue: No ]
  • Major Depression Inventory (MDI) [ Time Frame: End of each treament period ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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:
  • Imipramin DAK
  • Lyrica
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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047488

Contacts
Contact: Søren H. Sindrup, MD +45 65412471 soeren.sindrup@ouh.regionsyddanmark.dk
Contact: Jakob V. Holbech, MD Holbech@dadlnet.dk

Locations
Denmark
Department of Neurology, Aalborg Hospital Not yet recruiting
Aalborg, Denmark, DK-9000
Contact: Flemming W. Bach, MD    +45 99321928    fwb@rn.dk   
Principal Investigator: Flemming W. Bach, MD         
Department of Neurology, Odense University Hospital Not yet recruiting
Odense, Denmark, DK-5000
Contact: Søren H. Sindrup, MD    +45 65412471    soeren.sindrup@ouh.regionsyddanmark.dk   
Contact: Jakob V. Holbech, MD       Holbech@dadlnet.dk   
Principal Investigator: Søren H. Sindrup, MD         
Principal Investigator: Jakob V. Holbech, MD         
Department of Neurology, Aarhus University Hospital Not yet recruiting
Århus, Denmark, DK-8000
Contact: Troels S. Jensen, MD    +45 89494137    tsjensen@ki.au.dk   
Contact: Nanna Finnerup, MD       finnerup@ki.au.dk   
Principal Investigator: Troels S. Jensen, MD         
Sub-Investigator: Nanna Finnerup, MD         
Sponsors and Collaborators
Odense University Hospital
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
  More Information

No publications provided

Responsible Party: Søren Hein Sindrup, Department of Neurology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01047488     History of Changes
Other Study ID Numbers: tcapgbcomb1, 2009-013642-80
Study First Received: January 12, 2010
Last Updated: January 12, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Odense University Hospital:
polyneuropathy
neuropathic pain
treatment

Additional relevant MeSH terms:
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Imipramine
Pregabalin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 18, 2014