Back to resultsImipramine and Pregabalin Combination in Painful Polyneuropathy
Primary Purpose
Polyneuropathy
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Imipramine
Pregabalin
Imipramine, pregabalin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polyneuropathy focused on measuring polyneuropathy, neuropathic pain, treatment
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.
Sites / Locations
- Department of Neurology, Aalborg Hospital
- Department of Neurology, Odense University Hospital
- Department of Neurology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Experimental
Placebo Comparator
Arm Label
Imipramine
Pregabalin
Imipramine plus pregabalin
Placebo
Arm Description
Imipramine tablets and placebo capsules to pregabalin
Pregabalin capsules and placebo tablets to imipramine
Imipramine tablets and pregabalin capsules
Placebo tablets to imipramine and placebo capsules to pregabalin
Outcomes
Primary Outcome Measures
Total pain intensity as measured by numeric rating scale 0-10 points.
Secondary Outcome Measures
Verbal pain relief scale with 6 classes
Specific 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)
Full Information
NCT ID
NCT01047488
First Posted
January 12, 2010
Last Updated
January 12, 2010
Sponsor
Odense University Hospital
Collaborators
Pfizer, Nycomed
1. Study Identification
Unique Protocol Identification Number
NCT01047488
Brief Title
Imipramine and Pregabalin Combination in Painful Polyneuropathy
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 Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
Collaborators
Pfizer, Nycomed
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathy
Keywords
polyneuropathy, neuropathic pain, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imipramine
Arm Type
Active Comparator
Arm Description
Imipramine tablets and placebo capsules to pregabalin
Arm Title
Pregabalin
Arm Type
Active Comparator
Arm Description
Pregabalin capsules and placebo tablets to imipramine
Arm Title
Imipramine plus pregabalin
Arm Type
Experimental
Arm Description
Imipramine tablets and pregabalin capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets to imipramine and placebo capsules to pregabalin
Intervention Type
Drug
Intervention Name(s)
Imipramine
Other Intervention Name(s)
Imipramin DAK
Intervention Description
Tablet 25 mg, 3 tablets evening (extensive metabolizers) or 1 tablet evening (poor metabolizers), daily, 5 weeks
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Capsule 75 mg, 2 capsules twice daily, daily, 5 weeks
Intervention Type
Drug
Intervention Name(s)
Imipramine, pregabalin
Other Intervention Name(s)
Imipramin DAK, Lyrica
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Total pain intensity as measured by numeric rating scale 0-10 points.
Time Frame
Median of ratings from last week of each treatment period
Secondary Outcome Measure Information:
Title
Verbal pain relief scale with 6 classes
Time Frame
End of each treatment period
Title
Specific pain symptom rated by numeric rating scales 0-10 points
Time Frame
Median of ratings from last week of each treatment period
Title
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
Title
Sleep disturbance as measured by numeric rating scale 0-10 points
Time Frame
Median of ratings from last week of each treatment period
Title
Consumption of escape medication (number of tablets of paracetamol)
Time Frame
Total consumption during last week of each treatment period
Title
Health related quality of life (SF-36)
Time Frame
End of each treatment period
Title
Major Depression Inventory (MDI)
Time Frame
End of each treament period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Søren H. Sindrup, MD
Phone
+45 65412471
Email
soeren.sindrup@ouh.regionsyddanmark.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob V. Holbech, MD
Email
Holbech@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren H. Sindrup, MD
Organizational Affiliation
Department of Neurology, Odense University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jakob V. Holbech, MD
Organizational Affiliation
Department of Neurology, Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Aalborg Hospital
City
Aalborg
ZIP/Postal Code
DK-9000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flemming W. Bach, MD
Phone
+45 99321928
Email
fwb@rn.dk
First Name & Middle Initial & Last Name & Degree
Flemming W. Bach, MD
Facility Name
Department of Neurology, Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Søren H. Sindrup, MD
Phone
+45 65412471
Email
soeren.sindrup@ouh.regionsyddanmark.dk
First Name & Middle Initial & Last Name & Degree
Jakob V. Holbech, MD
Email
Holbech@dadlnet.dk
First Name & Middle Initial & Last Name & Degree
Søren H. Sindrup, MD
First Name & Middle Initial & Last Name & Degree
Jakob V. Holbech, MD
Facility Name
Department of Neurology, Aarhus University Hospital
City
Århus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Troels S. Jensen, MD
Phone
+45 89494137
Email
tsjensen@ki.au.dk
First Name & Middle Initial & Last Name & Degree
Nanna Finnerup, MD
Email
finnerup@ki.au.dk
First Name & Middle Initial & Last Name & Degree
Troels S. Jensen, MD
First Name & Middle Initial & Last Name & Degree
Nanna Finnerup, MD
12. IPD Sharing Statement
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Imipramine and Pregabalin Combination in Painful Polyneuropathy
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