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
Recruitment status was Not yet recruiting
Sponsor:
Odense University Hospital
Collaborators:
Pfizer
Nycomed: A Takeda Company
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
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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:
|
|
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
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: A Takeda Company
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 |
ClinicalTrials.gov processed this record on May 23, 2013