Randomised, double-blind, placebo-controlled trial of the effect of the combination of imipramine and pregabalin for the treatment of painful polyneuropathy
- Conditions
- Painful polyneuropathy (idiopathic, diabetic, alcoholic, drug-induced and other etiologies)MedDRA version: 12.0Level: LLTClassification code 10036105Term: Polyneuropathy
- Registration Number
- EUCTR2009-013642-80-DK
- Lead Sponsor
- Department of Neurology, Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
1. Age 20-85 years
2. Polyneuropathy diagnosis confirmed by nerve conduction studies
3. Polyneuropathic pain symptoms for at least 6 months
4. Average baseline pain score of at least 4 on a 0-10 numeric rating scale
5. Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Additional cause of pain
2. Allergic reactions towards imipramin or pregabalin
3. Contraindikations towards imipramin
4. Pregnancy or breast feeding period
5. Severe illness
6. Treatment with antidepressants, anticonvulsants, opioids, antipsycotics or monoamin oxidase inhibitors.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if the combination of imipramin and pregabalin relieves painful polyneuropathy better than monotherapy with each of the drugs.;Secondary Objective: To determine if the combination provides relief of specific pain symptoms, improves quality of life and reduces pain-induced sleep disturbance. <br>;Primary end point(s): Patient mean ratings of total pain on a 0-10 point numerical rating scale during the last week of each treatment period.
- Secondary Outcome Measures
Name Time Method