Imipramine and Pregabalin Combination in Painful Polyneuropathy

Polyneuropathy Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01047488
• Other study ID #: tcapgbcomb1
• Secondary ID: 2009-013642-80
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: January 2010
• Source: Odense University Hospital
• Contact: Søren H. Sindrup, MD
• Phone: +45 65412471
• Email: soeren.sindrup[@]ouh.regionsyddanmark.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polyneuropathies
• Polyneuropathy

Intervention

Drug:
• 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
• 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
• 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

Locations

Country	Name	City	State
Denmark	Department of Neurology, Aalborg Hospital	Aalborg
Denmark	Department of Neurology, Aarhus University Hospital	Århus
Denmark	Department of Neurology, Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Nycomed, Pfizer

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pain intensity as measured by numeric rating scale 0-10 points.		Median of ratings from last week of each treatment period	No
Secondary	Verbal pain relief scale with 6 classes		End of each treatment period	No
Secondary	Specific pain symptom rated by numeric rating scales 0-10 points		Median of ratings from last week of each treatment period	No
Secondary	Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points		End of each treatment period	No
Secondary	Sleep disturbance as measured by numeric rating scale 0-10 points		Median of ratings from last week of each treatment period	No
Secondary	Consumption of escape medication (number of tablets of paracetamol)		Total consumption during last week of each treatment period	No
Secondary	Health related quality of life (SF-36)		End of each treatment period	No
Secondary	Major Depression Inventory (MDI)		End of each treament period	No